An Innovative Image-Based Method for Extensibility Assessment

Not Applicable

Active, not recruiting

• Conditions: Hypertrophic Scar

• Registration Number: NCT06940999
• Lead Sponsor: Cairo University

Brief Summary

This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.

Detailed Description

1. Quasi-experimental, single-group pre-post intervention:

Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method.

2. Methodological validation approach: The image-based method will be tested for:

* Reliability (test-retest, inter-rater)

* Validity (concurrent validity against established tools and construct validity)

Study Timeline

• Study Start: 2024-08-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-05-04
• Study Completion: 2025-05-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• History of clinically diagnosed scar contracture following thermal burns.
• Presence of scars (≥6 months post-burn) to ensure stability for accurate assessment.
• Scars located on functionally mobile areas (e.g., limbs) where extensibility impacts daily activities.
• Willingness to undergo a standardized physical therapy intervention.
• Ability to provide informed consent and comply with all study procedures.

Exclusion Criteria

• Active infection, unhealed wounds, or unstable scars at the assessment site.
• Diagnosed systemic diseases affecting collagen synthesis or wound healing (e.g., scleroderma, uncontrolled diabetes).
• History of experimental or non-standard scar treatment within the last 3 months.
• Severe cognitive impairments or communication barriers that interfere with understanding or participation.
• Pregnant or lactating women, due to hormonal influences on tissue healing and collagen metabolism.
• Concurrent participation in other physical therapy or rehabilitation studies targeting scar management.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vancouver Scar Scale (VSS)	Baseline and three months after the intervention	to evaluate vascularity, pigmentation, pliability, and scar height.
Firmness and pliability at the scar site	Baseline and three months after the intervention	Tonometry will be used to assess tissue firmness and pliability at the scar site.
Proposed Image-Based Method	Baseline and three months after the intervention	the scar images before and after the intervention will go through three steps: * Image Acquisition: High-resolution digital images of scars will be captured using a standardized protocol (fixed camera settings, lighting, distance).; * Image Preprocessing: Images will be converted to grayscale, and regions of interest (ROI) manually or automatically defined.; * Image Analysis: The standard deviation (STD) of pixel intensities within the ROI will be calculated as an indicator of tissue extensibility and collagen fiber cross-linking patterns will be detected and quantified using advanced image processing algorithms.

Trial Locations

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh; 🇪🇬 Cairo, New Cairo, Egypt