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Not yet recruiting NCT05772663

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized program of rehabilitation, Routine program of rehabilitation.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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 bracelet
  • 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 p

Primary outcome measures

  • Assessment of Motor and Process Skills AMPS° [Time frame: Day -7]
  • Assessment of Motor and Process Skills AMPS° [Time frame: Day 0]
  • Assessment of Motor and Process Skills AMPS° [Time frame: Day 56]
  • Assessment of Motor and Process Skills AMPS° [Time frame: Day112]
Secondary outcome measures (11)
  • Canadian Occupational Performance Measure (COPM) [Time frame: Day -7]
  • Canadian Occupational Performance Measure (COPM) [Time frame: Day 0]
  • Canadian Occupational Performance Measure (COPM) [Time frame: Day 56]
  • Canadian Occupational Performance Measure (COPM) [Time frame: Day 112]
  • Satisfaction. Visual Analogic Scale (Satisfaction VAS) [Time frame: D56]
  • program acceptance score [Time frame: Day 56]
  • program acceptance score [Time frame: Day 112]
  • Quantity of acceleration (accelerometer wristbands) [Time frame: Day-7]
  • Quantity of acceleration (accelerometer wristbands) [Time frame: Day 56]
  • Quantity of acceleration (accelerometer wristbands) [Time frame: Day 112]
  • Time spent doing the program [Time frame: at the end of the study, un average of 56 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • New Technilogy Platform department, Raymond Poincaré hospital - APHP — Garches

Identifiers

NCT: NCT05772663 · APHP220833 · 2023-A00302-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