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

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized program of rehabilitation
Routine program of rehabilitation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, self-rehabilitation program

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Technilogy Platform department, Raymond Poincaré hospital - APHP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

personalized program group

routine rehabilitation care group

Arm Description

people with chronic stroke

people with chronic stroke

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Satisfaction. Visual Analogic Scale (Satisfaction VAS)
To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)
program acceptance score
Acceptance questionnaire
program acceptance score
Acceptance questionnaire
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).
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).
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).
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)

Full Information

First Posted
February 10, 2023
Last Updated
August 25, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05772663
Brief Title
A Rehabilitation Program Based on Daily Activities in Patients With Cerebrovascular Accident
Acronym
LARAQS
Official Title
Elaboration and Evaluation of a Program of Self-rehabilitation Based on Daily Living Activities in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, self-rehabilitation program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
personalized program group
Arm Type
Experimental
Arm Description
people with chronic stroke
Arm Title
routine rehabilitation care group
Arm Type
Active Comparator
Arm Description
people with chronic stroke
Intervention Type
Other
Intervention Name(s)
Personalized program of rehabilitation
Intervention Description
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
Intervention Name(s)
Routine program of rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Assessment of Motor and Process Skills AMPS°
Description
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.
Time Frame
Day -7
Title
Assessment of Motor and Process Skills AMPS°
Description
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.
Time Frame
Day 0
Title
Assessment of Motor and Process Skills AMPS°
Description
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.
Time Frame
Day 56
Title
Assessment of Motor and Process Skills AMPS°
Description
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.
Time Frame
Day112
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Day -7
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Day 0
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Day 56
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Day 112
Title
Satisfaction. Visual Analogic Scale (Satisfaction VAS)
Description
To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)
Time Frame
D56
Title
program acceptance score
Description
Acceptance questionnaire
Time Frame
Day 56
Title
program acceptance score
Description
Acceptance questionnaire
Time Frame
Day 112
Title
Quantity of acceleration (accelerometer wristbands)
Description
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).
Time Frame
Day-7
Title
Quantity of acceleration (accelerometer wristbands)
Description
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).
Time Frame
Day 56
Title
Quantity of acceleration (accelerometer wristbands)
Description
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).
Time Frame
Day 112
Title
Time spent doing the program
Description
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)
Time Frame
at the end of the study, un average of 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel POUPLIN, PhD
Phone
+ 33 01.47.10.70.61
Email
samuel.pouplin@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel POUPLIN, PhD
Organizational Affiliation
New technology Platform department, Raymond Poincaré hospital -APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Technilogy Platform department, Raymond Poincaré hospital - APHP
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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