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Active, not recruitingNCT06905418Updated Apr 1, 2025

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

An interventional study of Clinic and Mobile App in Ankle Sprains, sponsored by Superior University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Superior University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ankle Sprains
03

In context

Sprains and Strains

217 studies on the registry are indexed under Sprains and Strains; 44 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 166 interventional studies indexed under Sprains and Strains.

Browse Sprains and Strains studies →

Lead sponsor

Superior University is the lead sponsor of 242 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Clinic

    Diagnostic Test: Clinic

  • Experimental
    Mobile App

    Combination Product: Mobile App

Interventions

  • Diagnostic testClinic

    group A will get treatment in clinic

  • Combination productMobile App

    group B will use mobile application for treatment

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • Superior University
    Lahore, Punjab, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06905418
Lead sponsor
Superior University
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Apr 1, 2025
Start date
Mar 20, 2025
Primary completion
Jun 20, 2025 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Apr 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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