Clinical trial NCT05793047: Use of Inertial Sensors to Characterize the Fatigability of Post-stroke Hemiplegic Patients
Official title: Characterization of Fatigue From Data From Inertial Units: Gait Analysis in Hemiplegic Post-stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemiplegic Gait
Fatigue
Lead sponsor: FondationbHopale
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were recruited from among the patients followed for post-stroke rehabilitation at the Jacques Calvé Jacques Calvé rehabilitation center in Berck-sur-Mer.

Brief summary: 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)


Eligibility 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

Primary outcomes:
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute)
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and walk ratio (stride length / cadence (cm/(steps/min)))
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and step length (cm)
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and speed (meter per second)
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and cycles phases: single and double support (second)
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and postural control: step width (cm) and standard deviation (cm)
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and asymmetry dtermined by stride length ratio and single stance duration ratio
timeFrame: The 6-minute test takes place at the beginning of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute)
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and walk ratio (stride length / cadence (cm/(steps/min)))
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and step length (cm)
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and speed (meter per second)
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and cycles phases: single and double support (second)
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and postural control: step width (cm) and standard deviation (cm)
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Relationships between fatigue measured by the Borg scale during 6-minute test and asymmetry determined by stride length ratio and single stance duration ratio
timeFrame: The 6-minute test takes place at the end of the single day of inclusion.Recording of gait characteristics takes place during the entire 6-minute test. The Borg scale will be assessed every minute of the 6-minute test.
measure: Change cadence (number of steps per minute) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
measure: Change walk ratio (stride length / cadence (cm/(steps/min))) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
measure: Change step length (cm) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
measure: Change speed (meter per second) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
measure: Change cycle phase: single and double support (second) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
measure: Change postural control: step width (cm) and standard deviation (cm) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
measure: Change asymmetry: stride length ratio; single stance duration ratio in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
timeFrame: Change of the gait parameter between the beginning of the single day of inclusion (before the rehabilitation) and the end of the single day of inclusion (after the rehabilitation sessions).
Secondary outcomes:
measure: To assess the correlation between fatigability and the level of anxiety/depression
timeFrame: During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
measure: To assess the correlation between fatigability and stroke severity
timeFrame: During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
Other outcomes:
Locations:
city: Berck
country: France
facility: Institut Calvé
Study officials:
affiliation: Hopale Foundation - Jacques Calvé Institute
name: Pascal RIGAUX
role: PRINCIPAL_INVESTIGATOR
References: