Use of Inertial Sensors to Characterize the Fatigability of Post-stroke Hemiplegic Patients (CIMPA)

FondationbHopale

Status: Enrolling

Conditions: Hemiplegic Gait; Fatigue

Study type: Observational

Funder types: Other

Identifiers

NCT05793047

HOP22-RIPH3-04

Details and patient eligibility

About

This is an experimental, observational, prospective study designed to develop medical knowledge.

The main objective of the study was to identify clinically significant, easily interpretable, quantitative indices of fatigue-related gait pattern changes in post-stroke hemiplegic patients.

This study is part of a usual framework of management of post-stroke hemiplegic patients with additional data collection, via the use of inertial measurement units, considered here as non-interventional.

To achieve this identification, 2 6-minute walk tests will be performed for each patient at the beginning and end of the same day. Patient-perceived fatigue will be recorded by the Borg scale every minute during the 6-minute test. The level of activity during the rehabilitation day is also part of the data collected (number of hours of physical and non-physical activity). At the end of the second 6-minute test, the patient's participation in the study ends.

In addition to the inertial measurement, two scores will be collected to assess the correlation between fatigability and the level of anxiety/depression and stroke severity :

• National Institutes of Health Stroke Scale (NIHSS)
• Hospital Anxiety and Depression Scale (HAD)

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient affiliated or entitled to a social security plan
• Patient who has received informed information about the study and who has given his/her consent
• Post-stroke patients (subacute or chronic)
• 1 single unilateral ischemic or hemorrhagic stroke (supratentorial or subtentorial) confirmed by CT or IRM with consecutive hemiparesis
• No lower extremity surgery
• Ability to walk for 6 minutes without human assistance
• Ability to understand instructions in French

Non inclusion Criteria:

• Patients with cognitive problems that prevent them from understanding instructions
• Patent under guardianship or curatorship
• Post-stroke hemiplegic patient (acute = < 6 months)
• Cardiorespiratory pathology incompatible with CT6
• Chronic decompensated pathology
• Neurological pathology
• Orthopedic pathology of the lower limbs or rheumatic conditions that may affect the ability to walk