Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:18 PM
Study NCT ID:
NCT05683158
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Compensatory Kinematic Movements in Various Directions After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jose.casana@uv.es', 'phone': '+34 656-437-371', 'title': 'PI. Jose Casaña Granell', 'organization': 'Department of Physiotherapy, University of Valencia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'the absence of randomization increased the risk of confounding bias.'}}, 'adverseEventsModule': {'description': 'It involved observation at a specific point in time without any intervention. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Trunk dislocation (mm)_Forward', 'categories': [{'measurements': [{'value': '272.44', 'spread': '88.63', 'groupId': 'OG000'}, {'value': '221.24', 'spread': '71.37', 'groupId': 'OG001'}]}]}, {'title': 'Trunk dislocation (mm)_Lateral', 'categories': [{'measurements': [{'value': '288.14', 'spread': '90.99', 'groupId': 'OG000'}, {'value': '253.50', 'spread': '74.54', 'groupId': 'OG001'}]}]}, {'title': 'Trunk dislocation (mm)_Medial', 'categories': [{'measurements': [{'value': '274.83', 'spread': '88.31', 'groupId': 'OG000'}, {'value': '230.76', 'spread': '80.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'estimateComment': 'Mean difference between two groups of movement unit in forward direction', 'groupDescription': 'To determine the sample size, the G\\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'Statistics difference among forward, ipsilateral and contralateral directions in within group', 'groupDescription': 'To determine the sample size, the G\\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': 'Trunk dislocation (reaching phase in millimetre; mm) in reaching task. The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.', 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'PRIMARY', 'title': 'Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Elbow extension_Forward', 'categories': [{'measurements': [{'value': '132.27', 'spread': '20.53', 'groupId': 'OG000'}, {'value': '131.97', 'spread': '9.26', 'groupId': 'OG001'}]}]}, {'title': 'Elbow extension_Lateral', 'categories': [{'measurements': [{'value': '133.70', 'spread': '19.44', 'groupId': 'OG000'}, {'value': '135.20', 'spread': '13.20', 'groupId': 'OG001'}]}]}, {'title': 'Elbow extension_Medial', 'categories': [{'measurements': [{'value': '127.04', 'spread': '24.93', 'groupId': 'OG000'}, {'value': '127.46', 'spread': '12.31', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder flexion_Forward', 'categories': [{'measurements': [{'value': '131.49', 'spread': '19.39', 'groupId': 'OG000'}, {'value': '123.29', 'spread': '18.12', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder flexion_Lateral', 'categories': [{'measurements': [{'value': '130.95', 'spread': '21.43', 'groupId': 'OG000'}, {'value': '128.64', 'spread': '13.39', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder flexion_Medial', 'categories': [{'measurements': [{'value': '135.00', 'spread': '18.55', 'groupId': 'OG000'}, {'value': '123.67', 'spread': '13.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': 'Elbow extension and shoulder flexion angle (degree) in reaching task. The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.', 'unitOfMeasure': 'Degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'PRIMARY', 'title': 'Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Movement unit_Forward', 'categories': [{'measurements': [{'value': '4.47', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Movement unit_Lateral', 'categories': [{'measurements': [{'value': '5.02', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Movement unit_Medial', 'categories': [{'measurements': [{'value': '4.11', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': 'Movement units are quantified by counting velocity peaks during the reaching task. A movement unit is defined as a velocity profile segment between a local minimum and the following maximum velocity that exceeds 20 mm/s, with a minimum time interval of 150 ms between subsequent peaks. This measure represents the smoothness of movement, where fewer movement units indicate smoother motion The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.', 'unitOfMeasure': 'number of peaks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'PRIMARY', 'title': 'Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Total time_Forward', 'categories': [{'measurements': [{'value': '3.42', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Total time_Lateral', 'categories': [{'measurements': [{'value': '3.49', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Total time_Medial', 'categories': [{'measurements': [{'value': '3.26', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': 'The period from hand tangential velocity movement onset to offset was the total time (entire time of reach and return phase \\[second\\]). The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset.\n\nThe measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'PRIMARY', 'title': 'Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Elbow angular velocity_Forward', 'categories': [{'measurements': [{'value': '45.66', 'spread': '31.21', 'groupId': 'OG000'}, {'value': '75.40', 'spread': '39.87', 'groupId': 'OG001'}]}]}, {'title': 'Elbow angular velocity_Lateral', 'categories': [{'measurements': [{'value': '44.04', 'spread': '29.60', 'groupId': 'OG000'}, {'value': '76.47', 'spread': '43.44', 'groupId': 'OG001'}]}]}, {'title': 'Elbow angular velocity_Medial', 'categories': [{'measurements': [{'value': '53.74', 'spread': '37.60', 'groupId': 'OG000'}, {'value': '79.15', 'spread': '38.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': "Tangential velocity was computed for the hand marker's velocity. Peak elbow angular velocity (rad/s) during elbow extension were measured The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.", 'unitOfMeasure': 'rad/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'PRIMARY', 'title': 'Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Elbow angular acceleration_Forward', 'categories': [{'measurements': [{'value': '344.75', 'spread': '261.56', 'groupId': 'OG000'}, {'value': '628.85', 'spread': '270.49', 'groupId': 'OG001'}]}]}, {'title': 'Elbow angular acceleration_Lateral', 'categories': [{'measurements': [{'value': '321.28', 'spread': '199.17', 'groupId': 'OG000'}, {'value': '542.96', 'spread': '281.04', 'groupId': 'OG001'}]}]}, {'title': 'Elbow angular acceleration_Medial', 'categories': [{'measurements': [{'value': '396.78', 'spread': '320.56', 'groupId': 'OG000'}, {'value': '722.87', 'spread': '280.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': 'Acceleration (rad/s2) during elbow extension was measured The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.', 'unitOfMeasure': 'rad/s2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'PRIMARY', 'title': 'Difference of the Components Temporal Measurements Between Healthy and Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Hand velocity_Forward', 'categories': [{'measurements': [{'value': '944.52', 'spread': '610.70', 'groupId': 'OG000'}, {'value': '805.28', 'spread': '324.31', 'groupId': 'OG001'}]}]}, {'title': 'Hand velocity_Lateral', 'categories': [{'measurements': [{'value': '1003.22', 'spread': '634.69', 'groupId': 'OG000'}, {'value': '822.19', 'spread': '270.58', 'groupId': 'OG001'}]}]}, {'title': 'Hand velocity_Medial', 'categories': [{'measurements': [{'value': '1015.06', 'spread': '675.14', 'groupId': 'OG000'}, {'value': '1188.89', 'spread': '497.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 time (Baseline)', 'description': "Tangential velocity was computed for the hand marker's velocity. The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset. Peak hand velocity (mm/s) was analyzed.\n\nThe measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.", 'unitOfMeasure': 'mm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'SECONDARY', 'title': 'Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Related Fugl-Meyer Assessment score(dependent) to predictors(independent) in three directions.\n\nIn sitting position, the sum of each subtotal score is 66 (maximum) and the minimum is 0. Subscales were summed to compute a total score. Cutoff scores defined 0\\~20: severe, 21 \\~ 50: moderate, 51\\~66: mild\n\n1\\) Reflex activity\\_max 4 score, 2) Volitional movement within synergies\\_ max 18, 3) Volitional movement mixing synergies\\_ max 6, 4) Volitional movement with little or no synergy\\_ max 6, 5) Normal reflex activity\\_max 2, 6) Wrist movement\\_ max 10, 7) Hand movement with grasp\\_ max 14, 8) coordination/speed\\_max 6.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comparison of Modified Ashworth Scale Between Chronic Stroke Patients and Healthy Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Scoring for Biceps\n\n* MAS 0: No increase in tone\n* MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.