Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:13 PM
Study NCT ID:
NCT04873908
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2021-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Modified Constraint-Induced on Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer assessment test', 'timeFrame': 'Score change after 6 weeks of intervention compared to baseline', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm'}, {'measure': 'Action Research arm test', 'timeFrame': 'Score change after 6 weeks of intervention compared to baseline', 'description': 'The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm'}, {'measure': 'Motor Activity Log', 'timeFrame': 'Score change after 6 weeks of intervention compared to baseline', 'description': 'Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale', 'timeFrame': 'Score change after 6 weeks of intervention compared to baseline', 'description': 'Modified Ashworth Scale was measure muscle spasticity. It is among the most commonly used scales for clinical and research purposes. The resistance against passive movement is evaluated on a scale of 0-4 points.The lower total score means better spasticity in the arm'}, {'measure': 'thumb localizing test', 'timeFrame': 'Score change after 6 weeks of intervention compared to baseline', 'description': "A proprioception examination, called the 'thumb localizing test' (TLT), is described as a technique for testing 'limb localization'. With the patient's eyes closed, the examiner positions one of the patient's upper limbs (fixed limb) and asks him to pinch the thumb of that limb with the opposite thumb and index finger (reaching limb).It is evaluated on a 0-3 point scale. The lower the total score, the better the proprioceptive in the arm."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Modified constraint-induced therapy', 'Proprioceptive Training', 'conventional rehabilitation'], 'conditions': ['Stroke', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post stroke hemiparetic patients of six months\n* spasticity ≤ Grade -3 on modified Ashworth scale\n* those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint\n* a score of 24 or higher on the Modified Mini-Mental State Examination\n* no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale\n\nExclusion Criteria:\n\n* Patients with history of previous stroke,\n* angina,\n* uncontrolled hypertension, on medication that could impair neuromuscular performance,\n* wrist or finger pathologies, significant visual or hearing impairment,\n* balance problems which may compromise safety during sound upper limb constraint,\n* unwilling to participate'}, 'identificationModule': {'nctId': 'NCT04873908', 'briefTitle': 'Effects of Modified Constraint-Induced on Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2020-24/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'conventional rehabilitation', 'interventionNames': ['Other: conventional rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Modified constraint-induced therapy', 'interventionNames': ['Other: modified constraint-induced therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Proprioceptive Training', 'interventionNames': ['Other: Proprioceptive Training']}], 'interventions': [{'name': 'modified constraint-induced therapy', 'type': 'OTHER', 'description': 'Patients received conventional rehabilitation and modified constraint-induced therapy schedule', 'armGroupLabels': ['Modified constraint-induced therapy']}, {'name': 'Proprioceptive Training', 'type': 'OTHER', 'description': 'Patients received conventional rehabilitation and Proprioceptive Training schedule', 'armGroupLabels': ['Proprioceptive Training']}, {'name': 'conventional rehabilitation', 'type': 'OTHER', 'description': 'Patients received conventional rehabilitation schedule', 'armGroupLabels': ['conventional rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34752', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assit Prof. Nuray Alaca', 'investigatorFullName': 'Nuray Alaca', 'investigatorAffiliation': 'Acibadem University'}}}}