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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05772663
Acronym
LARAQS
Enrollment
158
Registered
2023-03-16
Start date
2025-11-30
Completion date
2028-09-30
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, self-rehabilitation program

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.

Interventions

OTHERPersonalized 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.

OTHERRoutine 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Motor and Process Skills AMPS°Day -7The 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

MeasureTime frameDescription
Canadian Occupational Performance Measure (COPM)Day -7The 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.
Satisfaction. Visual Analogic Scale (Satisfaction VAS)D56To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)
program acceptance scoreDay 56Acceptance questionnaire
Quantity of acceleration (accelerometer wristbands)Day-7Quantity 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).
Time spent doing the programat the end of the study, un average of 56 daysTo 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)

Countries

France

Contacts

Primary ContactSamuel POUPLIN, PhD
samuel.pouplin@aphp.fr+ 33 01.47.10.70.61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026