\n* MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )\n* MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed\n* MAS 3: considerable increase in tone, passive movement difficult\n* MAS 4: limb rigid in flexion or extension The Modified Ashworth Scale (MAS) ranges from 0 to 4, where higher scores indicate more severe spasticity/increased muscle tone. A score of 0 represents normal muscle tone, while 4 represents the most severe level of spasticity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Range of motion_Health Status Chronic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'title': 'Shoulder flexion', 'categories': [{'measurements': [{'value': '161.46', 'spread': '22.16', 'groupId': 'OG000'}, {'value': '179.02', 'spread': '7.68', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder abduction', 'categories': [{'measurements': [{'value': '149.57', 'spread': '34.11', 'groupId': 'OG000'}, {'value': '179.26', 'spread': '5.76', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder adduction', 'categories': [{'measurements': [{'value': '44.77', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '50.00', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder external rotation', 'categories': [{'measurements': [{'value': '71.86', 'spread': '19.18', 'groupId': 'OG000'}, {'value': '89.51', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Shoulder internal rotation', 'categories': [{'measurements': [{'value': '76.94', 'spread': '19.79', 'groupId': 'OG000'}, {'value': '87.70', 'spread': '8.09', 'groupId': 'OG001'}]}]}, {'title': 'Elbow flexion', 'categories': [{'measurements': [{'value': '139.63', 'spread': '7.29', 'groupId': 'OG000'}, {'value': '144.18', 'spread': '3.05', 'groupId': 'OG001'}]}]}, {'title': 'Elbow extension', 'categories': [{'measurements': [{'value': '1.94', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Shoulder and elbow joint range of motion\n\n* Shoulder flexion, adduction, abduction, external rotation, internal rotation\n* Elbow flexion, extension', 'unitOfMeasure': 'degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trunk Impairment Scale(TIS)_Health Status Chronic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '20'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 time(Baseline)', 'description': 'The Trunk Impairment Scale (TIS) for stroke has a total score of 23 points, with higher scores indicating better trunk control ability. TIS components:\n\nStatic sitting balance - 7 points Dynamic sitting balance - 10 points Coordination - 6 points 23 points = Optimal trunk control ability (normal performance of all items) 0 points = Minimal trunk control ability (unable to perform) Static sitting balance Dynamic sitting balance Co-ordination', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postural Assessment Scale for Stroke(PASS)_Health Status Chronic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '34'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'The Postural Assessment Scale for Stroke (PASS) evaluates postural control in stroke patients, with scores ranging from 0-36 points, where higher scores indicate better functional recovery.\n\n1\\) Sitting without support 2,3) Standing with(without) support 4,5) Standing on (non)paretic leg 6) Supine to affected side lateral 7) Supine to non-affected side lateral 8) Supine to sitting up on the edge of the table 9) Sitting on the edge of the table to supine 10) Sitting to standing up 11) Standing up to sitting down 12) Standing, picking up a pencil from the floor', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fugl_Meyer Assessment(FMA)_Health Status Chronic Stroke', 'timeFrame': 'Baseline', 'description': 'Upper extremity The total score means that severe \\<20, 20=\\<moderate\\<60, 60=\\<mild. Higher scores on the Fugl-Meyer Assessment indicate better upper limb motor control with reduced synergistic patterns, while lower scores indicate stronger synergistic patterns due to spasticity\n\n1\\) Reflex activity\\_max 4 score, 2) Volitional movement within synergies\\_ max 18, 3) Volitional movement mixing synergies\\_ max 6, 4) Volitional movement with little or no synergy\\_ max 6, 5) Normal reflex activity\\_max 2, 6) Wrist movement\\_ max 10, 7) Hand movement with grasp\\_ max 14, 8) coordination/speed\\_max 6.\n\n* Shoulder, Elbow and Forearm\n\n 1. Reflex activity\n 2. Volitional movement within synergies\n 3. Volitional movement mixing synergies\n 4. Volitional movement with little or no synergy\n 5. Normal reflex activity\n* Wrist\n* Hand\n* Coordination/Speed\n* Total score is 66 points', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Modified Ashworth Scale_Stiffness of Chronic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline', 'description': 'Scoring for Triceps\n\n* MAS 0: No increase in tone\n* MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.