Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00833105
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D010243', 'term': 'Paralysis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cordop@ohsu.edu', 'phone': '503 418 2520', 'title': 'Dr. Paul Cordo', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. Not a controlled study.\n2. Zone of partial preservation not fully characterized.\n3. Changes in somatosensation were not quantified.\n4. Five participants were trained for both ULs, so training of first UL may have affected second UL.'}}, 'adverseEventsModule': {'timeFrame': 'Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)', 'eventGroups': [{'id': 'EG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.", 'otherNumAtRisk': 13, 'otherNumAffected': 5, 'seriousNumAtRisk': 13, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reduction in tenodesis', 'notes': 'Strength gain in finger flexors reduced ability to use tenodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'Subject accidentally pricked on ear lobe during sensory testing producing 1 drop of blood.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin abrasion', 'notes': 'Abrasion from vibrator probe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'Tripped over dog and fractured shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular soreness', 'notes': 'After first training session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Liver disease requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide', 'notes': 'Presumed due to depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Grasp Release Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Arms', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nThe AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '58.5', 'spread': '37.9', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '72.0', 'spread': '40.0', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '77.5', 'spread': '44.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.025', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effect'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.', 'unitOfMeasure': 'Objects moved', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Arms', 'denomUnitsSelected': 'Arms', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'ASIA Motor Key Muscles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '15.3', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '14.6', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '16.1', 'spread': '4.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.299', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effect'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'ISNCSCI Assessment of motor function (upper limb only). Scores on a scale ranging from 0 (i.e., total paralysis) - 5 (i.e., full range of motion) for each of 5 upper limb muscle groups. Total score represents the overall level of the upper limb impairment and represents the sum of the 5 scores from the 5 upper limb muscle groups. Accordingly, the total score has a range of 0-25, with 0 representing a completely paralyzed upper limb and 25 representing a normally functioning upper limb.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '14.1', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '13.8', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '14.5', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.459', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effect'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': "Measures the subject's sensory perception, with eyes closed, of a light touch by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '10.5', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '11.3', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '11.1', 'spread': '4.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.343', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effect'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': "Measures the subject's sensory perception, with eyes closed, of a light prick of a safety pin produced by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Van Lieshout Hand Function Test for Tetraplegia- Short Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '27.2', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '27.3', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '27.4', 'spread': '12.6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.951', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effects'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'Measures the functional movement in the upper limb of people with cervical spinal cord injury. The short version of this test includes a total of 10 different functional tasks to be performed by the subject with the upper limb. For example, one task is to reach and pick up a filled Coke bottle, set it down, and then replace it in its original position. Each task is scored on a scale of 0-5, 0 representing inability to perform the task and 5 representing normal movement. A single, total score is calculated as the sum of the scores on the 10 tasks, and therefore, has an overall range of 0-50, with higher scores representing better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Modified Ashworth Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '5.3', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '4.2', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.371', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effect'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'Measurement of joint stiffness (tone/spasticity). Score is based on sum of MAS value for 4 muscle groups: (1) Wrist/finger flexors, (2) Wrist/finger extensors, (3) elbow flexors, and (4) elbow extensors. Each muscle group and direction is score on a scale of 0 (no increase in muscle tone) to 5 (rigid), with a score of 2 used instead of 1+. A single overall score representing the sum of all 4 muscle groups and directions is used and has a range of 0-20 with higher scores representing more severe impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Capabilities of Upper Extremity Instrument', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '58.2', 'spread': '23.0', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '64.1', 'spread': '24.6', 'groupId': 'OG000'}]}]}, {'title': '3 Month Follow-up', 'categories': [{'measurements': [{'value': '63.8', 'spread': '25.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.164', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Random subject effect'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'Subjective questionnaire of participants\' self-perceptions of upper limb function that contains 17 questions relating to the use of the right upper limb, the same 17 relating to the use of the lower upper limb, plus two additional questions relating to bimanual function. Responses to each item of the questionnaire has a range of 1 (i.e., "totally limited") to 7 (i.e., "not at all limited"). A total cumulative score used for the study is based on the sum of the responses to all 34 questions (i.e., 16 right arm, 16 left arm, 2 both arms), and therefore has a cumulative score range of 32 - 224, with higher scores indicating more function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Strength Test - Thumb/Finger Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.', 'statisticalMethod': 'Wilcoxon Signed-Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No multiple comparison procedure'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum strength of thumb-and-fingers in extension.