Creation of a Pediatric Reference Database for the Kerpape-Rennes-EMG-Based Gait Index

NCT07212257 | Completed

• 1 other identifier: 2024-A00178-39
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers; Normal Gait; Child Development; Gait; Normal Gait in Children; Pediatric Normative Gait Data

Outcome Measures

Primary Outcomes (1)

• 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%.

  Single session per participant (~1 hour)

Study Arms (1)

Healthy children and adolescents (3-15 years) undergoing gait analysis

EXPERIMENTAL

Procedure: Gait analysis with surface electromyography (EMG)

Interventions

Gait analysis with surface electromyography (EMG) PROCEDURE

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

Healthy children and adolescents (3-15 years) undergoing gait analysis

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Any known pathology affecting gait pattern (lower limbs, upper limbs, or spine).
• History of orthopedic surgery.
• Behavioral disorder incompatible with data collection.

Sponsors & Collaborators

• Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape: lead

Study Sites (1)

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape

Ploemeur, 56270, France

Location

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: April 17, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)