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

March 25, 2025 updated by: Muhammad Naveed Babur, Superior University
"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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Superior University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinic
Diagnostic test: Clinic
group A will get treatment in clinic
Experimental: Mobile App
Combination product: Mobile App
group B will use mobile application for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall23/782

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankle Sprains

Clinical Trials on Clinic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe