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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2026-02-20

Brief Summary

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"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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Detailed Description

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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.

Conditions

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Ankle Sprains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Clinic

Group Type EXPERIMENTAL

Clinic

Intervention Type DIAGNOSTIC_TEST

group A will get treatment in clinic

Mobile App

Group Type EXPERIMENTAL

Mobile App

Intervention Type COMBINATION_PRODUCT

group B will use mobile application for treatment

Interventions

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Clinic

group A will get treatment in clinic

Intervention Type DIAGNOSTIC_TEST

Mobile App

group B will use mobile application for treatment

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No