An Innovative Image-Based Method for Extensibility Assessment
April 22, 2025 updated by: Shaimaa Mohamed Ahmed Elsayeh, Cairo University
Revolutionizing Scar Evaluation: An Innovative Image-Based Method for Extensibility Assessment
This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
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
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Cairo
-
Cairo, New Cairo, Egypt, 02
- Shaimaa Mohamed Ahmed Elsayeh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Traditional physical therapy group
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:
|
Application of laser three times per week in addition to applying deep friction massage, stretching exercises along with the uses of pressure garment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vancouver Scar Scale (VSS)
Time Frame: Baseline and three months after the intervention
|
to evaluate vascularity, pigmentation, pliability, and scar height.
|
Baseline and three months after the intervention
|
|
Firmness and pliability at the scar site
Time Frame: Baseline and three months after the intervention
|
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
Time Frame: Baseline and three months after the intervention
|
the scar images before and after the intervention will go through three steps:
|
Baseline and three months after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shaimaa MA Elsayeh, PhD, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2024
Primary Completion (Estimated)
May 4, 2025
Study Completion (Estimated)
May 12, 2025
Study Registration Dates
First Submitted
April 16, 2025
First Submitted That Met QC Criteria
April 22, 2025
First Posted (Actual)
April 23, 2025
Study Record Updates
Last Update Posted (Actual)
April 23, 2025
Last Update Submitted That Met QC Criteria
April 22, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005678
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.