Healthy VolunteersKER-EGI-KidsNCT07212257
Creation of a Pediatric Reference Database for the Kerpape-Rennes-EMG-Based Gait Index
A study testing Gait analysis with surface electromyography (EMG) in people with Healthy Volunteers and Normal Gait, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape at 1 site in France.
Trial summary
Brief Summary This prospective, monocentric national study aims to establish normative reference data for the Ker-EGI (Kerpape Gait Index), a novel gait quantification index based on muscle activation profiles of the lower limbs in children. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Normal Gait, Child Development
- What is being tested?
- Gait analysis with surface electromyography (EMG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2024to 29 Aug 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child/adolescent aged 3 to 15 years who has given assent, and whose parents (or legal representative) have provided consent to participate in this study.
- Affiliation with a social security system or beneficiary of such a system.
Who cannot join
- Any known pathology affecting gait pattern (lower limbs, upper limbs, or spine).
- History of orthopedic surgery.
- Behavioral disorder incompatible with data collection.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
Ploemeur, 56270
About this study
Brief Summary
This prospective, monocentric national study aims to establish normative reference data for the Ker-EGI (Kerpape Gait Index), a novel gait quantification index based on muscle activation profiles of the lower limbs in children. The objective is to determine both the mean activation profile and its variability in a healthy pediatric population.
Read more
Participants are healthy children and adolescents, aged 3 to 15 years, recruited outside of the Kerpape Rehabilitation Center and specifically attending the Kerpape gait laboratory for this study. A total of 120 subjects are expected. Each participant and their parent(s)/legal guardian provide informed consent prior to enrollment.
Study Procedure:
Each child is accompanied by at least one parent and participates in a single session lasting approximately one hour. After skin preparation (shaving if necessary and cleaning with alcohol), 28 surface electrodes (ECG type) are placed bilaterally on seven lower limb muscles (tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis, semitendinosus, and gluteus medius). Anatomical landmarks are marked with a dermographic pencil. For younger children, a doll is used to facilitate explanation of electrode placement.
The gait analysis is performed with the child in underwear from the time of electrode placement. Each participant completes 10 walking trials (five round trips of 10 meters) at self-selected comfortable speed, following demonstration or a test trial if necessary. Gait is recorded using synchronized cameras and video recordings are anonymized daily.
Data Collection:
Collected data include participant demographics (name, age, sex, height, weight, leg length), electrode signals, and video recordings. Following the session, electrodes are removed, and children are invited to get dressed.
Constraints and Risks:
The study involves a minimal deviation from routine conditions: a single one-hour session including electrode placement, walking assessment, and filming. No invasive procedures or therapeutic interventions are conducted.
Sample Size:
120 healthy children and adolescents, aged 3 to 15 years.
- Conditions
- Healthy Volunteers, Normal Gait, Child Development, Gait, Normal Gait in Children, Pediatric Normative Gait Data
- Being tested
- Gait analysis with surface electromyography (EMG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis with surface electromyography (EMG)Procedure or surgery
Each participant undergoes a standardized gait analysis session. After skin preparation, 28 surface electrodes are placed bilaterally on seven lower limb muscles. The child completes 10 walking trials (five round trips of 10 meters) at a comfortable, self-selected speed while being recorded by synchronized cameras. Data collected include Electromyography signals and video recordings. This procedure is non-invasive and performed in a single session lasting approximately one hour
| Study group | Role | What they receive |
|---|---|---|
| Healthy children and adolescents (3-15 years) undergoing gait analysis | Experimental | Not described Receives: Procedure: Gait analysis with surface electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normative Kerpape Gait Index-Kids (Ker-EGI Kids) in children
Establishment of a reference database for the Ker-EGI Kids, a gait quantification index based on lower limb muscle activation profiles in children aged 3 to 15 years. The primary outcome is the mean Ker-EGI Kids profile and its variability, with a maximum margin of error of 10%.
