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

NCT ID: NCT05772663

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

personalized program group

people with chronic stroke

Group Type: EXPERIMENTAL

Personalized program of rehabilitation

Intervention Type: 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 rehabilitation care group

people with chronic stroke

Group Type: ACTIVE_COMPARATOR

Routine program of rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel POUPLIN, PhD

Role: PRINCIPAL_INVESTIGATOR

New technology Platform department, Raymond Poincaré hospital -APHP

Locations

New Technilogy Platform department, Raymond Poincaré hospital - APHP

Garches, , France

Countries

France

Central Contacts

Samuel POUPLIN, PhD

Role: CONTACT

samuel.pouplin@aphp.fr

+ 33 01.47.10.70.61

Other Identifiers

2023-A00302-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP220833

Identifier Type: -

Identifier Source: org_study_id