Clinical trial NCT05772663: A Rehabilitation Program Based on Daily Activities in Patients With Cerebrovascular Accident
Official title: Elaboration and Evaluation of a Program of Self-rehabilitation Based on Daily Living Activities in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
self-rehabilitation program
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-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

Primary outcomes:
measure: Assessment of Motor and Process Skills AMPS°
timeFrame: Day -7
measure: Assessment of Motor and Process Skills AMPS°
timeFrame: Day 0
measure: Assessment of Motor and Process Skills AMPS°
timeFrame: Day 56
measure: Assessment of Motor and Process Skills AMPS°
timeFrame: Day112
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Day -7
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Day 0
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Day 56
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Day 112
measure: Satisfaction. Visual Analogic Scale (Satisfaction VAS)
timeFrame: D56
measure: program acceptance score
timeFrame: Day 56
measure: program acceptance score
timeFrame: Day 112
measure: Quantity of acceleration (accelerometer wristbands)
timeFrame: Day-7
measure: Quantity of acceleration (accelerometer wristbands)
timeFrame: Day 56
measure: Quantity of acceleration (accelerometer wristbands)
timeFrame: Day 112
measure: Time spent doing the program
timeFrame: at the end of the study, un average of 56 days
Other outcomes:
Locations:
city: Garches
country: France
facility: New Technilogy Platform department, Raymond Poincaré hospital - APHP
Study officials:
affiliation: New technology Platform department, Raymond Poincaré hospital -APHP
name: Samuel POUPLIN, PhD
role: PRINCIPAL_INVESTIGATOR
References: