Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-31 @ 1:42 AM
Study NCT ID:
NCT06975904
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Control', 'timeFrame': '6 weeks', 'description': 'Fugl-Meyer Assessment for Lower Extremity (FMA-LE) is a standardized, stroke-specific tool designed to evaluate motor control. It demonstrates excellent reliability (ICC ≥ 0.98) and strong construct validity.'}, {'measure': 'Mobility', 'timeFrame': '6 weeks', 'description': 'Time Up and Go test: This test will be used to measure mobility in older adults.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke rehabilitation', 'Hemiplegia therapy', 'Motor activity', 'Gait physiology', 'Neuroplasticity', 'Movement disorders rehabilitation', 'Constraint-Induced Movement Therapy', 'Virtual reality therapy', 'Lower extremity pathophysiology'], 'conditions': ['Post Stroke', 'Mobility', 'Balance']}, 'descriptionModule': {'briefSummary': 'This study investigates the effectiveness of combining m-CIMT and VR to improve mobility in post-stroke patients. A non-blinded randomized controlled trial will be conducted with 32 participants divided equally into experimental and control groups using purposive sampling. The experimental group will receive m-CIMT with VR training, while the control group will receive m-CIMT with Task-Specific Functional Training. Sessions will be 30 minutes per day, 4 days a week, for 6 weeks. Outcomes will be measured using FMA-LE, BBS, DGI, TUG, and SS-QOL. The study will take place over one year at FFH and FUCP, with ethical approval from ERC FUMC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sample Selection Criteria\n\nInclusion Criteria\n\n* Sub-acute and chronic stroke patient \\>3months\n* Males and females of 40-60 years.\n* Mini-Mental State Examination score ≥24\n* FAC Scale = 3\n* Limited spasticity (0,1,1⁺) according to modified Ashworth scale\n* Adequate balance and walking ability while wearing the constraint to be eligible to participate in CIMT intervention.\n\nExclusion Criteria\n\n* Patient with Severe Spasticity and pain\n* Patient of Epilepsy, Parkinson's disease and stage 4 arthritis\n* Patient with Global Aphasia\n* Individuals suffering from unstable angina, symptomatic heart failure, or uncontrolled hypertension\n* Patients with any traumatic musculoskeletal injury and surgery of lower limb"}, 'identificationModule': {'nctId': 'NCT06975904', 'briefTitle': 'Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'FUI/CTR/2024/72'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'm-CIMT with Task-Specific Functional Training', 'description': 'Begin with low-intensity exercises and progress to moderate to high intensity; session will be for about 30 minutes Warm-up for 5 minutes;one minute of rest for every five minutes of exercise For week 1-3: Assisted standing and weight shifting, Heel raises, Toe taps, Supported stepping, Unassisted standing and balance tasks will be used For week 4-6: Progressive stepping exercises, Heel-to-toe standing, Unassisted balance and coordination tasks, Advanced stepping patterns and dynamic balance challenges, Functional tasks like step-ups and lateral steps will be used 5 minutes will be given for cool down', 'interventionNames': ['Procedure: m-CIMT with Task-Specific Functional Training']}, {'type': 'EXPERIMENTAL', 'label': 'm-CIMT with VR exer-games by Kinect Xbox 360', 'description': 'Virtual reality workout session will be for about 30 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For week 1-3: Soccer and Space Bubble Pop games will be used For week 4-6: 20,000 Leaks and Rally Ball games will be used 5 minutes will be given for cool down.', 'interventionNames': ['Procedure: m-CIMT with VR exer-games by Kinect Xbox 360']}], 'interventions': [{'name': 'm-CIMT with VR exer-games by Kinect Xbox 360', 'type': 'PROCEDURE', 'description': 'Virtual reality workout session will be for about 30 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For week 1-3: Soccer and Space Bubble Pop games will be used For week 4-6: 20,000 Leaks and Rally Ball games will be used 5 minutes will be given for cool down.', 'armGroupLabels': ['m-CIMT with VR exer-games by Kinect Xbox 360']}, {'name': 'm-CIMT with Task-Specific Functional Training', 'type': 'PROCEDURE', 'description': 'Begin with low-intensity exercises and progress to moderate to high intensity; session will be for about 30 minutes Warm-up for 5 minutes;one minute of rest for every five minutes of exercise For week 1-3: Assisted standing and weight shifting, Heel raises, Toe taps, Supported stepping, Unassisted standing and balance tasks will be used For week 4-6: Progressive stepping exercises, Heel-to-toe standing,', 'armGroupLabels': ['m-CIMT with Task-Specific Functional Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Foundation University College of Physical Therapy', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}