Effects of Maximum Versus Minimum Supervised Telerehabilitation on Upper Limb Function in Post Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This single-blinded randomized controlled trial will compare the effects of maximum versus minimum therapist supervision during home-based telerehabilitation in stroke survivors with upper limb impairment. The study will examine whether the intensity of therapist supervision influences improvements in upper limb motor function, functional task performance, coordination, and proprioception. The study will be conducted over one year at MDL Rehabilitation FUCP and in participants' home settings. With the increasing demand for accessible and home-based stroke rehabilitation, this study aims to determine whether frequent therapist supervision provides additional benefits or whether a less supervised model can achieve comparable functional recovery.
A total of 30 stroke survivors aged 40-70 years will be recruited through purposive sampling. Participants will have experienced a stroke 3-24 months before enrollment and will demonstrate mild to moderate upper limb impairment, defined by a Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score between 23 and 56. Eligible participants will undergo baseline assessment before being randomly allocated into either the maximum-supervision or minimum-supervision group. Randomization will help ensure an appropriate comparison between the two intervention approaches.
The rehabilitation intervention will be developed from a standardized pool of 50 pre-designed therapeutic exercises. This exercise pool will provide a structured range of activities addressing different components of upper limb recovery while allowing the program to be individualized according to each participant's baseline motor ability. Exercise selection and progression will be guided by the participant's initial FMA-UE performance and response to treatment. The intervention will follow a progressive sequence over the eight-week treatment period. During the first two weeks, exercises will primarily focus on range of motion (ROM), mobility, and controlled movement of the affected upper limb. As participants progress, the exercises will gradually incorporate more functional and challenging activities.
During weeks 3 and 4, the program will progress toward bimanual activities requiring coordinated use of both upper limbs. In weeks 5 and 6, greater emphasis will be placed on grasp-and-release activities to improve hand control, object manipulation, and functional use of the affected limb. During the final two weeks, exercises will advance toward fine motor activities requiring greater precision, dexterity, coordination, and selective hand movements. This staged progression from basic movement to increasingly complex functional activities is intended to provide an appropriate therapeutic challenge while supporting gradual improvement in motor control and task performance. Exercises will be selected from the established 50-exercise pool based on individual ability rather than applying an identical exercise sequence to every participant.
Participants in the maximum-supervision group will receive three 45-minute videoconference sessions per week for eight weeks, providing a total of 24 therapist-supervised sessions. During these sessions, the therapist will monitor exercise performance, provide verbal and visual feedback, correct compensatory movement patterns, and modify activities when appropriate. The therapist will also ensure that exercises remain suitable for the participant's functional level and fatigue tolerance. In contrast, participants in the minimum-supervision group will perform their prescribed 45-minute home exercise sessions independently three times per week for the same eight-week period. They will receive weekly therapist check-ins to review progress, address difficulties, and support adherence. Both groups will therefore complete an equivalent overall exercise schedule, while differing primarily in the amount of direct therapist supervision.
To maintain consistency between groups, all participants will receive the same exercise booklet and demonstration videos. They will be instructed to perform exercises within their individual fatigue limits and to follow the prescribed progression. Participants in the minimum-supervision group will maintain an exercise log to record their home practice, while therapist monitoring in the maximum-supervision group will provide more frequent oversight of exercise performance and adherence.
The effects of the intervention will be evaluated using established outcome measures. The Fugl-Meyer Upper Extremity Assessment will assess upper limb motor impairment and recovery. The Wolf Motor Function Test will evaluate functional task performance and upper limb use. Coordination will be assessed using the Comprehensive Coordination Scale, while proprioceptive function will be evaluated using the Thumb Localization Test. These measures will allow assessment of changes across motor recovery, functional performance, coordination, and sensory-motor control.
The study is expected to determine whether intensive therapist supervision results in superior outcomes compared with a minimally supervised home-based program. The findings may help establish an appropriate supervision model for telerehabilitation after stroke and support the development of practical, scalable, and cost-efficient rehabilitation programs that can provide structured upper limb training within the home environment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tehreem Fatima, DPT
- Phone Number: +923160515404
- Email: peelupaul4@gmail.com
Study Locations
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Islamabad, Pakistan
- Recruiting
- Foundation University College of Physical Therapy
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Contact:
- Muhammad Ehab Azim, PHD
- Phone Number: 642 051-5788171
- Email: ehab@fui.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stroke either ischemic or hemorrhagic clinically diagnosed or confirmed by MRI or CT.
- Stroke duration between 3 and 24 months.
- Age between 40 and 70 years.
