Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors
1 other identifier
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2026
Shorter than P25 for not_applicable stroke
2 active sites
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
First Submitted
Initial submission to the registry
July 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 29, 2026
CompletedStudy Start
First participant enrolled
August 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2027
Study Completion
Last participant's last visit for all outcomes
February 10, 2027
July 29, 2026
July 1, 2026
6 months
July 24, 2026
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
The assesment will be done at baseline and after completion of 8 weeks.
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.
The assesment will be done at baseline and after completion of 8 weeks.
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.
The assesment will be done at baseline and after completion of 8 weeks.
Study Arms (2)
Clinical Exercise group
ACTIVE COMPARATORParticipants in the Clinical Exercise-Based Group will receive standard physiotherapy in a clinical setting, including range-of-motion, strengthening, task-specific functional, and repetitive motor exercises for the affected upper limb. Sessions will be conducted 3 times per week for 45 minutes over 8 weeks following standardized clinical protocols.
m Health
EXPERIMENTALParticipants receive upper limb rehabilitation via a mobile app with structured exercises for range of motion, strengthening, and functional tasks targeting the shoulder, elbow, wrist, and hand to improve motor control and coordination. Sessions last 45 minutes, 3 times weekly for 8 weeks.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Subacute and chronic stroke patient \> 3 months post stroke. Modified Ashworth scale \<3 MOCA \> 24. An ability to understand the command First ever stroke Grade II, III, IV on Functional mobility Scale Able to use and comprehend smart phone.
You may not qualify if:
- Posterior circulation stroke. Vestibular disorders, paroxysmal vertigo Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome Presence of orthopedic diseases involving the upper limb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Services Hospital
Lahore, Punjab Province, 54000, Pakistan
Lahore University of Biological and Applied Sciences
Lahore, Punjab Province, Pakistan
Related Publications (2)
Malik AN, Afridi A, Rathore FA. Mobile Health (mHealth) Applications for Stroke Rehabilitation: A mini review. J Pak Med Assoc. 2024 Sep;74(9):1723-1726. doi: 10.47391/JPMA.24-74.
PMID: 39279090RESULTCao W, Li A, Kadir AA, Chen J, Chen L, Li Q, Hassan II. Older adult stroke survivors' needs and perspectives of a stroke app: a qualitative study. BMC Geriatr. 2025 Mar 29;25(1):212. doi: 10.1186/s12877-025-05849-1.
PMID: 40158132RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor will be kept blinded
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2026
First Posted
July 29, 2026
Study Start (Estimated)
August 15, 2026
Primary Completion (Estimated)
February 10, 2027
Study Completion (Estimated)
February 10, 2027
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share