\n* MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )\n* MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed\n* MAS 3: considerable increase in tone, passive movement difficult\n* MAS 4: limb rigid in flexion or extension The Modified Ashworth Scale (MAS) ranges from 0 to 4, where higher scores indicate more severe spasticity/increased muscle tone. A score of 0 represents normal muscle tone, while 4 represents the most severe level of spasticity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed enrolled all participants with inclusion criteria between chronic stroke and healthy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'FG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were recruited based on physician's confirmation of chronic hemiplegia with ≥ 6 months onset and the healthy group consisted of individuals without any history of neurological or orthopedic diseases. The participants was enrolled from August, 2022 to June, 2023 at the gym for the disabled of Ulsan city and Ulsan national institute of science and technology", 'preAssignmentDetails': 'All of the subjects of 96 enrolled participants were inclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic Stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'id': 'BG001', 'title': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.80', 'spread': '13.81', 'groupId': 'BG000'}, {'value': '68.61', 'spread': '7.23', 'groupId': 'BG001'}, {'value': '68.67', 'spread': '10.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fugl-Meyer Assessment (FMA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '66', 'upperLimit': '66'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '61.25', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'description': 'Inclusion criteria: FMA upper extremity score ≥ 21 points (In sitting position, the sum of each subtotal score is 66 (maximum) and the minimum is 0. Subscales were summed to compute a total score Cutoff scores defined 21 \\~ 50: moderate, 51\\~66: mild\n\n1\\) Reflex activity\\_max 4 score, 2) Volitional movement within synergies\\_ max 18, 3) Volitional movement mixing synergies\\_ max 6, 4) Volitional movement with little or no synergy\\_ max 6, 5) Normal reflex activity\\_max 2, 6) Wrist movement\\_ max 10, 7) Hand movement with grasp\\_ max 14, 8) coordination/speed\\_max 6.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'To determine the sample size, the G\\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2. Consequently, a suitable number of participants were recruited, considering a comparison of 35 individuals in the stroke group and 61 individuals in the healthy group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-19', 'size': 3574113, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-02T01:10', 'hasProtocol': True}, {'date': '2022-07-19', 'size': 25239, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-02T01:24', 'hasProtocol': False}, {'date': '2022-07-19', 'size': 171010, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-02T01:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-02', 'studyFirstSubmitDate': '2022-12-21', 'resultsFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-01-05', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-02', 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of Modified Ashworth Scale Between Chronic Stroke Patients and Healthy Controls', 'timeFrame': 'Baseline', 'description': 'Scoring for Biceps\n\n* MAS 0: No increase in tone\n* MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.\n* MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )\n* MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed\n* MAS 3: considerable increase in tone, passive movement difficult\n* MAS 4: limb rigid in flexion or extension The Modified Ashworth Scale (MAS) ranges from 0 to 4, where higher scores indicate more severe spasticity/increased muscle tone. A score of 0 represents normal muscle tone, while 4 represents the most severe level of spasticity.'}, {'measure': 'Range of motion_Health Status Chronic Stroke', 'timeFrame': 'Baseline', 'description': 'Shoulder and elbow joint range of motion\n\n* Shoulder flexion, adduction, abduction, external rotation, internal rotation\n* Elbow flexion, extension'}, {'measure': 'Trunk Impairment Scale(TIS)_Health Status Chronic Stroke', 'timeFrame': '1 time(Baseline)', 'description': 'The Trunk Impairment Scale (TIS) for stroke has a total score of 23 points, with higher scores indicating better trunk control ability. TIS components:\n\nStatic sitting balance - 7 points Dynamic sitting balance - 10 points Coordination - 6 points 23 points = Optimal trunk control ability (normal performance of all items) 0 points = Minimal trunk control ability (unable to perform) Static sitting balance Dynamic sitting balance Co-ordination'}, {'measure': 'Postural Assessment Scale for Stroke(PASS)_Health Status Chronic Stroke', 'timeFrame': 'Baseline', 'description': 'The Postural Assessment Scale for Stroke (PASS) evaluates postural control in stroke patients, with scores ranging from 0-36 points, where higher scores indicate better functional recovery.\n\n1\\) Sitting without support 2,3) Standing with(without) support 4,5) Standing on (non)paretic leg 6) Supine to affected side lateral 7) Supine to non-affected side lateral 8) Supine to sitting up on the edge of the table 9) Sitting on the edge of the table to supine 10) Sitting to standing up 11) Standing up to sitting down 12) Standing, picking up a pencil from the floor'}, {'measure': 'Fugl_Meyer Assessment(FMA)_Health Status Chronic Stroke', 'timeFrame': 'Baseline', 'description': 'Upper extremity The total score means that severe \\<20, 20=\\<moderate\\<60, 60=\\<mild. Higher scores on the Fugl-Meyer Assessment indicate better upper limb motor control with reduced synergistic patterns, while lower scores indicate stronger synergistic patterns due to spasticity\n\n1\\) Reflex activity\\_max 4 score, 2) Volitional movement within synergies\\_ max 18, 3) Volitional movement mixing synergies\\_ max 6, 4) Volitional movement with little or no synergy\\_ max 6, 5) Normal reflex activity\\_max 2, 6) Wrist movement\\_ max 10, 7) Hand movement with grasp\\_ max 14, 8) coordination/speed\\_max 6.\n\n* Shoulder, Elbow and Forearm\n\n 1. Reflex activity\n 2. Volitional movement within synergies\n 3. Volitional movement mixing synergies\n 4. Volitional movement with little or no synergy\n 5. Normal reflex activity\n* Wrist\n* Hand\n* Coordination/Speed\n* Total score is 66 points'}, {'measure': 'Modified Ashworth Scale_Stiffness of Chronic Stroke', 'timeFrame': 'Baseline', 'description': 'Scoring for Triceps\n\n* MAS 0: No increase in tone\n* MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.\n* MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )\n* MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed\n* MAS 3: considerable increase in tone, passive movement difficult\n* MAS 4: limb rigid in flexion or extension The Modified Ashworth Scale (MAS) ranges from 0 to 4, where higher scores indicate more severe spasticity/increased muscle tone. A score of 0 represents normal muscle tone, while 4 represents the most severe level of spasticity.'}], 'primaryOutcomes': [{'measure': 'Differences in Spatial Measurements of Trunk Dislocation Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'timeFrame': '1 time (Baseline)', 'description': 'Trunk dislocation (reaching phase in millimetre; mm) in reaching task. The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.'}, {'measure': 'Differences in Spatial Measurements of Elbow and Shoulder Angle Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'timeFrame': '1 time (Baseline)', 'description': 'Elbow extension and shoulder flexion angle (degree) in reaching task. The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.'}, {'measure': 'Differences in Temporal Measurements of Movement Unit Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'timeFrame': '1 time (Baseline)', 'description': 'Movement units are quantified by counting velocity peaks during the reaching task. A movement unit is defined as a velocity profile segment between a local minimum and the following maximum velocity that exceeds 20 mm/s, with a minimum time interval of 150 ms between subsequent peaks. This measure represents the smoothness of movement, where fewer movement units indicate smoother motion The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.'}, {'measure': 'Differences in Temporal Measurements of Hand Movement Time Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'timeFrame': '1 time (Baseline)', 'description': 'The period from hand tangential velocity movement onset to offset was the total time (entire time of reach and return phase \\[second\\]). The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset.\n\nThe measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.'}, {'measure': 'Differences in Temporal Measurements of Hand Velocity Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'timeFrame': '1 time (Baseline)', 'description': "Tangential velocity was computed for the hand marker's velocity. Peak elbow angular velocity (rad/s) during elbow extension were measured The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements."}, {'measure': 'Differences in Temporal Measurements of Elbow Extension Acceleration Components During 3-directional Bell-reaching Task Between Healthy Subjects and Stroke Patients', 'timeFrame': '1 time (Baseline)', 'description': 'Acceleration (rad/s2) during elbow extension was measured The measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements.'