Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-23 @ 4:15 PM
Study NCT ID:
NCT06548295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barthal index', 'timeFrame': '12 Months', 'description': 'Barthel Index (BI) stands out as a widely utilized measure for assessing basic activities of daily living (ADL). Scores of 0-20 indicate "total" dependency. Scores of 21-60 indicate "severe" dependency. Scores of 61-90 indicate "moderate" dependency.'}, {'measure': 'The use of FMA-UE', 'timeFrame': '12 months', 'description': 'measureing comprising 30 items for motor function and 3 items for reflex function, provides a comprehensive evaluation of motor abilities .\n\nIn regards to UE feature, 33 elements evaluate motor function, six items assess sensitivity and proprioception, while the last 24 points rate joint pain and mobility.\n\nEvery item of the assessment scale is marked on an ordinal level, from 0 to 2; the 0 value corresponds with the impossibility to perform a movement, and 2 represents the ability to perform a complete and adequate movement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Stroke']}, 'descriptionModule': {'briefSummary': '"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.', 'detailedDescription': 'Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points. This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants will be under the age of 40-75 years\n* Diagnosis: stroke\n\nExclusion Criteria:\n\n* patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease\n* Balance problem\n* Rheumatic diseases\n* High spasticity"}, 'identificationModule': {'nctId': 'NCT06548295', 'briefTitle': 'Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Effects of Modified Constraint Induced Movement Therapy (mCIMT) Versus Conservative Treatment on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'modified constraint induced movement therapy (mCIMT)', 'interventionNames': ['Behavioral: modified constraint induced movement therapy (mCIMT)']}, {'type': 'EXPERIMENTAL', 'label': 'conservative treatment', 'interventionNames': ['Combination Product: conservative treatment']}], 'interventions': [{'name': 'modified constraint induced movement therapy (mCIMT)', 'type': 'BEHAVIORAL', 'description': 'Restraint the involved extremity by using a mitten. Repetitive task practice i.e filling a glass, drinking a glass of water, and eating with a spoon , stacking cones and stacking blocks, grasping and releasing of an object, reaching forward and sideways, lifting and dropping of an object from the one end of table to the other end.\n\nThe shaping exercises included cube stacking, card turning, throwing balls into a box, grasping/holding and placing objects of different sizes, and drawing and painting exercises. Intervention: 5 sessions per week for 50 minutes for 6 weeks', 'armGroupLabels': ['modified constraint induced movement therapy (mCIMT)']}, {'name': 'conservative treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'The conservative rehabilitation program consisted of upper-limb range of motion exercises, positioning, stretching, and strengthening exercises, Passive mobilization of the shoulder ,elbow , wrist and small joints of hand Stretching of the affected arm including biceps, triceps and muscles of forearm and hand.\n\nStrengthening exercises of upper arm and forearm muscles involved. Intervention: 5 sessions per week for six weeks and 50 mintues', 'armGroupLabels': ['conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sialkot', 'country': 'Pakistan', 'facility': 'Little angles home aziz bhati shaheed road opposit junior aps', 'geoPoint': {'lat': 32.49268, 'lon': 74.53134}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}