Revolutionizing Scar Evaluation: An Innovative Image-Based Method for Extensibility Assessment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vancouver Scar Scale (VSS)
研究概览
简要总结
This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.
详细描述
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Traditional physical therapy (Other)
结局指标
主要结局
Vancouver Scar Scale (VSS)
时间窗: Baseline and three months after the intervention
to evaluate vascularity, pigmentation, pliability, and scar height.
Firmness and pliability at the scar site
时间窗: Baseline and three months after the intervention
Tonometry will be used to assess tissue firmness and pliability at the scar site.
Proposed Image-Based Method
时间窗: Baseline and three months after the intervention
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.
次要结局
未报告次要终点
研究者
Shaimaa Mohamed Ahmed Elsayeh
Asst. Prof. Dr.
Cairo University