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NCT Number: NCT05772663

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Technilogy Platform department, Raymond Poincaré hospital - APHP

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized program of rehabilitation

Other

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.

Routine program of rehabilitation

Other

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.

Primary outcomes

  1. Assessment of Motor and Process Skills AMPS°

    Time frame: 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.

  2. Assessment of Motor and Process Skills AMPS°

    Time frame: 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.

  3. Assessment of Motor and Process Skills AMPS°

    Time frame: 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.

  4. Assessment of Motor and Process Skills AMPS°

    Time frame: 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 outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: Day -7

    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.

  2. Canadian Occupational Performance Measure (COPM)

    Time frame: Day 0

    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.

  3. Canadian Occupational Performance Measure (COPM)

    Time frame: Day 56

    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.

  4. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

  5. Satisfaction. Visual Analogic Scale (Satisfaction VAS)

    Time frame: D56

    To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)

  6. program acceptance score

    Time frame: Day 56

    Acceptance questionnaire

  7. program acceptance score

    Time frame: Day 112

    Acceptance questionnaire

  8. Quantity of acceleration (accelerometer wristbands)

    Time frame: Day-7

    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).

  9. Quantity of acceleration (accelerometer wristbands)

    Time frame: Day 56

    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).

  10. Quantity of acceleration (accelerometer wristbands)

    Time frame: 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).

  11. Time spent doing the program

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel POUPLIN, PhD

CONTACT

[email protected]

+ 33 01.47.10.70.61

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: LARAQS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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