Effects of Conventional Outpatient Rehabilitation With and Without Adjunctive Telerehabilitation on Hand Function and Motor Recovery in Subacute Stroke Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Faisalabad
- Enrollment
- 48
- Locations
- 1
Study Overview
Brief Summary
Stroke is a leading cause of adult disability worldwide, with upper limb impairment significantly reducing independence. Traditional outpatient rehabilitation poses challenges for patients with mobility limitations, financial constraints, or those living in remote areas. This randomized controlled trial compares the effects of conventional outpatient rehabilitation with and without adjunctive telerehabilitation on hand function and motor recovery in subacute stroke patients. Forty-eight participants will be randomly assigned to two groups: Group A receives conventional outpatient rehabilitation plus home-based telerehabilitation via WhatsApp video calls (30 minutes daily, 5 days/week for 6 weeks), while Group B receives conventional outpatient rehabilitation alone (same dose and content). Outcome measures include the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Box and Block Test (BBT), and Physical Activity Enjoyment Scale (PACES), assessed at baseline and after 6 weeks.
Detailed Description
Stroke persists as the most prevalent cause of disability in adults worldwide, with upper limb disability significantly diminishing the level of independence in stroke survivors. Traditional post-stroke rehabilitation typically requires frequent visits to outpatient facilities, which can be inconvenient for patients with mobility impairments, those facing high transportation costs, or individuals living in remote areas. Telerehabilitation, delivered through digital communication platforms, offers a promising alternative that may expand access to rehabilitation services while maintaining treatment intensity and quality.
This study employs a randomized controlled trial design to investigate whether adding home-based telerehabilitation to conventional outpatient care produces superior outcomes compared to conventional care alone. The study will be conducted at three hospitals in Pakistan: Nusrat Fateh Ali Khan Hospital, Aziz Fatima Trust Hospital, and Madina Teaching Hospital. A total of 48 subacute stroke patients will be enrolled using convenience sampling, with sample size calculated using OpenEpi version 3 based on previous published data (Chen, 2020) with 95% confidence interval and 80% power.
Eligibility Criteria: Participants must have a Fugl-Meyer Assessment for Upper Extremity score between 22-56, a Box and Block Test score of at least 1 block in 60 seconds at screening, and no other major neurological or psychotic diseases, cognitive impairment, or pregnancy.
Randomization and Blinding: Participants will be randomly allocated using a computer-generated sequence. Allocation will be concealed, and outcome assessments will be performed by physiotherapists who remain blinded to group assignment.
Interventions: Both groups receive identical exercise content and dosage. Group A (Experimental) receives conventional outpatient rehabilitation plus home-based telerehabilitation via live WhatsApp video chats supervised by a physiotherapist. Each session lasts 30 minutes, five days per week for six weeks. During video sessions, the therapist observes participant setup, provides online verbal assistance, checks movement quality and safety, and modifies compensatory strategies. Participants receive essential equipment (small objects, balls, TheraBand) and an internet data bundle to support connectivity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcome assessors performing the Fugl-Meyer Assessment, Box and Block Test, and PACES evaluations will be blinded to group allocation. Participants and treating physiotherapists cannot be blinded due to the nature of the intervention.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subacute stroke patients (time since stroke: 1-6 months)\n
- •Fugl-Meyer Assessment for Upper Extremity score between 22-56\n
- •Box and Block Test score of at least 1 block in 60 seconds at the Screening Visit\n
- •Ability to provide informed consent\n
- •Access to a smartphone with WhatsApp capability (for Group A)
Exclusion Criteria
- •Any other major existing neurological or psychotic disease (e.g., Parkinson's disease, multiple sclerosis)\n
- •Pregnancy\n
- •Any disease apart from index stroke that noticeably affects arm function of paretic limb\n
- •Cognitive impairment that prevents understanding of instructions\n
- •Upper extremity acute orthopedic conditions\n
- •Medically unstable patients
Arms & Interventions
Telerehabilitation + Conventional Outpatient Rehabilitation
Participants receive conventional outpatient rehabilitation (on-site, 30 min/day, 5 days/week, 6 weeks) PLUS home-based telerehabilitation via WhatsApp video calls (same dose). Therapy includes warm-up/proximal activation exercises (shoulder shrugs, scapular retraction, trunk forward lean), task-oriented and strengthening exercises (reaching tasks, grasp and release, object transfers). Equipment includes small objects, balls, and TheraBand.
Intervention: Telerehabilitation with Conventional Therapy (Other)
Telerehabilitation + Conventional Outpatient Rehabilitation
Participants receive conventional outpatient rehabilitation (on-site, 30 min/day, 5 days/week, 6 weeks) PLUS home-based telerehabilitation via WhatsApp video calls (same dose). Therapy includes warm-up/proximal activation exercises (shoulder shrugs, scapular retraction, trunk forward lean), task-oriented and strengthening exercises (reaching tasks, grasp and release, object transfers). Equipment includes small objects, balls, and TheraBand.
Intervention: Conventional Outpatient Rehabilitation (Other)
Conventional Outpatient Rehabilitation Alone
Participants receive conventional outpatient rehabilitation only (on-site, 30 min/day, 5 days/week, 6 weeks). Therapy content is identical to the experimental group: warm-up/proximal activation exercises, task-oriented and strengthening exercises. A physiotherapist provides direct hands-on supervision, checks accuracy, and adjusts difficulty levels in real time based on participant progress.
Intervention: Conventional Outpatient Rehabilitation (Other)
Investigators
Anbreena Rasool
Assistant Professor, Department of Rehabilitation Sciences
University of Faisalabad