A Rehabilitation Program Based on Daily Activities in Patients With Cerebrovascular Accident
- Conditions
- Stroke
- Interventions
- Other: Personalized program of rehabilitationOther: Routine program of rehabilitation
- Registration Number
- NCT05772663
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 158
- 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
-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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description personalized program group Personalized program of rehabilitation people with chronic stroke routine rehabilitation care group Routine program of rehabilitation people with chronic stroke
- Primary Outcome Measures
Name Time Method Assessment of Motor and Process Skills AMPS° 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.
- Secondary Outcome Measures
Name Time Method Satisfaction. Visual Analogic Scale (Satisfaction VAS) D56 To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)
program acceptance score Day 112 Acceptance questionnaire
Time spent doing the program at the end of the study, un average of 56 days To assess adherence to the self-rehabilitation program, investigators will use a monitoring notebook completed by the person with stroke on the follow-up of sessions / self-rehabilitation time.
Outcome measure in time (hours per week)Canadian Occupational Performance Measure (COPM) Day 112 The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Quantity of acceleration (accelerometer wristbands) Day 112 Quantity of acceleration per upper limb (number of acceleration) It will be established on the basis of an accelerometer wearing time of 168 hours (7 days continuously).
Trial Locations
- Locations (1)
New Technilogy Platform department, Raymond Poincaré hospital - APHP
🇫🇷Garches, France