- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604181
Comparative Effects of Telerehabilitation and Clinic Based Constraint Induced Movement Therapy on Upper Limb Function in Sub-Acute Stroke Patients
Stroke constitutes a principal cause of chronic neurological disability globally, frequently precipitating profound upper limb motor impairment that compromises functional autonomy and overall quality of life. Constraint-Induced Movement Therapy (CIMT) represents a rigorously validated neurorehabilitation paradigm grounded in the doctrine of experience-dependent neuroplasticity, promoting cortical reorganization through enforced utilization of the paretic limb while restraining the unaffected extremity. By counteracting learned non-use and emphasizing high- intensity, task-specific training, CIMT substantially augments motor recovery and functional performance. The primary objective of the present study is to comparatively evaluate the efficacy of CIMT delivery-clinic-based rehabilitation and telerehabilitation-in individuals with stroke. A total of 28 participants will be recruited through a non-probability consecutive sampling technique in accordance with explicitly defined inclusion and exclusion criteria, and will subsequently be randomized into two equal groups (n = 14 per group) using the chit-and-draw method to ensure unbiased allocation. Group A will receive CIMT within a clinical setting under direct supervision, whereas Group B will undergo an equivalent intervention via a structured online telerehabilitation platform under complete supervision. The intervention will be administered to both groups for duration of eight weeks. Outcome measures will include the Action Research Arm Test (ARAT), the Wolf Motor Function Test (WMFT), and the Modified Ashworth Scale (MAS) to comprehensively evaluate upper limb motor function and spasticity. Assessments will be conducted at baseline and at the completion of the eight-week intervention period.
Statistical analysis will be performed using SPSS version 23.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lieza Iftikhar
- Phone Number: +923000649149
- Email: liezaiftikhar.dpt@tuf.edu.pk
Study Contact Backup
- Name: Zahra Khadim
- Phone Number: 0330 1980604
- Email: drzahrakhadim@gmail.com
Study Locations
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 38000
- Recruiting
- Madinah Teaching Hospital
-
Contact:
- Lieza Iftikhar
- Phone Number: +923000649149
- Email: liezaiftikhar.dpt@tuf.edu.pk
-
Contact:
- Zahra Khadim
- Phone Number: 0330 1980604
- Email: drzahrakhadim@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed cases of ischemic or hemorrhagic stroke. 2. Age between 40-70 years. 3. Both male and female. 4. Presented with stroke for once in a life and in a period of 6 months post stroke.
5. Patient should not have any history of rehabilitation in his/her 6 months post stroke period. 6. Medically stable condition. 7. Ability to understand and follow simple verbal instructions. 8. Minimum active wrist and finger extension required to participate in CIMT.
Exclusion Criteria:
Severe cognitive impairment. 2. Severe spasticity (Modified Ashworth Scale score >3). 3. Other neurological or musculoskeletal disorders affecting upper limb function.
4. Severe aphasia limiting effective communication. 5. Any other musculoskeletal deficits interfering with task performance. 6. Uncontrolled systemic medical conditions. 7. No attendant's support the session. 8. Depression that restrains participant to cooperate during the session.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Constraint-Induced Movement Therapy within a clinical setting
|
it is clinic based treatment which includes Restraining the unaffected upper limb using a mitt or sling for approximately 5-6 hours per day to discourage learned non-use.
Intensive, task-specific training of the affected upper limb focusing on functional activities such as reaching, grasping, lifting, gripping, pinching, and object manipulation.
|
|
Experimental: Constraint-Induced Movement Therapy Via Telerehabilitation
|
Online Structured Tele Rehabilitation based treatment which includes Restraining the unaffected upper limb using a mitt or sling for approximately 5-6 hours per day to discourage learned non-use.
Intensive, task-specific training of the affected upper limb focusing on functional activities such as reaching, grasping, lifting, gripping, pinching, and object manipulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Wolf motor function test
Time Frame: 8 weeks
|
8 weeks
|
|
Action research arm test
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUF/EIRB/173/26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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