An Innovative Image-Based Method for Extensibility Assessment

Cairo University (CU)

Status: Active, not recruiting

Conditions: Hypertrophic Scar

Treatments: Other: Traditional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06940999

P.T.REC/012/005678

Details and patient eligibility

About

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

Full 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)

Enrollment: 90 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Traditional physical therapy group

Experimental group

Description:

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)

Treatment:

Other: Traditional physical therapy