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

Assistance Publique Hopitaux De Marseille40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Outcomes

Primary Outcomes

Daily activity measurement

Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device

Time frame: through study completion

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

Time frame: 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.