}, {'measure': 'Difference of the Components Temporal Measurements Between Healthy and Stroke', 'timeFrame': '1 time (Baseline)', 'description': "Tangential velocity was computed for the hand marker's velocity. The period when the tangential velocity exceeded 10% of its peak was termed hand movement onset, whereas that when the tangential velocity stayed below 10% of its peak was termed hand movement offset. Peak hand velocity (mm/s) was analyzed.\n\nThe measurements are detected in 3 directions (Forward\\_90, Lateral\\_135, Medial\\_45 degree). Participants reach to a bell as quickly as possible. 3rd joint is calculated for quantitative measurements."}], 'secondaryOutcomes': [{'measure': 'Comparison of Fugl-Meyer Assessment Scores Between Chronic Stroke Patients and Healthy', 'timeFrame': 'Baseline', 'description': 'Related Fugl-Meyer Assessment score(dependent) to predictors(independent) in three directions.\n\nIn sitting position, the sum of each subtotal score is 66 (maximum) and the minimum is 0. Subscales were summed to compute a total score. Cutoff scores defined 0\\~20: severe, 21 \\~ 50: moderate, 51\\~66: mild\n\n1\\) Reflex activity\\_max 4 score, 2) Volitional movement within synergies\\_ max 18, 3) Volitional movement mixing synergies\\_ max 6, 4) Volitional movement with little or no synergy\\_ max 6, 5) Normal reflex activity\\_max 2, 6) Wrist movement\\_ max 10, 7) Hand movement with grasp\\_ max 14, 8) coordination/speed\\_max 6.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic stroke', 'Reaching task', 'Motion capture'], 'conditions': ['Cerebral Stroke', 'Hemiplegia, Spastic']}, 'referencesModule': {'references': [{'pmid': '29658937', 'type': 'BACKGROUND', 'citation': 'Alt Murphy M, Murphy S, Persson HC, Bergstrom UB, Sunnerhagen KS. Kinematic Analysis Using 3D Motion Capture of Drinking Task in People With and Without Upper-extremity Impairments. J Vis Exp. 2018 Mar 28;(133):57228. doi: 10.3791/57228.'}, {'pmid': '24481598', 'type': 'BACKGROUND', 'citation': "Wu CY, Liing RJ, Chen HC, Chen CL, Lin KC. Arm and trunk movement kinematics during seated reaching within and beyond arm's length in people with stroke: a validity study. Phys Ther. 2014 Jun;94(6):845-56. doi: 10.2522/ptj.20130101. Epub 2014 Jan 30."}, {'pmid': '30925379', 'type': 'BACKGROUND', 'citation': 'Machado LR, Heathcock J, Carvalho RP, Pereira ND, Tudella E. Kinematic characteristics of arm and trunk when drinking from a glass in children with and without cerebral palsy. Clin Biomech (Bristol). 2019 Mar;63:201-206. doi: 10.1016/j.clinbiomech.2019.03.011. Epub 2019 Mar 19.'}, {'pmid': '23181596', 'type': 'BACKGROUND', 'citation': 'Lobo-Prat J, Font-Llagunes JM, Gomez-Perez C, Medina-Casanovas J, Angulo-Barroso RM. New biomechanical model for clinical evaluation of the upper extremity motion in subjects with neurological disorders: an application case. Comput Methods Biomech Biomed Engin. 2014 Aug;17(10):1144-56. doi: 10.1080/10255842.2012.738199. Epub 2012 Nov 27.'}, {'pmid': '27000446', 'type': 'BACKGROUND', 'citation': 'Hsieh YW, Liing RJ, Lin KC, Wu CY, Liou TH, Lin JC, Hung JW. Sequencing bilateral robot-assisted arm therapy and constraint-induced therapy improves reach to press and trunk kinematics in patients with stroke. J Neuroeng Rehabil. 2016 Mar 22;13:31. doi: 10.1186/s12984-016-0138-5.'}, {'pmid': '10775539', 'type': 'BACKGROUND', 'citation': 'Cirstea MC, Levin MF. Compensatory strategies for reaching in stroke. Brain. 2000 May;123 ( Pt 5):940-53. doi: 10.1093/brain/123.5.940.'}, {'pmid': '11880893', 'type': 'BACKGROUND', 'citation': 'Levin MF, Michaelsen SM, Cirstea CM, Roby-Brami A. Use of the trunk for reaching targets placed within and beyond the reach in adult hemiparesis. Exp Brain Res. 2002 Mar;143(2):171-80. doi: 10.1007/s00221-001-0976-6. Epub 2002 Jan 8.'}, {'pmid': '11460767', 'type': 'BACKGROUND', 'citation': 'Adamovich SV, Archambault PS, Ghafouri M, Levin MF, Poizner H, Feldman AG. Hand trajectory invariance in reaching movements involving the trunk. Exp Brain Res. 2001 Jun;138(3):288-303. doi: 10.1007/s002210100694.'}, {'pmid': '9099186', 'type': 'BACKGROUND', 'citation': 'Dean CM, Shepherd RB. Task-related training improves performance of seated reaching tasks after stroke. A randomized controlled trial. Stroke. 1997 Apr;28(4):722-8. doi: 10.1161/01.str.28.4.722.'}, {'pmid': '10502647', 'type': 'BACKGROUND', 'citation': 'Dean C, Shepherd R, Adams R. Sitting balance I: trunk-arm coordination and the contribution of the lower limbs during self-paced reaching in sitting. Gait Posture. 