CClinicalTrials.gg
Active, not recruitingNCT06940999Updated Apr 23, 2025

An Innovative Image-Based Method for Extensibility Assessment

An interventional study of Traditional physical therapy in Hypertrophic Scar, sponsored by Cairo University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-23.

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
  • Registered 8 months after the study started (first participant enrolled Aug 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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)
02

Conditions studied

  • Hypertrophic Scar

Keywords

  • Image-based assessment
  • Scar extensibility assessment.
03

In context

Cicatrix, Hypertrophic

121 studies on the registry are indexed under Cicatrix, Hypertrophic; 29 are open to participants now.

This study's enrollment of 90 is above the median of 36 across 104 interventional studies indexed under Cicatrix, Hypertrophic.

Browse Cicatrix, Hypertrophic studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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: * Reliability (test-retest, inter-rater) * Validity (concurrent validity against established tools and construct validity)

    Other: Traditional physical therapy

Interventions

  • OtherTraditional physical therapy

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

06

What researchers measure

Primary outcomes

  1. Vancouver Scar Scale (VSS)

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

    Time frame: Baseline and three months after the intervention

  2. 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

  3. 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

07

Study locations

1 site
  • Shaimaa Mohamed Ahmed Elsayeh
    Cairo, New Cairo 02, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06940999
Lead sponsor
Cairo University
Responsible party
Shaimaa Mohamed Ahmed Elsayeh (Asst. Prof. Dr., Cairo University) — Principal investigator
First posted
Apr 23, 2025
Start date
Aug 15, 2024
Primary completion
May 4, 2025 (estimated)
Completion
May 12, 2025 (estimated)
Last update
Apr 23, 2025

Study contacts

Shaimaa MA Elsayeh, PhD
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion