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

Overview

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.

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.

Interventions

• 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:
• 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 re

Primary outcome measures

• Wolf Motor Function Test [Time frame: The assesment will be done at baseline and after completion of 8 weeks.]
• Fugl-Meyer Assessment - Upper Extremity [Time frame: The assesment will be done at baseline and after completion of 8 weeks.]
• Nine Hole Peg Test [Time frame: The assesment will be done at baseline and after completion of 8 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Pakistan · 2 centers

• Services Hospital — Lahore
• Lahore University of Biological and Applied Sciences — Lahore

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. PMID 39279090
• 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. PMID 40158132

Identifiers

NCT: NCT07734818 · UBAS/ERB/26/04/036 Haziqa

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