Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 9:10 PM
Study NCT ID:
NCT05570461
Status:
UNKNOWN
Last Update Posted:
2022-10-06
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wolf Motor function test', 'timeFrame': '4weeks', 'description': 'Use mainly for post-stroke patients with impaired upper limb motor ability. The purpose of this test is to enumerate upper limb motor ability through a series of functional tasks. The WMFT is an instrument with high internal consistency, interrater reliability and test-retest reliability. The quality of movement during the task is measured by functional ability scale, a 6-point ordinal scale, where 0 = does not attempt with the impaired arm and 5 = arm movement appear to be normal.\n\nHigher the value higher will be the normal function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This RCT will also help the clinicians to provide the best treatment to their patients for better outcomes.\n\nThe objective of the study is to determine the efficacy of Modified Constraint-induced movement therapy on the Upper Limb function of Sub-acute stroke patients in Peshawar Pakistan.\n\nAlternative Hypothesis: There will be a difference in the means of Modified Constraint-induced movement therapyand traditional physical therapy on the upper limb function of subacute stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Age 30 to 60 years\n* 2\\. Both female \\& male will be included.\n* 3\\. Cognitive and lingual ability to communicate with the research staff.\n* 4\\. A minimum of 10 degrees of active finger extension and 20 degrees of active wrist extension(16).\n* 5\\. A history of a single stroke resulting in a hemiparesis\n\nExclusion Criteria:\n\n* 1\\. Recurrent stroke during the training period.\n* 2\\. Neurological or orthopedic disorders prohibiting the use of the paretic arm.\n* 3\\. Patients who doesn't show willingness to participate in the study."}, 'identificationModule': {'nctId': 'NCT05570461', 'briefTitle': 'Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'NCS University System'}, 'officialTitle': 'Efficacy of Modified Constraint-Induced Movement Therapy on the Upper Limb Function of Sub-acute Stroke Patients in Peshawar Pakistan: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KMU/IPMR/MS/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Experimental group will receive Modified Constraint-Induced Movement Therapy and traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the Modified Constraint-Induced Movement Therapy group will be constrained by wearing a mitten during the treatment session', 'interventionNames': ['Other: Modified Constraint-Induced Movement Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Control group therapy will consist of increasing upper limb function with the use of both hands. The session include active or active assistive range of motion exercises, unilateral and bimanual activities, balance and strength training or coordination exercises depending on the severity of motor impairment. Similar to group A, daily therapy will be conducted for 40 min/day, 6 days/ week for upto 2 weeks.', 'interventionNames': ['Other: Modified Constraint-Induced Movement Therapy']}], 'interventions': [{'name': 'Modified Constraint-Induced Movement Therapy', 'type': 'OTHER', 'description': 'Experimental group will receive Modified Constraint-Induced Movement Therapyand traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the mCIMT group will be constrained by wearing a mitten during the treatment session and for 3 hours/day outside the therapy hours, 6(six) days/week for two weeks by an experienced Physical therapist.The time duration for Group A will be 40 minutes.', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCS University System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invistigator', 'investigatorFullName': 'Dr. Hazrat Bilal PT', 'investigatorAffiliation': 'Khyber Medical University Peshawar'}}}}