Cerebral Vascular AccidentKAPP-IMUNCT05104645
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients
A study testing Analysis of the walk, Analysis of the race and Unipodal and bipodal jumps on flat ground in people with Cerebral Vascular Accident, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Vascular Accident
- What is being tested?
- Analysis of the walk, Analysis of the race and Unipodal and bipodal jumps on flat ground
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to Nov 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Person who has given oral consent
- man or woman 18 years or older
- a person who is able to understand simple orders, instructions for locomotion
- person living within a maximum radius of 50 km from the investigation site
- Patients (in addition to the above):
- persons who have had a stroke of any origin in the last 6 months
- person included in a rehabilitation protocol
Who cannot join
- persons who are not affiliated to national health insurance
- persons subject to a legal protection measure (guardianship)
- persons who are subject to a legal protection measure
- pregnant women
- adult unable to express consent
- subject with a disarticulated hip
- Subjects with diseases or disabilities that have an impact on walking other than those related to the stroke.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Mathieu GUEUGNON, 03 80 29 38 72, mathieu.gueugnon@chu-dijon.fr
About this study
Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.
- Conditions
- Cerebral Vascular Accident
- Being tested
- Analysis of the walk, Analysis of the race, Unipodal and bipodal jumps on flat ground
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the walkOther
Gait analysis in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Patients: S0, S1, S2, S4 and S6 Healthy volunteers: 2 times (between 3 and 20 days apart)
Analysis of the raceOther
Analysis of running in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Healthy volunteers: 2 times (between 3 and 20 days apart)
Unipodal and bipodal jumps on flat groundOther
Healthy volunteers: 2 times (between 3 and 20 days apart)
| Study group | Role | What they receive |
|---|---|---|
| Patients after a Stroke | Experimental | Not described Receives: Other: Analysis of the walk |
| Healthy Volunteering | Active comparator | Not described Receives: Other: Analysis of the walk; Other: Analysis of the race; Other: Unipodal and bipodal jumps on flat ground |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Measured: Patients: Change from baseline at week 6
Walking speed
Measured: Healthy volunteers: Change from baseline at 20 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start29 Sep 2021
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Vascular AccidentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104645
- Sponsor's protocol ID
- ORNETTI DIGITSOLE 2021
- Acronym
- KAPP-IMU
- Status last verified
- Aug 2023
- First submitted
- 27 Sep 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients
- ClinicalTrials.gov ID
- NCT05104645
- Acronym / sponsor ID
- KAPP-IMU / ORNETTI DIGITSOLE 2021
- Conditions
- Cerebral Vascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Nov 2021 (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.
Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after a Stroke | Experimental | Other: Analysis of the walk |
| Healthy Volunteering | Active comparator | Other: Analysis of the walk, Other: Analysis of the race, Other: Unipodal and bipodal jumps on flat ground |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers:
- Person who has given oral consent
- man or woman 18 years or older
- a person who is able to understand simple orders, instructions for locomotion
- person living within a maximum radius of 50 km from the investigation site
Key exclusion criteria (7 listed)
- persons who are not affiliated to national health insurance
- persons subject to a legal protection measure (guardianship)
- persons who are subject to a legal protection measure
- pregnant women
- adult unable to express consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of the walkGait analysis in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Patients: S0, S1, S2, S4 and S6 Healthy volunteers: 2 times (between 3 and 20 days apart) | Other | Healthy Volunteering, Patients after a Stroke |
| Analysis of the raceAnalysis of running in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Healthy volunteers: 2 times (between 3 and 20 days apart) | Other | Healthy Volunteering |
| Unipodal and bipodal jumps on flat groundHealthy volunteers: 2 times (between 3 and 20 days apart) | Other | Healthy Volunteering |
Primary outcome
Walking speed
Time frame: Patients: Change from baseline at week 6
Walking speed
Time frame: Healthy volunteers: Change from baseline at 20 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of the walk, Analysis of the race and Unipodal and bipodal jumps on flat ground in people with Cerebral Vascular Accident, run by Centre Hospitalier Universitaire Dijon 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 8 inclusion and 7 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 13 Sep 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 Paul ORNETTI (03 80 29 38 72, paul.ornetti@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Patients: Change from baseline at week 6). The study lists 2 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 13 Sep 2023.