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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
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.
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.
Shadman Medical Center, Lahore
Lahore, Punjab Province, Pakistan
RECRUITINGUpper Extremity Fugl-Meyer Assessment (UEFMA)
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.
Time frame: Baseline and Week 6
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