Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke

Study Overview
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Brief Summary
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This is a prospective, randomized, controlled, two parallel arms, single-blind pilot study. In this design, all included patients in the chronic phase of a stroke will receive both modes of physical activity. This study includes patients over 18 years of age with spastic hemiparesis sequelae of a first unilateral hemispheric stroke older than 6 months and able to walk for 6 minutes. The non-inclusion criteria were the inability to walk without human assistance (with or without technical aids), the existence of cognitive disorders compromising informed consent, in particular the inability to understand the objective and the modalities of the protocol, the inability to communicate with the examiners, and the presence of an additional neurological disorder or a pathology contraindicating the practice of physical activity. The primary endpoint is based on daily activity measurement by measuring the number of steps per day, collected over the duration of the study, via a Stepwatch™ device. Secondary end points involve a written physical activity report, assessment of walking ability (via walking-test 6, heart rate, and blood pressure), a measure of perceived exertion, stroke-specific quality of life, balance, and motivation to perform physical activity.

Official Title
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Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Adapted physical activity program
* Other: Adapted physical activity self-program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Left or right spastic hemiparesis after a first hemorrhagic or ischemic unilateral stroke older than 6 months Walking possible for 6 minutes Exclusion Criteria: Inability to walk without human assistance (with or without technical aids) Cognitive impairment that compromises informed consent, including inability to understand the purpose and terms of the protocol Inability to communicate Presence of an additional neurological disorder Medical conditions that contraindicate physical activity, such as an unbalanced cardiovascular or respiratory condition Concurrent participation in another clinical research project

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First APA program<br>The evaluation of the primary endpoint to meet our main objective will be done at W13 for both groups. The addition of an APA program in autonomy following the structured program for group 1 will make it possible to answer a secondary question focusing on the comparison of the effectiveness of the self-directed program carried out alone or following a structured program. 1st group: D0: Include S1-S12: APA program at IUR Valmante S13: Break S14-S25: APA Autoprogram In addition, the patients in group 1 are maintained in the follow-up to study the maintenance of any observed effect. | Other: Adapted physical activity program<br>* Rehabilitation<br>|
| Active Comparator: Second APA program<br>Our study design provides for compensatory participation in the structured program for patients in group 2, following the self-program. From an ethical point of view, this scheme allows all patients included in the structured APA program to benefit. 2nd group: D0: Include S1-S12: APA Autoprogram S13: End of study S14-S25: APA program at IUR Valmante compensatory | Other: Adapted physical activity self-program<br>* Rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily activity measurement | Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device | through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate physical activities in Written report | carried out by the patient, more or less helped by his close entourage, recorded in a notebook given at the beginning of the study | through study completion | 
| 6-minute walk test (6MWT) | A test validated in the literature that consists of measuring the greatest distance that a subject can travel on a flat surface (30 meter corridor) in 6 minutes. | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Measurement of heart rate at rest and after 6-minute walk test | with a blood pressure cuff | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Measurement of systolic blood pressure at rest and after 6-minute walk test | with a blood pressure cuff | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Borg Rating Scale of Exertion | test validated in the literature that allows the evaluation of the perception of effort by the patient ; minimum value : 0 = rest : no exertion ; maximum value : 10 = maximal exertion | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Stroke Specific Quality of Life scale (SS-QoL) | A test validated in French in the literature that assesses the specific quality of life of stroke patients in 49 items ; minimum value : 1 = Total help/ Couldn't do it at all/ Strongly agree ; maximum value : 5 = No help needed/ No trouble at all/ Strongly disagree | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Berg Balance Scale (BBS) | validated scale allowing, by means of 14 instructions, an evaluation of balance, reproducible and sensitive to change ; minimum score : 0-20 = high risk of falling ; maximal score : 56 = no risk of falling | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Activity-specific Balanced Confidence scale (ABC scale) | French language validated scale assessing the patient's confidence in his or her balance, using 16 situations where the subject is asked to rate his or her balance on a numerical scale ; minimal rate : 0% = not at all confident ; maximal rate : 100% = completely confident | at inclusion Day and at the 13th week (and the 26th week for one group only) | 
| Behavioral regulation in exercise questionnaire | scale used in the literature to assess motivation to perform physical activity ; minimal value : 1 = not true at all ; maximal value : 7 = absolutely true | at inclusion Day and at the 13th week (and the 26th week for one group only) |