Hemiplegic GaitCIMPANCT05793047
Use of Inertial Sensors to Characterize the Fatigability of Post-stroke Hemiplegic Patients
An observational study of Hemiplegic Gait and Fatigue, run by FondationbHopale at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegic Gait, Fatigue
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Calvé
Berck
Marine Deseur, 03 62 88 27 80
About this study
Official title: Characterization of Fatigue From Data From Inertial Units: Gait Analysis in Hemiplegic Post-stroke Patients
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.
Read more
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)
- Conditions
- Hemiplegic Gait, Fatigue
- Medical subject headings
- Gait Disorders, Neurologic, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (2)
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.
Measured: 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.
Measured: During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start16 Jan 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FondationbHopale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal RIGAUX, Principal investigator, Hopale Foundation - Jacques Calvé Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793047
- Sponsor's protocol ID
- HOP22-RIPH3-04
- Acronym
- CIMPA
- Status last verified
- Mar 2023
- First submitted
- 5 Jan 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Fatigue From Data From Inertial Units: Gait Analysis in Hemiplegic Post-stroke Patients
- ClinicalTrials.gov ID
- NCT05793047
- Acronym / sponsor ID
- CIMPA / HOP22-RIPH3-04
- Conditions
- Hemiplegic Gait, Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- FondationbHopaleUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and walk ratio (stride length / cadence (cm/(steps/min)))
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and step length (cm)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and speed (meter per second)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and cycles phases: single and double support (second)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and postural control: step width (cm) and standard deviation (cm)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and asymmetry dtermined by stride length ratio and single stance duration ratio
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and walk ratio (stride length / cadence (cm/(steps/min)))
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and step length (cm)
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
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and speed (meter per second)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and cycles phases: single and double support (second)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and postural control: step width (cm) and standard deviation (cm)
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.
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.
Relationships between fatigue measured by the Borg scale during 6-minute test and asymmetry determined by stride length ratio and single stance duration ratio
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.
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 cadence (number of steps per minute) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
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).
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 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
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).
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 step length (cm) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
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).
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 speed (meter per second) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
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).
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 cycle phase: single and double support (second) in fonction of the fatigue measured by the Borg scale recorded during the two 6-minute tests
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).
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 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
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).
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 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
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).
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.
2 secondary outcomes
To assess the correlation between fatigability and the level of anxiety/depression
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
Time frame: During the one day of patient assessment. Assessed only once for each patient before performing the first 6-minute test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal RIGAUX principal investigator
Hopale Foundation - Jacques Calvé Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegic Gait and Fatigue, run by FondationbHopale at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine DESEUR (0362882780, marine.deseur@fondation-hopale.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationships between fatigue measured by the Borg scale during 6-minute test and cadence (number of steps per minute) (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.). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.