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

S

Superior University

Status

Active, not recruiting

Conditions

Ankle Sprains

Treatments

Combination Product: Mobile App
Diagnostic Test: Clinic

Study type

Interventional

Funder types

Other

Identifiers

NCT06905418
MSRSW/Batch-Fall23/782

Details and patient eligibility

About

"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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Clinic
Experimental group
Treatment:
Diagnostic Test: Clinic
Mobile App
Experimental group
Treatment:
Combination Product: Mobile App

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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