Clinical trial NCT06905418: Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain
Official title: Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Sprains
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 12 Months
measure: Numeric pain rating scale (NPRS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Superior University
state: Punjab
Study officials:
References: