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临床试验/NCT05653089
NCT05653089招募中不适用

Evaluation of Actions to Improve Positioning in Wheelchaire Bound Patients at Risk of Slipping : Pilot Study

FondationbHopale2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Evolution of shear measurement with the Shear® sensor

研究概览

简要总结

The choice of the most suitable chair as well as the improvement of the patient's positioning on this wheelchair is important to limit the discomfort, to prevent the risks of bedsores, the pains related to prolonged sitting and finally to support the interaction of the patient with its environment. The goal of this prospective, longitudinale, monocentric study is to evaluate the impact of standardized positioning in wheelchair-bound patients at risk of slipping.

The main questions on the positioning actions are:

  • their actions impact of positioning actions on shear forces
  • their impact on sliding in the chair
  • their impact on the feeling of discomfort in the chair
  • their impact on the caregivers' feelings about the patient's difficulties (eating, transfers, sliding)

Participation in this study will involve an increase in the number of transfers required for shear sheet placement and removal, as well as the time required for ischial measurement and the time to complete the (Tool for Assessing Wheelchair disComfort) TAWC questionnaire.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient hospitalized for a minimum of 9 days (minimum 48-hour reflection period after information)
  • Patient aged between 18 and 80 years,
  • Patient with a sitting time in a wheelchair > or equal to 1 hour,
  • Patient with a neurological condition : multiple sclerosis, stroke, spinal cord injury, Parkinson disease, neurodegenerative diseases...
  • Patient informed of the study and having given his written consent,
  • Non inclusion Criteria:
  • Cognitive disorders that do not allow the understanding of instructions
  • Patient with a pressure sore
  • Pregnant or breastfeeding woman
  • Patient under legal protection

排除标准

  • 未提供

结局指标

主要结局

Evolution of shear measurement with the Shear® sensor

时间窗: Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7

Shear will be measured over a period of one hour (shear evolution over one hour), during which the patient will follow a standardized activity program.

次要结局

  • Comparison of the sliding distance(Day 0 therefore before the implementation of the positioning actions then at Day 1 and Day 7)
  • Evolution of the score on the TAWC scale(Day 0 therefore before the implementation of the positioning actions then at Day 7)
  • Evolution of the caregiver questionnaire score (Likert scale)(Day 0 therefore before the implementation of the positioning actions then at Day 7)

研究者

发起方
FondationbHopale
申办方类型
Other
责任方
Sponsor

研究点 (2)

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