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

Stroke Clinical Trial

— LARAQS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05772663
• Other study ID #: 22SPN-LARAQS
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Samuel POUPLIN, PhD
• Phone: + 33 01.47.10.70.61
• Email: samuel.pouplin[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	New Technilogy Platform department, Raymond Poincaré hospital - APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satisfaction. Visual Analogic Scale (Satisfaction VAS)	To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)	D56
Secondary	program acceptance score	Acceptance questionnaire	Day 56
Secondary	program acceptance score	Acceptance questionnaire	Day 112
Secondary	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
Secondary	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
Secondary	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
Secondary	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