Cerebral PalsyKAPP-IMU ancNCT06138925
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy
A study testing Analysis of walking and Analysis of running in people with Cerebral Palsy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Analysis of walking and Analysis of running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who have given their consent and whose legal representatives have given their consent
- Age between 7 and 17 years,
- Children able to understand simple commands and instructions.
- Children living within a maximum radius of 50 km of the investigation site.
- Child covered by national health insurance.
- PATIENT GROUP (IN ADDITION TO THOSE ABOVE)
- Children with proven cerebral palsy resulting in locomotor impairment but able to move around without technical aids (cane, wheelchair).
- Child covered by national health insurance.
Who cannot join
- Children with a condition other than cerebral palsy that affects their ability to walk.
- Child subject to a measure of legal protection
- A child unable to give consent
- Pregnant, parturient or breast-feeding participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Mathieu GUEUGNON, 03 80 29 38 72 ext. +33, mathieu.gueugnon@chu-dijon.fr
About this study
Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life.
Today, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.
- Conditions
- Cerebral Palsy
- Being tested
- Analysis of walking, Analysis of running
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of walkingOther
3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at different speeds (slow, comfortable and fast)
Analysis of runningOther
analysis of running on flat ground at different speeds (comfortable and fast)
Analysis of walkingOther
3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at spontaneous speed (comfortable).
| Study group | Role | What they receive |
|---|---|---|
| healthy children | Active comparator | Not described Receives: Other: Analysis of walking; Other: Analysis of running |
| hildren with cerebral palsy | Experimental | Not described Receives: Other: Analysis of walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
participants' walking speed measured jointly by an IMU system in the shoe and a 3D locomotion analysis system
Measured: During the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start31 Jan 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT06138925
- Sponsor's protocol ID
- ORNETTI 2023
- Acronym
- KAPP-IMU anc
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2023
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. 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 Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06138925
- Acronym / sponsor ID
- KAPP-IMU anc / ORNETTI 2023
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Nov 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.
Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life.
Today, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy children | Active comparator | Other: Analysis of walking, Other: Analysis of running |
| hildren with cerebral palsy | Experimental | Other: Analysis of walking |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children who have given their consent and whose legal representatives have given their consent
- Age between 7 and 17 years,
- Children able to understand simple commands and instructions.
- Children living within a maximum radius of 50 km of the investigation site.
- Child covered by national health insurance.
Key exclusion criteria (4 listed)
- Children with a condition other than cerebral palsy that affects their ability to walk.
- Child subject to a measure of legal protection
- A child unable to give consent
- Pregnant, parturient or breast-feeding participant
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 walking3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at different speeds (slow, comfortable and fast) | Other | healthy children |
| Analysis of runninganalysis of running on flat ground at different speeds (comfortable and fast) | Other | healthy children |
| Analysis of walking3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at spontaneous speed (comfortable). | Other | hildren with cerebral palsy |
Primary outcome
Walking speed
Time frame: During the study visit
participants' walking speed measured jointly by an IMU system in the shoe and a 3D locomotion analysis system
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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.
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 walking and Analysis of running in people with Cerebral Palsy, 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 4 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul ORNETTI (03 80 29 38 72 ext. +33, 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: During the study visit). 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 27 Mar 2026.