Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorLahore University of Biological and Applied Sciences

About this trial

impairments that limit functional independence. This study aims to develop and validate a bilingual (English and Urdu) mobile application to improve upper limb function in stroke survivors through structured, task-oriented exercises. It will be conducted in two phases: app development and validation, followed by a pilot randomized controlled trial. A total of 20 participants will be recruited using convenience sampling and randomly assigned to either a clinical exercise-based group or an app-based training group, with allocation concealment ensured through sealed envelopes. The study will follow a double-blinded design, where both participants and the outcome assessor will be blinded. Outcomes will be measured using the Wolf Motor Function Test (WMFT), Fugl- Meyer Assessment (FMA), and Nine Hole Peg Test (NHPT). The study aims to provide an accessible, evidence-based digital solution to enhance functional recovery and improve quality of life in stroke survivors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • mhealth

    Device

    Progressive Training Plan (8 Weeks) Phase I (Weeks 1-4): ROM \& Early Activation: * Passive, active-assisted, and active range of motion exercises for shoulder, elbow, wrist, and hand * Light strengthening with TheraBand and scapular stabilization * Basic task practice (reaching, grasping, releasing objects) Dose:2-3 sets of 8-10 reps (tasks: 10-15 reps), rest 60-90 sec Focus: Improve mobility, reduce stiffness, and activate muscles Phase II (Weeks 5-8): Strengthening \& Functional Training: * Progressive resistance training for upper limb muscles * Hand grip and pinch strengthening * Advanced functional tasks (pegboard, object transfer, ADL simulation, bilateral activities) Dose:3-4 sets of 12-15 reps (tasks: 20-30 reps), rest 60-90 sec Focus: Increase strength, coordination, endurance, and functional recovery

  • Routine Physical Therapy

    Other intervention

    Range-of-Motion Exercises: Include passive, active-assisted, and active movements of the shoulder, elbow, wrist, and fingers along with stretching to maintain joint mobility and reduce stiffness. Strengthening Exercises: Involve resisted upper limb exercises using TheraBands, weights, and therapy tools to improve shoulder, elbow, forearm, wrist, and hand strength, including grip and pinch strengthening. Task-Specific Functional Activities: Focus on functional and daily-life tasks such as reaching, grasping, object manipulation, pegboard tasks, ADL simulations, fine motor activities, and repetitive bilateral upper-limb training to enhance coordination and motor recovery.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Clinical Exercise groupActive comparator 1 intervention
Group B: m HealthExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Wolf Motor Function Test

The Wolf Motor Function Test (WMFT) is a standardized tool for assessing upper limb motor function in stroke survivors (Wolf et al., 2001). It includes 17 tasks: 15 timed functional activities (e.g., lifting objects, stacking) and 2 strength measures (grip and pinch). It evaluates movement speed, function, and quality, with performance rated on a 6-point scale (0-5) and faster times indicating better ability. The WMFT has high reliability (ICC \> 0.90) and strong validity, correlating well with FMA and ARAT.

Time frame
The assesment will be done at baseline and after completion of 8 weeks.
2

Fugl-Meyer Assessment - Upper Extremity

The Fugl-Meyer Assessment (FMA) is a widely used tool to measure motor impairment after stroke (Fugl-Meyer et al., 1975). It evaluates upper limb function including reflexes, coordination, and voluntary movement of the shoulder, elbow, wrist, and hand. The total score ranges up to 66, with higher scores indicating better motor recovery. Each item is scored from 0 to 2, and the sum reflects overall performance. It has excellent reliability (ICC \> 0.95) and strong validity for tracking motor recovery over time.

Time frame
The assesment will be done at baseline and after completion of 8 weeks.
3

Nine Hole Peg Test

The Nine-Hole Peg Test (NHPT) is a standardized, timed assessment used to measure fine motor dexterity of the upper limb (Mathiowetz et al., 1985). Participants place and remove nine pegs from a pegboard as quickly as possible, and performance is recorded in seconds. Lower completion time indicates better dexterity. It shows high reliability (ICC 0.88-0.99) and strong validity in stroke and other neurological conditions.

Time frame
The assesment will be done at baseline and after completion of 8 weeks.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: