A Rehabilitation Program Based on Daily Activities in Patients With Cerebrovascular Accident

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Personalized program of rehabilitation
  D56: Follow-up visit (D56). Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis. Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands. D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelet
• Другое Routine program of rehabilitation
  Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis. Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands. D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 p

Первичные конечные точки

• Assessment of Motor and Process Skills AMPS° [Срок оценки: Day -7]
• Assessment of Motor and Process Skills AMPS° [Срок оценки: Day 0]
• Assessment of Motor and Process Skills AMPS° [Срок оценки: Day 56]
• Assessment of Motor and Process Skills AMPS° [Срок оценки: Day112]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

-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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• New Technilogy Platform department, Raymond Poincaré hospital - APHP — Garches

Идентификаторы

NCT: NCT05772663 · APHP220833 · 2023-A00302-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