An observational study in Hemiplegic Gait and Fatigue, sponsored by FondationbHopale. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by FondationbHopale · Observational
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 :
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's planned enrollment of 30 is below the median of 54 across 75 observational studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →FondationbHopale is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Non inclusion Criteria:
Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and walk ratio (stride length / cadence (cm/(steps/min)))
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and step length (cm)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and speed (meter per second)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and cycles phases: single and double support (second)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and postural control: step width (cm) and standard deviation (cm)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and asymmetry dtermined by stride length ratio and single stance duration ratio
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and walk ratio (stride length / cadence (cm/(steps/min)))
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and step length (cm)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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
Relationships between fatigue measured by the Borg scale during 6-minute test and speed (meter per second)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and cycles phases: single and double support (second)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and postural control: step width (cm) and standard deviation (cm)
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Relationships between fatigue measured by the Borg scale during 6-minute test and asymmetry determined by stride length ratio and single stance duration ratio
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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.
Change cadence (number of steps per minute) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
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
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
Change step length (cm) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
Change speed (meter per second) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
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
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
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
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
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
The 6-min walk test (TM6) measures the greatest distance covered in 6 min of walking around two studs separated by 30 meters. The Borg Scale is a quantitative measure of perceived exertion during exercise. The Borg scale is rated from 6 to 20. The highest value represents a maximum perception of effort. The Borg scale will be assessed every minute of the 6-minute test. Recording of gait characteristics takes place during the entire 6-minute test.
Time frame: 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).
To assess the correlation between fatigability and the level of anxiety/depression
Questionnaire Hospital Anxiety and Depression scale (HAD) The Hospital Anxiety and Depression scale (HAD) questionnaire is used to screen for anxiety and depressive disorders. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score: 21). A score close to 0 means no anxiety symptoms a score close to 11 and above indicates anxiety symptoms. This scale is validated in French.
Time frame: During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
To assess the correlation between fatigability and stroke severity
National Institutes of Health Stroke Scale (NIHSS) The National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment rating scale designed to assess the neurological consequences and degree of recovery of a stroke patient. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe brain damage.
Time frame: During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
Plan to share: No
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