\n\nPre-training score is average of a total of 3 scores, including 1 score from each of the first 3 days of training. Post-training score is average of a total of 3 scores, including 1 score from each of the last 3 days of training.', 'unitOfMeasure': 'Newton*meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Strength Test - Thumb/Fingers Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '2.10', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '2.87', 'spread': '2.94', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'No multiple comparison procedure performed', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum strength of Thumb/fingers in Flexion\n\nPre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.', 'unitOfMeasure': 'Newton*meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Strength Test - Wrist Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '2.27', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '3.51', 'spread': '2.02', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'No multiple comparison procedure', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum wrist strength in extension\n\nPre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.', 'unitOfMeasure': 'Newton*meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Strength Test - Wrist Flexion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '5.41', 'spread': '3.31', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '7.95', 'spread': '4.98', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'No multiple comparison adjustment.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum strength in flexion direction\n\nPre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.', 'unitOfMeasure': 'Newton*meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Active Motion Test - Fingers/Thumb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '6.95', 'spread': '5.98', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '10.63', 'spread': '7.20', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'No multiple comparison adjustment.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Tracking task for the thumb and finger, i.e., opening and closing the hand. The participant tracks a target box on a video screen by actively moving the thumb and fingers, first in the opening direction, then closing, and finally opeining again. The participant\'s thumb-and-finger position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The "Pre-training Score" is the average score obtained during the first 3 days of training, and the Post-training Score" is average score obtained during the last 3 days of training.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}, {'type': 'SECONDARY', 'title': 'Active Motion Test - Wrist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Upper Limbs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'classes': [{'title': 'Pre-training', 'categories': [{'measurements': [{'value': '18.50', 'spread': '11.27', 'groupId': 'OG000'}]}]}, {'title': 'Post-training', 'categories': [{'measurements': [{'value': '26.62', 'spread': '11.77', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'No multiple comparisons adjustment.', 'statisticalMethod': 'Wilcoxon Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Tracking task for the wrist, i.e., flexing (i.e., pull with the front of the hand) and extending (i.e., pushing with the back of the hand). The participant tracks a target box on a video screen by actively moving the hand at the wrist, first in the extension direction, then flexion, and finally extension again. The participant\'s wrist position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The "Pre-training Score" is the average score obtained during the first 3 days of training, and the Post-training Score" is average score obtained during the last 3 days of training.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Upper Limbs', 'denomUnitsSelected': 'Upper Limbs', 'populationDescription': 'Analysis population is "arms." Three subjects dropped out. Five of the remaining subjects were tested for both arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nAMES treatment: The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles lengthened by the finger or wrist movements. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AMES Treatment', 'description': "The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.\n\nThe AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '13.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age at time of injury', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '14.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASIA Motor Key Muscles', 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '3.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measures the level of impairment of key muscles controlling the upper limb, including: elbow flexors (spinal level C5), wrist extensors (spinal level C6), elbow extensors (spinal level C7), finger flexors (spinal level C8), and finger abductors (spinal level T1). The scale range is 0 (total paralysis) to 5 (normal active movement), but also includes a scale category "NT," which indicates that muscle group was not testable. Total score is the sum of the scores from all 5 spinal levels ranging from 0-25. A higher score means less upper limb impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since injury', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Enrolled 13 subjects. Three subjects dropped out. Of the remaining 10 subjects, 15 limbs were tested, both limbs in 5 of the subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2009-01-29', 'resultsFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-03', 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grasp Release Test', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.'}], 'secondaryOutcomes': [{'measure': 'ASIA Motor Key Muscles', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'ISNCSCI Assessment of motor function (upper limb only). Scores on a scale ranging from 0 (i.e., total paralysis) - 5 (i.e., full range of motion) for each of 5 upper limb muscle groups. Total score represents the overall level of the upper limb impairment and represents the sum of the 5 scores from the 5 upper limb muscle groups. Accordingly, the total score has a range of 0-25, with 0 representing a completely paralyzed upper limb and 25 representing a normally functioning upper limb.'}, {'measure': 'ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': "Measures the subject's sensory perception, with eyes closed, of a light touch by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation."}, {'measure': 'ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': "Measures the subject's sensory perception, with eyes closed, of a light prick of a safety pin produced by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation."