跳至主要内容
临床试验/NCT05425433
NCT05425433已完成不适用

Should Serial Casting be a "First-resort" Conservative Treatment for Adults With Upper Extremity Burn Contractures?

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Passive range of motion changes

研究概览

简要总结

The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in adults and a lack of studies using strong methodological approaches. There are also no studies investigating the effect of casting on hypertrophic scars (HSc) and on self-reported UE function. This study is a longitudinal case series design with a criteria for change on the use of serial casting for the treatment of upper extremity burn contractures. The purpose of this study is to estimate the extent to which range of motion (AROM and PROM), scar characteristics and patient-reported upper-extremity function changes following an individually-tailored serial casting treatment program after switching from one week of usual care and to determine if these changes can be maintained 3 weeks after stopping serial casting, for adult burn survivors who developed an upper-extremity joint contracture greater than 15% normal range of motion within 1-year post-burn. This study will be a longitudinal case series design with a criteria for change. A minimum of 12 participants will be recruited from the "Centre d'expertise pour les victimes de brûlures graves de l'ouest du Québec" (CEVBGOQ) and will undergo one week of "usual care". If the PROM of the joint does not improve after one week of usual care, the participant will start the serial casting process, which will be prescribed by the treating OT. PROM/AROM and scar characteristics will be measured using a revised goniometry protocol that incorporates cutaneokinematics (CKM) principles and precise skin measures (DermaScan C, Cutometer®, Mexameter® and Tewameter®) at baseline, every Monday and Friday of the treatment weeks and 3 weeks after treatment cessation. Self-reported UE function and satisfaction related to scarring will be assessed at baseline and 3 weeks after treatment cessation using the QuickDASH and the patient satisfaction assessment scale (PSAS). Analysis on ROM and scar characteristic will be conducted using a graphical representation with a projected "usual care" regression line to count how many outcomes were over the line once the treatment was introduced. This study will contribute to building evidence for the use of serial casting following UE burn contractures in the adult population.

详细描述

Participants will undergo a tailored intervention based on their needs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation.
  • •Fire, flame or scald burn injury
  • •≥16 years old
  • •have provided informed consent.

排除标准

  • •Frostbite, chemical or electrical burn injury
  • •A premorbid musculoskeletal or neurological disorder that limited their ROM
  • •Have sustained a neurological injury secondary to the burn injury
  • •A psychiatric or cognitive disorder that limits their ability to follow the research protocol
  • •Have been diagnosed with heterotopic ossification
  • •PROM is contraindicated for any reason
  • •Do not understand English or French.

研究组 & 干预措施

Serial casted joint

Experimental

Tailored serial casting intervention following 1 week of usual care

干预措施: Tailored serial casting intercention (Other)

结局指标

主要结局

Passive range of motion changes

时间窗: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

PROM measures by goniometer (standard and revised goniometry protocol)

Active range of motion changes

时间窗: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention

AROM measures by goniometer (standard and revised goniometry protocol)

次要结局

  • Skin Elasticity Changes(Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention)
  • Patient reported upper-extremity function changes(Baseline, 3 weeks post intervention)
  • Scar patient satisfaction(Baseline, 3 weeks post intervention)
  • Skin Thickness Changes(Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention)
  • Trans-epidermal water loss (TEWL)(Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention)
  • Skin Erythema Changes(Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention)
  • Skin Melanin Changes(Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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