- FMA score of 23-56 out of 66 points on the hemiplegic side.
- Mini mental state examination score greater than 24 out of 30.
- Ability to maintain stable sitting with or without support for at least 30-45 minutes
- No serious auditory, memory or visual impairment.
- Ability to read,understand and follow instructions in urdu.
- Access to a device with internet and video capabilities and basic ability to operate it.
- Availability of a caregiver or a family member to assist during sessions if required.
Exclusion Criteria:
- - Presence of aphasia or apraxia or unilateral neglect.
- Unable to understand or remember or follow commands.
- Modified ashworth scale score greater than 3 for spasticity.
- History of other brain diseases or brain surgery.
- Other causes of severe upper limb dysfunction.
- Unstable medical condition or vital organ failure including malignancy.
- Inability to cooperate with telerehabilitation procedures.
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: Group A - Maximum supervision telerehabilitation
Participants in the maximum-supervision group will receive three 45-minute videoconference sessions per week for eight weeks, providing a total of 24 therapist-supervised sessions.
During these sessions, the therapist will monitor exercise performance, provide verbal and visual feedback.
|
Participants in the maximum supervision group will receive physiotherapist-supervised home-based telerehabilitation comprising three 45-minute real-time videoconference sessions per week so 24 sessions over eight weeks.
An individualized upper limb exercise program will be prescribed from a standardized exercise pool based on each participant's baseline Fugl-Meyer Assessment-Upper Extremity score and functional abilities.
Exercises will progress from range of motion for week 1-2 to bimanual tasks for week 3-4 to grasp and release activities for week 5-6 and fine motor activities for week 7-8 with progression tailored to performance and performed within fatigue limits.
Participants will receive an exercise booklet and demonstration videos for support.
|
|
Experimental: Group B - Minimum supervision telerehabilitation
Participants in the minimum-supervision group will perform their prescribed 45-minute home exercise sessions independently three times per week for the same eight-week period.
They will receive weekly therapist check-ins to review progress, address difficulties, and support adherence.
|
Participants in the minimum-supervision group will perform their prescribed 45-minute home exercise sessions independently three times per week for the same eight-week period.
The individualized upper limb exercise program will be selected from a standardized exercise pool according to each participant's baseline Fugl-Meyer Assessment-Upper Extremity score and functional abilities.
Exercises will progress from range-of-motion activities during weeks 1-2, to bimanual tasks during weeks 3-4, grasp-and-release activities during weeks 5-6, and fine motor activities during weeks 7-8 with progression tailored to performance and performed within fatigue limits.
Participants will receive an exercise booklet and demonstration videos to facilitate independent exercise performance.
Physiotherapists will conduct weekly remote check-ins to monitor adherence, address difficulties, and provide guidance, while participants will maintain a self-reported exercise log.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Coordination
Time Frame: 8 Weeks
|
Comprehensive coordination scale will be used to asses upper limb coordination with higher scores indicating better coordination.
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8 Weeks
|
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Upper-limb motor function
Time Frame: 8 Weeks
|
Upper limb motor function refers to the ability of the affected upper extremity to perform voluntary, controlled, and coordinated movements following stroke.
It will be assessed using the Fugl-Meyer Assessment-Upper Extremity (FMA-UE).
Participants with baseline FMA-UE scores of 23-56 will be included, indicating mild to moderate upper limb impairment.
The FMA-UE will be measured at baseline (pre-intervention) and immediately after the 8-week intervention (post-intervention) to determine changes in motor function.
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8 Weeks
|
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Upper limb task performance
Time Frame: 8 weeks
|
Upper limb task performance refers to the ability of the affected upper extremity to perform functional movements and goal-directed tasks required for daily activities.
It will be assessed using the Wolf Motor Function Test (WMFT), which evaluates functional upper limb movements through standardized tasks.
Performance is scored on a 0-5 functional ability scale, with higher scores indicating better function, and task completion time is also recorded..
The WMFT will be measured at baseline (pre-intervention) and immediately after the 8-week intervention (post-intervention) to determine changes in upper limb task performance.
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8 weeks
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Proprioception
Time Frame: 8 Weeks
|
Proprioception refers to the ability to perceive the position and movement of the affected upper limb without relying on visual input.
It will be assessed using the Thumb Localization Test, which evaluates the participant's ability to accurately identify the position of the affected thumb.
It will be measured at baseline (pre-intervention) and immediately after the 8-week intervention (post-intervention) to determine changes in proprioceptive function.
|
8 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
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More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/FUCP/CTR/Neuro/Tehreem
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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