}, {'measure': 'Van Lieshout Hand Function Test for Tetraplegia- Short Version', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'Measures the functional movement in the upper limb of people with cervical spinal cord injury. The short version of this test includes a total of 10 different functional tasks to be performed by the subject with the upper limb. For example, one task is to reach and pick up a filled Coke bottle, set it down, and then replace it in its original position. Each task is scored on a scale of 0-5, 0 representing inability to perform the task and 5 representing normal movement. A single, total score is calculated as the sum of the scores on the 10 tasks, and therefore, has an overall range of 0-50, with higher scores representing better performance.'}, {'measure': 'Modified Ashworth Scale', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'Measurement of joint stiffness (tone/spasticity). Score is based on sum of MAS value for 4 muscle groups: (1) Wrist/finger flexors, (2) Wrist/finger extensors, (3) elbow flexors, and (4) elbow extensors. Each muscle group and direction is score on a scale of 0 (no increase in muscle tone) to 5 (rigid), with a score of 2 used instead of 1+. A single overall score representing the sum of all 4 muscle groups and directions is used and has a range of 0-20 with higher scores representing more severe impairment.'}, {'measure': 'Capabilities of Upper Extremity Instrument', 'timeFrame': 'Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training', 'description': 'Subjective questionnaire of participants\' self-perceptions of upper limb function that contains 17 questions relating to the use of the right upper limb, the same 17 relating to the use of the lower upper limb, plus two additional questions relating to bimanual function. Responses to each item of the questionnaire has a range of 1 (i.e., "totally limited") to 7 (i.e., "not at all limited"). A total cumulative score used for the study is based on the sum of the responses to all 34 questions (i.e., 16 right arm, 16 left arm, 2 both arms), and therefore has a cumulative score range of 32 - 224, with higher scores indicating more function.'}, {'measure': 'Strength Test - Thumb/Finger Extension', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum strength of thumb-and-fingers in extension.\n\nPre-training score is average of a total of 3 scores, including 1 score from each of the first 3 days of training. Post-training score is average of a total of 3 scores, including 1 score from each of the last 3 days of training.'}, {'measure': 'Strength Test - Thumb/Fingers Flexion', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum strength of Thumb/fingers in Flexion\n\nPre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.'}, {'measure': 'Strength Test - Wrist Extension', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum wrist strength in extension\n\nPre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.'}, {'measure': 'Strength Test - Wrist Flexion', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Maximum strength in flexion direction\n\nPre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.'}, {'measure': 'Active Motion Test - Fingers/Thumb', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Tracking task for the thumb and finger, i.e., opening and closing the hand. The participant tracks a target box on a video screen by actively moving the thumb and fingers, first in the opening direction, then closing, and finally opeining again. The participant\'s thumb-and-finger position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The "Pre-training Score" is the average score obtained during the first 3 days of training, and the Post-training Score" is average score obtained during the last 3 days of training.'}, {'measure': 'Active Motion Test - Wrist', 'timeFrame': 'Prior to training (baseline), after each of 25 training sessions (about 3 times/week)', 'description': 'Tracking task for the wrist, i.e., flexing (i.e., pull with the front of the hand) and extending (i.e., pushing with the back of the hand). The participant tracks a target box on a video screen by actively moving the hand at the wrist, first in the extension direction, then flexion, and finally extension again. The participant\'s wrist position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The "Pre-training Score" is the average score obtained during the first 3 days of training, and the Post-training Score" is average score obtained during the last 3 days of training.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Incomplete Spinal Cord Injury', 'Rehabilitation', 'Upper Extremity', 'AMES device', 'Incomplete SCI', 'Quadriplegia'], 'conditions': ['Spinal Cord Injury', 'Tetraplegia', 'Paresis', 'Plegia']}, 'referencesModule': {'references': [{'pmid': '18645190', 'type': 'RESULT', 'citation': 'Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.\n\nThe hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).', 'detailedDescription': 'Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.\n\nIn this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic SCI with tetraplegia.\n* Male or female.\n* 18-65 yrs old.\n* At least 1 yr post-SCI.\n* Tolerate sitting upright at for at least one hour.\n* Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested.\n* Motor grade \\>1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested.\n* Cognitively and behaviorally capable of complying with the regimen.\n\nExclusion Criteria:\n\n* Fracture of the treated limb resulting in loss of range of motion\n* Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study)\n* DVT of the treated extremity\n* Peripheral nerve injury of the treated extremity\n* Osteo- or rheumatoid-arthritis limiting range of motion\n* Contractures equal to or greater than 50% of the normal ROM\n* Skin condition not tolerant of device\n* Progressive neurodegenerative disorder\n* Botox treatment of the treated extremity in the prior 5 month\n* Chronic ITB therapy\n* Uncontrolled seizure disorder\n* Uncontrolled high blood pressure/angina\n* Pain in affected limb or exercise intolerance'}, 'identificationModule': {'nctId': 'NCT00833105', 'briefTitle': 'Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury', 'nctIdAliases': ['NCT00437515'], 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)', 'orgStudyIdInfo': {'id': '4649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMES treatment', 'description': 'The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.', 'interventionNames': ['Device: AMES treatment']}], 'interventions': [{'name': 'AMES treatment', 'type': 'DEVICE', 'description': "The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.", 'armGroupLabels': ['AMES treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '97006', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Paul J. Cordo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Deborah Backus, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shepherd Center, Atlanta GA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shepherd Center, Atlanta GA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Paul J. Cordo', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}