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 (StrokAPA)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Stroke

Treatments: Other: Adapted physical activity program; Other: Adapted physical activity self-program

Study type: Interventional

Funder types: Other

Identifiers

NCT06061770

RCAPHM21_0439

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

First APA program

Experimental group

Description:

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.

Treatment:

Other: Adapted physical activity program

Second APA program

Active Comparator group

Description:

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

Treatment:

Other: Adapted physical activity self-program