- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07720609
TELE-REHABILITATION VERSUS CLINIC-BASED MODIFIED CONSTRAINT-INDUCED MOVEMENT THERAPY FOR UPPER LIMB FUNCTION IN CHRONIC STROKE PATIENTS (TELE-mCIMT)
Stroke commonly results in persistent upper limb impairment that limits functional independence and participation in daily activities. Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based intervention for improving upper limb function after stroke. Tele-rehabilitation has emerged as an alternative method of delivering rehabilitation services, potentially improving accessibility while maintaining treatment effectiveness.
This randomized controlled trial will compare the effectiveness of tele-rehabilitation-based mCIMT with clinic-based mCIMT in individuals with chronic stroke. Sixty-eight eligible participants will be randomly allocated into two groups. The tele-rehabilitation group will receive supervised mCIMT through virtual sessions combined with a structured home exercise program, while the clinic-based group will receive the same intervention in a clinical setting. Both groups will receive treatment three times per week for 6 weeks.
Upper limb function, spasticity, motor performance, and intrinsic motivation will be assessed at baseline and after the 6-week intervention using the Upper Extremity Fugl-Meyer Assessment (UEFMA), Modified Ashworth Scale (MAS), Wolf Motor Function Test (WMFT), and Intrinsic Motivation Inventory (IMI). The study aims to determine whether tele-rehabilitation is as effective as clinic-based mCIMT for improving upper limb function in individuals with chronic stroke.
Study Overview
Status
Conditions
Detailed Description
This study is a single-center, randomized controlled trial designed to compare the effectiveness of tele-rehabilitation-based modified Constraint-Induced Movement Therapy (mCIMT) with clinic-based mCIMT in individuals with chronic stroke. A total of 68 participants meeting the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and randomly allocated into two groups using the sealed envelope method. Outcome assessors will remain blinded to group allocation.
Participants in the tele-rehabilitation group will attend an initial in-person assessment followed by supervised virtual rehabilitation sessions. The intervention will include heat application, self-stretching, active-assisted range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy. Participants will perform functional upper limb activities while wearing a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Participants in the clinic-based group will receive the same rehabilitation components, including heat application, stretching, range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy, delivered face-to-face in the rehabilitation clinic. Treatment sessions will be conducted three times per week for 6 weeks, with home practice using the constraint mitt for 4 hours daily.
Outcome assessments will be performed at baseline and after completion of the 6-week intervention. The primary outcome measures will include upper limb motor function assessed using the Upper Extremity Fugl-Meyer Assessment (UEFMA) and spasticity assessed using the Modified Ashworth Scale (MAS). Secondary outcome measures will include the Wolf Motor Function Test (WMFT) and the Intrinsic Motivation Inventory (IMI). The study will evaluate whether tele-rehabilitation-based mCIMT provides comparable or superior improvements in upper limb function, motor performance, spasticity, and motivation compared with clinic-based mCIMT in individuals with chronic stroke.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Montiha Azeem, MSPTN
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
Study Contact Backup
- Name: Kainat Tariq, MSPTN
- Phone Number: 03328256500
- Email: kainattariq06@gmail.com
Study Locations
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Shadman Medical Center, Lahore
-
Contact:
- Montiha Azeem, MSPTN
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
-
Contact:
- Kainat Tariq, MSPT N
- Phone Number: 03328256500
- Email: kainattariq06@gmail.com
-
Principal Investigator:
- Kainat Tariq, MSPTN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant with age from 35 to 75 years
- Both gender
- Patients after 6 month of stroke.
- Participant with flexion and abduction at shoulder minimum 10-15 degree and 5-10 degree at wrist and thumb/digit.
- Participants with access to a smartphone or laptop with internet connectivity and the ability to use it for tele-rehabilitation sessions.
- Participant with modified ashworth scale score of 2 or higher.
- Participants who have internet access and can also engage in video conferences.
Exclusion Criteria:
- Patient with any neurological issues apart from stroke that might impact motor function.
- Patient who is not able to follow the commands or are unable to cooperate.
- Patient with any autoimmune disorder like rheumatoid arthritis that might impact arm function.
- Patient with history of epilepsy. Participant who are involved in any fitness program that can improve upper extremity function.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation.
The intervention will include supervised virtual sessions consisting of heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities.
Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Treatment will be provided 3 sessions per week for 6 weeks.
|
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation.
The intervention will include supervised virtual sessions comprising heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities.
Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.
Treatment will be delivered 3 sessions per week for 6 weeks.
|
|
Active Comparator: group B Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting.
The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision.
Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and for 4 hours daily at home.
Treatment will be provided 3 sessions per week for 6 weeks.
|
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting.
The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision.
Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and continue constraint use for 4 hours daily at home.
Treatment will be delivered 3 sessions per week for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Fugl-Meyer Assessment (UEFMA)
Time Frame: Baseline and Week 6
|
The Upper Extremity Fugl-Meyer Assessment (UEFMA) will be used to evaluate upper limb motor recovery.
Changes in UEFMA scores from baseline to the end of the 6-week intervention will be compared between the tele-rehabilitation and clinic-based modified Constraint-Induced Movement Therapy groups.
|
Baseline and Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kainat Tariq, MSPTN, The University of Lahore, Lahore
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
Keywords
Other Study ID Numbers
- UOL/IREB/25/09/0038
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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