Design and Validation of a Mobile Health Application for... | NCT06905418

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

NCT06905418

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Apr 1, 2025Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Ankle Sprains

Interventions

Clinic
Mobile App

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2025Actual

Primary Completion Date

Jun 20, 2025Estimated

Completion Date

Feb 20, 2026Estimated

First Submitted Date

Mar 25, 2025

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Apr 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Apr 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clinic	Experimental		Diagnostic Test: Clinic
Mobile App	Experimental		Combination Product: Mobile App

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinic	Diagnostic Test	group A will get treatment in clinic	Clinic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Superior University		Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries