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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Adapted physical activity program

    Other intervention

    Rehabilitation

  • Adapted physical activity self-program

    Other intervention

    Rehabilitation

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: First APA programExperimental treatment 1 intervention
Group B: Second APA programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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.

Time frame
at inclusion Day and at the 13th week (and the 26th week for one group only)
3

Measurement of heart rate at rest and after 6-minute walk test

with a blood pressure cuff

Time frame
at inclusion Day and at the 13th week (and the 26th week for one group only)
4

Measurement of systolic blood pressure at rest and after 6-minute walk test

with a blood pressure cuff

Time frame
at inclusion Day and at the 13th week (and the 26th week for one group only)

Other outcomes

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