跳至主要内容
临床试验/NCT05772663
NCT05772663尚未招募不适用

Elaboration and Evaluation of a Program of Self-rehabilitation Based on Daily Living Activities in Patients With Chronic Stroke

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
158
试验地点
1
主要终点
Assessment of Motor and Process Skills AMPS°

研究概览

简要总结

Mixed qualitative and quantitative study, in two phases:

Creation of a self-rehabilitation program based on people's daily living activities and designed with and for them.

Randomized controlled study to explore whether there is a potential benefit for patients with chronic stroke to use a self-rehabilitation program.

详细描述

In France, stroke affects nearly 150,000 people per year and is therefore a major problem public health in France but also in Europe . With improved support treatment, the mortality rate decreases, but the sequelae, linked to the consequences of the stroke, remain numerous . More than 88% of stroke victims return at home upon discharge from hospital rehabilitation. However more and more people experience difficulties as a result of this return. Hospital discharge entails an imbalance between the period of hospitalization and place of residence in terms of the frequency and intensity of rehabilitation. In fact, the person benefits from rehabilitation during his hospitalization daily. After returning home, the person no longer benefits only 1 to 2 rehabilitation sessions per week, sometimes less . In view of these different elements, the investigators issue the assumption that making available to people AVC a self-rehabilitation program designed with and for them and centered on the meaningful occupations of the person will allow an increase in their occupational performance in their life activities daily. The aim of this study is to create a self-rehabilitation program based on people's daily living activities and designed with and for them and to evaluate the benefits of this program with a randomized controlled study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Having had a stroke ischemic or hemorrhagic for more than 6 months before inclusion in the study.
  • •Having had a single cerebral hemispheric lesion
  • •Patient informed and having signed consent

排除标准

  • •Patient under guardianship or curatorship
  • •Pregnant or breastfeeding women
  • •Cognitive impairment defined by BDAE <3
  • •Previous operation of the paretic limb at course of the last 6 months at inclusion
  • •Total absence of motor skills in the upper limb hemiplegic

研究组 & 干预措施

personalized program group

Experimental

people with chronic stroke

干预措施: Personalized program of rehabilitation (Other)

routine rehabilitation care group

Active Comparator

people with chronic stroke

干预措施: Routine program of rehabilitation (Other)

结局指标

主要结局

Assessment of Motor and Process Skills AMPS°

时间窗: Day112

The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

Assessment of Motor and Process Skills AMPS°

时间窗: Day -7

The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

Assessment of Motor and Process Skills AMPS°

时间窗: Day 0

The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

Assessment of Motor and Process Skills AMPS°

时间窗: Day 56

The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

次要结局

  • Satisfaction. Visual Analogic Scale (Satisfaction VAS)(D56)
  • program acceptance score(Day 112)
  • Time spent doing the program(at the end of the study, un average of 56 days)
  • Canadian Occupational Performance Measure (COPM)(Day 112)
  • Quantity of acceleration (accelerometer wristbands)(Day 112)
  • Canadian Occupational Performance Measure (COPM)(Day -7)
  • Canadian Occupational Performance Measure (COPM)(Day 0)
  • Canadian Occupational Performance Measure (COPM)(Day 56)
  • program acceptance score(Day 56)
  • Quantity of acceleration (accelerometer wristbands)(Day-7)
  • Quantity of acceleration (accelerometer wristbands)(Day 56)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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