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

NCT ID: NCT05793047

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-16

Study Completion Date

2023-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Hemiplegic Gait Fatigue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FondationbHopale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal RIGAUX

Role: PRINCIPAL_INVESTIGATOR

Hopale Foundation - Jacques Calvé Institute

Locations

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Institut Calvé

Berck, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marine DESEUR

Role: CONTACT

0362882780

Facility Contacts

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Marine Deseur

Role: primary

03 62 88 27 80

Other Identifiers

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HOP22-RIPH3-04

Identifier Type: -

Identifier Source: org_study_id

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