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

N/AActive Not RecruitingNCT06905418

Superior University100 enrolled

Overview

"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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Ankle Sprains

Interventions

ClinicDIAGNOSTIC_TEST

group A will get treatment in clinic

Mobile AppCOMBINATION_PRODUCT

group B will use mobile application for treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Superior University

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Foot and Ankle Ability Measure (FAAM)

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

Time frame: 12 Months

Numeric pain rating scale (NPRS)

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

Time frame: 12 months

Data from ClinicalTrials.gov

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