About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Adapted physical activity program
Other interventionRehabilitation
Adapted physical activity self-program
Other interventionRehabilitation
Treatment groups
Trial outcomes
Primary outcomes
Daily activity measurement
Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device
Secondary outcomes
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
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.
Measurement of heart rate at rest and after 6-minute walk test
with a blood pressure cuff
Measurement of systolic blood pressure at rest and after 6-minute walk test
with a blood pressure cuff
Sponsors and contacts
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