Measured: Single session per participant (~1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start17 Apr 2024
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212257
- Sponsor's protocol ID
- 2024-A00178-39
- Acronym
- KER-EGI-Kids
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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
- Creation of a Pediatric Reference Database for the Kerpape-Rennes-EMG-Based Gait Index
- ClinicalTrials.gov ID
- NCT07212257
- Acronym / sponsor ID
- KER-EGI-Kids / 2024-A00178-39
- Conditions
- Healthy Volunteers, Normal Gait, Child Development, Gait, Normal Gait in Children, Pediatric Normative Gait Data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KerpapeUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 8 Oct 2025 (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.
Brief Summary
This prospective, monocentric national study aims to establish normative reference data for the Ker-EGI (Kerpape Gait Index), a novel gait quantification index based on muscle activation profiles of the lower limbs in children. The objective is to determine both the mean activation profile and its variability in a healthy pediatric population.
Participants are healthy children and adolescents, aged 3 to 15 years, recruited outside of the Kerpape Rehabilitation Center and specifically attending the Kerpape gait laboratory for this study. A total of 120 subjects are expected. Each participant and their parent(s)/legal guardian provide informed consent prior to enrollment.
Study Procedure:
Each child is accompanied by at least one parent and participates in a single session lasting approximately one hour. After skin preparation (shaving if necessary and cleaning with alcohol), 28 surface electrodes (ECG type) are placed bilaterally on seven lower limb muscles (tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis, semitendinosus, and gluteus medius). Anatomical landmarks are marked with a dermographic pencil. For younger children, a doll is used to facilitate explanation of electrode placement.
The gait analysis is performed with the child in underwear from the time of electrode placement. Each participant completes 10 walking trials (five round trips of 10 meters) at self-selected comfortable speed, following demonstration or a test trial if necessary. Gait is recorded using synchronized cameras and video recordings are anonymized daily.
Data Collection:
Collected data include participant demographics (name, age, sex, height, weight, leg length), electrode signals, and video recordings. Following the session, electrodes are removed, and children are invited to get dressed.
Constraints and Risks:
The study involves a minimal deviation from routine conditions: a single one-hour session including electrode placement, walking assessment, and filming. No invasive procedures or therapeutic interventions are conducted.
Sample Size:
120 healthy children and adolescents, aged 3 to 15 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children and adolescents (3-15 years) undergoing gait analysis | Experimental | Procedure: Gait analysis with surface electromyography (EMG) |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child/adolescent aged 3 to 15 years who has given assent, and whose parents (or legal representative) have provided consent to participate in this study.
- Affiliation with a social security system or beneficiary of such a system.
Key exclusion criteria (3 listed)
- Any known pathology affecting gait pattern (lower limbs, upper limbs, or spine).
- History of orthopedic surgery.
- Behavioral disorder incompatible with data collection.
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 |
|---|---|---|
| Gait analysis with surface electromyography (EMG)Each participant undergoes a standardized gait analysis session. After skin preparation, 28 surface electrodes are placed bilaterally on seven lower limb muscles. The child completes 10 walking trials (five round trips of 10 meters) at a comfortable, self-selected speed while being recorded by synchronized cameras. Data collected include Electromyography signals and video recordings. This procedure is non-invasive and performed in a single session lasting approximately one hour | Procedure or surgery | Healthy children and adolescents (3-15 years) undergoing gait analysis |
Primary outcome
Normative Kerpape Gait Index-Kids (Ker-EGI Kids) in children
Time frame: Single session per participant (~1 hour)
Establishment of a reference database for the Ker-EGI Kids, a gait quantification index based on lower limb muscle activation profiles in children aged 3 to 15 years. The primary outcome is the mean Ker-EGI Kids profile and its variability, with a maximum margin of error of 10%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis with surface electromyography (EMG) in people with Healthy Volunteers and Normal Gait, run by Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape 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 2 inclusion and 3 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative Kerpape Gait Index-Kids (Ker-EGI Kids) in children (time frame: Single session per participant (~1 hour)). 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.