Use of Inertial Sensors to Characterize the Fatigability of Post-stroke Hemiplegic Patients
NCT ID: NCT05793047
Last Updated: 2023-04-05
Study Results
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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UNKNOWN
30 participants
OBSERVATIONAL
2023-01-16
2023-12-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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FondationbHopale
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Marine Deseur
Role: primary
Other Identifiers
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HOP22-RIPH3-04
Identifier Type: -
Identifier Source: org_study_id
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