An Innovative Image-Based Method for Extensibility Assessment

NCT06940999 | Active Not Recruiting

• 1 other identifier: P.T.REC/012/005678
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertrophic Scar

Keywords

Image-based assessment; Scar extensibility assessment.

Outcome Measures

Primary Outcomes (3)

• Vancouver Scar Scale (VSS)

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

  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.

  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.

  Baseline and three months after the intervention

Study Arms (1)

Traditional physical therapy group

EXPERIMENTAL

This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach. 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. The image-based method will be tested for: * Reliability (test-retest, inter-rater) * Validity (concurrent validity against established tools and construct validity)

Other: Traditional physical therapy

Interventions

Traditional physical therapy OTHER

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

Traditional physical therapy group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaimaa MA Elsayeh, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: Mixed-method design combining quasi-experimental and instrument validation approaches

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: August 15, 2024
• Primary Completion: May 4, 2025
• Study Completion: May 12, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

EG (1)