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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Routine Physical Therapy; Device: mhealth

Detailed Description

Stroke is a leading cause of long-term disability, often resulting in significant upper limb impairments that affect motor ability, coordination, and independence in daily activities. This study aims to develop and validate a bilingual (English and Urdu) mobile application designed to improve upper limb function in stroke survivors through structured, task-oriented rehabilitation exercises. The application will provide an accessible platform for home-based therapy, promoting patient engagement, continuous monitoring, and functional recovery. The study will be conducted in two phases: the first phase will focus on the development and validation of the mobile application, while the second phase will involve a pilot randomized controlled trial to evaluate its usability and effectiveness. A total of 20 stroke patients will be recruited using a convenience sampling technique. After initial screening, participants will be randomly allocated into two groups: a clinical exercise-based group and an app-based upper extremity training group using an online randomization tool. Allocation concealment will be ensured through the sealed envelope method to minimize selection bias. The study will follow a double-blinded design, where both participants and the outcome assessor will be blinded; the assessor will remain unaware of group allocation, and participants will be blinded to the study hypothesis. The effectiveness of the intervention will be evaluated using standardized outcome measures, including the Wolf Motor Function Test (WMFT) to assess motor ability, the Fugl-Meyer Assessment (FMA) to evaluate motor impairment, and the Nine Hole Peg Test (NHPT) to measure fine motor dexterity. By integrating evidence-based rehabilitation with a bilingual digital platform, this study aims to provide a comprehensive and accessible intervention that can enhance functional outcomes, promote independence in daily activities, and improve the overall quality of life for stroke survivors.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haziqa Pari, MSNMPT; Phone Number: +923044516865; Email: haziqamalik44@gmail.com
• Study Contact Backup: Name: Aruba Saeed, Supervisor; Phone Number: +92 334 4399403; Email: aruba.saeed@ubas.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Lahore University of Biological and Applied Sciences
      • Contact: Aruba Saeed, PhD; Phone Number: 0334 4399403; Email: arubasaeedpt@gmail.com
    • Lahore, Punjab Province, Pakistan, 54000
      • Services Hospital
      • Contact: Aruba Saeed, Phd; Phone Number: 0334 4399403; Email: arubaseed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical Exercise group; Participants 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.	Other: Routine Physical Therapy; 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.
Experimental: m Health; Participants 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.	Device: mhealth; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Lahore University of Biological and Applied Sciences

Publications and helpful links

General Publications

• 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.
• Cao 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2027

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: stroke rehabilitation; Mobile application; Stroke survivors; personalized interventions; Stroke rehabilitation for upper limb; technology integration
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: UBAS/ERB/26/04/036 Haziqa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No