An Innovative Image-Based Method for Extensibility Assessment

N/AActive Not RecruitingNCT06940999

Cairo University90 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypertrophic Scar

Interventions

Traditional physical therapyOTHER

Application of laser three times per week in addition to applying deep friction massage, stretching exercises along with the uses of pressure garment.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

Outcomes

Primary Outcomes

Vancouver Scar Scale (VSS)

to evaluate vascularity, pigmentation, pliability, and scar height.

Time frame: Baseline and three months after the intervention

Firmness and pliability at the scar site

Tonometry will be used to assess tissue firmness and pliability at the scar site.

Time frame: Baseline and three months after the intervention

Proposed Image-Based Method

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.

Time frame: Baseline and three months after the intervention

Data from ClinicalTrials.gov

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