NCT07666906

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

January 19, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 18, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

TelerehabilitationStroke RehabilitationHand FunctionMotor RecoverySubacute Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Upper Extremity Motor Function

    Measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). The FMA-UE is a stroke-specific, performance-based impairment index. It assesses motor functioning of the upper extremity. Scores range from 0 to 66, with higher scores indicating better motor function.

    Baseline (pre-intervention) and 6 weeks (post-intervention)

Secondary Outcomes (2)

  • Change in Manual Dexterity

    Baseline (pre-intervention) and 6 weeks (post-intervention)

  • Change in Physical Activity Enjoyment

    Baseline (pre-intervention) and 6 weeks (post-intervention)

Study Arms (2)

Telerehabilitation + Conventional Outpatient Rehabilitation

EXPERIMENTAL

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.

Other: Telerehabilitation with Conventional TherapyOther: Conventional Outpatient Rehabilitation

Conventional Outpatient Rehabilitation Alone

ACTIVE COMPARATOR

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.

Other: Conventional Outpatient Rehabilitation

Interventions

Conventional outpatient rehabilitation is delivered on-site at neuro-physiotherapy outpatient departments of participating hospitals. Sessions run 30 minutes each, five days per week for six weeks, using the same exercise content, dosage, and progression criteria as the telerehabilitation group. Exercise components include: warm-up and proximal activation (shoulder shrugs, scapular retraction, trunk forward lean weight bearing) for 5 minutes, followed by task-oriented and strengthening exercises (reaching tasks, grasp and release, transfer of objects) for 20 minutes. A physiotherapist provides direct hands-on supervision, checks movement accuracy, and adjusts difficulty levels in real-time based on participant progress.

Conventional Outpatient Rehabilitation AloneTelerehabilitation + Conventional Outpatient Rehabilitation

Telerehabilitation is delivered via live WhatsApp video chats supervised by a physiotherapist. Each session lasts 30 minutes, five days per week for six weeks. 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. The therapy protocol is standardized using the Upper Extremity Task Specific Training after Stroke by Lang and Birkenmeier and the Accelerated Skill Attainment Program (Cramer et al., 2019).

Telerehabilitation + Conventional Outpatient Rehabilitation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

StrokeParesis

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 24, 2026

Study Start

January 19, 2026

Primary Completion

July 15, 2026

Study Completion

July 28, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations