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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05793047
Other study ID # HOP22-RIPH3-04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 16, 2023
Est. completion date December 2023

Study information

Verified date March 2023
Source FondationbHopale
Contact Marine DESEUR
Phone 0362882780
Email marine.deseur@fondation-hopale.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Institut Calvé Berck

Sponsors (1)

Lead Sponsor Collaborator
FondationbHopale

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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.
Primary 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.
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).
Primary 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.
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).
Primary 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.
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).
Primary 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.
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).
Primary 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.
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).
Primary 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.
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).
Primary 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.
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 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. During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
Secondary 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.
During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
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