Skip to content

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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06905418
Enrollment
100
Registered
2025-04-01
Start date
2025-03-20
Completion date
2026-02-20
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

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.

Interventions

DIAGNOSTIC_TESTClinic

group A will get treatment in clinic

COMBINATION_PRODUCTMobile App

group B will use mobile application for treatment

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Foot and Ankle Ability Measure (FAAM)12 MonthsFAAM. 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 monthsThe 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026