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

Not Applicable

Active, not recruiting

• Conditions: Ankle Sprains

• Registration Number: NCT06905418
• Lead Sponsor: Superior University

Brief Summary

"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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Foot and Ankle Ability Measure (FAAM)	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)	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

Trial Locations

Locations (1)

Superior University; 🇵🇰 Lahore, Punjab, Pakistan