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

NCT06905418 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/782
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Study Arms (2)

Clinic

EXPERIMENTAL

Diagnostic Test: Clinic

Mobile App

EXPERIMENTAL

Combination Product: Mobile App

Interventions

Clinic DIAGNOSTIC_TEST

group A will get treatment in clinic

Clinic

Mobile App COMBINATION_PRODUCT

group B will use mobile application for treatment

Mobile App

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)