NCT07803003

Brief Summary

This single-blinded randomized controlled trial aims to compare the effectiveness of maximum versus minimum therapist supervision during home-based telerehabilitation for improving upper limb motor function, task performance, coordination, and proprioception in stroke survivors. The study will be conducted at MDL Rehabilitation FUCP and participants' home settings. A total of 30 stroke survivors aged 40-70 years with mild to moderate upper limb impairment (Fugl-Meyer Assessment of the Upper Extremity \[FM-UE\] score 23-56) and a stroke duration of 3-24 months will be recruited through purposive sampling and randomly allocated to either the maximum- or minimum-supervision group.Participants in the maximum-supervision group will receive three 45-minute videoconference-based telerehabilitation sessions per week, for a total of 24 sessions over eight weeks. Exercises will be individualized according to baseline FM-UE scores. The minimum-supervision group will perform an independent home-based exercise program at the same frequency and duration, supplemented by weekly therapist check-ins and a self-maintained exercise log. Both groups will receive standardized instructional materials, including an exercise booklet and demonstration videos, and will perform exercises within individual fatigue limits.The primary outcomes will be assessed using the Fugl-Meyer Upper Extremity Assessment, Wolf Motor Function Test, Comprehensive Coordination Scale, and Thumb Localization Test, evaluating upper limb motor recovery, functional task performance, coordination, and proprioception.The study is expected to determine whether greater therapist supervision provides superior or comparable outcomes and to contribute evidence for developing effective, scalable, and cost-efficient home-based telerehabilitation models for stroke rehabilitation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 11, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2027

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

stroketelerehabilitationupper limbminimum supervision rehabmaximum supervision rehab

Outcome Measures

Primary Outcomes (4)

  • Coordination

    Comprehensive coordination scale will be used to asses upper limb coordination with higher scores indicating better coordination.

    8 Weeks

  • Upper-limb motor function

    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.

    8 Weeks

  • Upper limb task performance

    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.

    8 weeks

  • Proprioception

    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

Study Arms (2)

Group A - Maximum supervision telerehabilitation

EXPERIMENTAL

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.

Procedure: Maximum supervision telerehabilitation

Group B - Minimum supervision telerehabilitation

EXPERIMENTAL

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.

Procedure: Minimum Supervision Telerehabilitation

Interventions

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.

Group A - Maximum 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. 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.

Group B - Minimum supervision telerehabilitation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Tehreem Fatima, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 10, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08

Locations