Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain

"Ankle sprain is a common musculoskeletal injury that can pointedly influence the quality of life of an indivual. Old rehabilitation approaches often require recurrent clinic visits, which can be time-consuming, costly, and unreachable to many. This study aims to design and validate a mobile health application for home-based musculoskeletal therapy in ankle sprain.

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Key information

Conditions

Ankle Sprains Ankle Injuries Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Superior University

Lahore, Punjab Province, Pakistan

About this study

The study will employ a randomized controlled trial design, involving patients with ankle sprains, healthcare professionals, and healthy volunteers. The mobile health application will be designed to provide personalized exercises, education, and monitoring to improve rehabilitation outcomes. The study will evaluate the effects of the mobile health application (m Health) in reducing pain, improving functional ability, and ornamental quality of life. The study will also assess the usability and acceptability of the application among patients and healthcare professionals.

Outcome measurement tools will contain the Foot and Ankle Ability Measure (FAAM), Numeric Pain Rating Scale (NPRS) and System Usability Scale (SUS) The study will contribute to the development of an innovative, home-based rehabilitation solution for individuals with ankle sprains, improving accessibility and adherence to rehabilitation programs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults, 18-65 years, both gender(male and female) will be included.
Include participants clinically diagnosed with a lateral ankle sprain confirmed by a healthcare professional, with a clear timeframe such as within the last 4-6 weeks.
Grade I and II sprains (mild to moderate) will be included using NPRS tool range from 0 to 6.
Participants must own and be able to use a smartphone or tablet that is compatible with the mobile health application.
Specify that participants must be able to read and understand the application interface language.
Ensure participants can safely perform the exercises prescribed in the app without additional risk of injury

Exclusion criteria

Concurrent fractures of the leg or foot.
Previous surgery in the affected ankle or surgery resulting from the current ankle sprain.
Serious systemic illnesses (e.g. rheumatoid arthritis, or fibromyalgia).
Neurological impairments or other conditions that may affect rehabilitation outcomes

Treatment and study plan

Clinic

Diagnostic Test

group A will get treatment in clinic

Mobile App

Combination Product

group B will use mobile application for treatment

Primary outcomes

Foot and Ankle Ability Measure (FAAM)

Time frame: 12 Months

FAAM. Each item of the FAAM is scored on a 5-point Likert scale with 4 points representing no difficulty at all; 3 points, slight difficulty; 2 points, moderate difficulty; 1 point, extreme difficulty; and 0 points, unable to do
Numeric pain rating scale (NPRS)

Time frame: 12 months

The Numeric Pain Rating Scale (NPRS) is perhaps the most frequently applied scale used to quantify pain intensity in the clinical setting. It is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Apr 1, 2025
Registry last updated: Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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