1999 Oct;10(2):135-46. doi: 10.1016/s0966-6362(99)00026-0.'}, {'pmid': '32539738', 'type': 'BACKGROUND', 'citation': 'Thrane G, Sunnerhagen KS, Murphy MA. Upper limb kinematics during the first year after stroke: the stroke arm longitudinal study at the University of Gothenburg (SALGOT). J Neuroeng Rehabil. 2020 Jun 15;17(1):76. doi: 10.1186/s12984-020-00705-2.'}, {'pmid': '12819841', 'type': 'BACKGROUND', 'citation': 'Cirstea MC, Mitnitski AB, Feldman AG, Levin MF. Interjoint coordination dynamics during reaching in stroke. Exp Brain Res. 2003 Aug;151(3):289-300. doi: 10.1007/s00221-003-1438-0. Epub 2003 Jun 19.'}, {'pmid': '33585418', 'type': 'BACKGROUND', 'citation': 'Schwarz A, Veerbeek JM, Held JPO, Buurke JH, Luft AR. Measures of Interjoint Coordination Post-stroke Across Different Upper Limb Movement Tasks. Front Bioeng Biotechnol. 2021 Jan 28;8:620805. doi: 10.3389/fbioe.2020.620805. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This is cross-sectional study. By comparing kinematic analysis between stroke and healthy subjects in various directions, this investigation analyzes the compensatory kinematic movement for reaching task in stroke survivors', 'detailedDescription': 'After Institutional Review Board approval, It recruits 2 groups. one group is elderly and another group is stroke survivors. the stroke group that meets the criteria. Another group is age matching of the stroke and not having an orthopedic or neurological disease. Participants of all the groups are assessed for kinematic by motion capture During reaching arm(affected side; stroke group, non-dominant side; healthy group) in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees). Retroreflective markers are placed on 11 anatomical place (3th metacarpal joint, both acromion, elbow lateral and medial epicondyle, lateral and medial styloid process, xyphoid process, sternum, C7, T4). Participants reach to a bell as quickly as possible in three directions. The subject reach to a bell 5 times in each direction and assess clinical evaluation such as Fugl Meyer Assessment, Postural Assessment Scale, Modified Ashworth Scale, shoulder-elbow range of motion and Trunk Instability scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recruit research participants from the healthy group of 61 participants at the gym for the disabled of Ulsan city and Ulsan national institute of science and technology. Another group of 35 patients who enter the largest gym for the disabled of Ulsan city.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe inclusion criteria used in the randomized controlled trials were as follows:\n\nStroke\n\n* Subject consisted of the physician's confirmation of chronic hemiplegia\n* onset ≥ 6 months\n* Mini-mental state examination≥25\n* Biceps ≤2, Triceps≤2\n* Ability to Sit on a chair alone\n* FMA upper extremity score ≥ 21 points, FMA upper extremity ≤ 66 points\n\nHealthy\n\n* Age of matching the stroke group\n* Absence of neurological disease and orthopedic disease\n\nExclusion Criteria:\n\nStroke\n\n* Biceps\\>2, Triceps\\>2\n* Flaccid\n* Neglect syndrome\n* Have neurological disease and orthopedic disease\n* Lack of coordination"}, 'identificationModule': {'nctId': 'NCT05683158', 'briefTitle': 'Compensatory Kinematic Movements in Various Directions After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Compensatory Kinematic Movement for Reaching Task in Various Directions in After Stroke', 'orgStudyIdInfo': {'id': 'Kinematic movements of stroke'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic stroke', 'description': "The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)"}, {'label': 'Healthy', 'description': 'Matching aged people, not having neurological system or orthopedic disease on Upper extremity.\n\nThe subject reaches to target by non-dominant arm in 3 directions(medial\\_45, forward\\_90 and lateral\\_135 degrees)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44919', 'city': 'Ulsan', 'state': 'Ulju', 'country': 'South Korea', 'facility': 'Ulsan National Institute of Science and Technology', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Jóse Casaña Granell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Valencia'}, {'name': 'Joaquin Calatayud Villalba, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Valencia'}, {'name': 'Sang Hoon Kang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulsan National Institute of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ulsan National Institute of Science and Technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'José Casaña Granell', 'investigatorAffiliation': 'University of Valencia'}}}}