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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Personalized program of rehabilitation; Other: Routine program of rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel POUPLIN, PhD; Phone Number: + 33 01.47.10.70.61; Email: samuel.pouplin@aphp.fr

Study Locations

• France
  • Garches, France, 92380
    • New Technilogy Platform department, Raymond Poincaré hospital - APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: personalized program group; people with chronic stroke	Other: 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 bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20*20). At D119, the person returns the accelerometric writbands.
Active Comparator: routine rehabilitation care group; people with chronic stroke	Other: 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 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20*20). At D119, the person returns the accelerometric writbands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Motor and Process Skills AMPS°	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.	Day -7
Assessment of Motor and Process Skills AMPS°	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.	Day 0
Assessment of Motor and Process Skills AMPS°	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.	Day 56
Assessment of Motor and Process Skills AMPS°	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.	Day112

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Occupational Performance Measure (COPM)	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.	Day -7
Canadian Occupational Performance Measure (COPM)	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.	Day 0
Canadian Occupational Performance Measure (COPM)	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.	Day 56
Canadian Occupational Performance Measure (COPM)	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.	Day 112
Satisfaction. Visual Analogic Scale (Satisfaction VAS)	To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)	D56
program acceptance score	Acceptance questionnaire	Day 56
program acceptance score	Acceptance questionnaire	Day 112
Quantity of acceleration (accelerometer wristbands)	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).	Day-7
Quantity of acceleration (accelerometer wristbands)	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).	Day 56
Quantity of acceleration (accelerometer wristbands)	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).	Day 112
Time spent doing the program	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)	at the end of the study, un average of 56 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Samuel POUPLIN, PhD, New technology Platform department, Raymond Poincaré hospital -APHP

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; self-rehabilitation program
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: APHP220833; 2023-A00302-43 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No