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NCT Number: NCT06061770

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite

Marseille, Bouches du Rhône, 13009, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted Physical Activity program

Other

Rehabilitation

Adapted physical activity self-program

Other

Rehabilitation

Primary outcomes

  1. Daily activity measurement

    Time frame: through study completion

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

Secondary outcomes

  1. the rate physical activities in Written report

    Time frame: through study completion

    carried out by the patient, more or less helped by his close entourage, recorded in a notebook given at the beginning of the study

  2. 6-minute walk test (6MWT)

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

    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.

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

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

    with a blood pressure cuff

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

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

    with a blood pressure cuff

  5. Borg Rating Scale of Exertion

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

    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

  6. Stroke Specific Quality of Life scale (SS-QoL)

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

    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

  7. Berg Balance Scale (BBS)

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

    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

  8. Activity-specific Balanced Confidence scale (ABC scale)

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

    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

  9. Behavioral regulation in exercise questionnaire

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

    scale used in the literature to assess motivation to perform physical activity ; minimal value : 1 = not true at all ; maximal value : 7 = absolutely true

Study contacts

Contact information is provided by the study sponsor or research team.

Claire MORANDO

CONTACT

[email protected]

04 91 38 21 83

Maeva COTINAT

CONTACT

[email protected]

04 91 74 42 00

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: StrokAPA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 29, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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