Tolerance of a Motorized Orthosis Reproducing Walking Movement vs Conventional Standing-up Devices in Child With CP (EOMEC/CP)

Tolerance of a Motorized Orthosis Reproducing Walking Movement Versus Conventional Passive Standing-up Devices in Children With Cerebral Palsy : A Non-inferiority, Randomised, Multicenter, Controlled Trial

Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.

In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.

This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.

Study Overview

• Status: Terminated
• Conditions: CP (Cerebral Palsy)
• Intervention / Treatment: Device: PC Innowalk; Device: Conventional passive stander

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Fargeau-Ponthierry, France, 77310
    • IEM Ellen Poidatz
  • Hauts-de-France
    • Béthune, Hauts-de-France, France, 62400
      • IEM Sévigné
    • Liévin, Hauts-de-France, France, 62803
      • IEM Vent de Bise
    • Villeneuve-d'Ascq, Hauts-de-France, France, 59653
      • IEM Christian Dabbadie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CP children from 6 to 16 years old, and being less than 150 cms, able to receive a 30 minutes verticalization session (standard practice) without sign of discomfort or intolerance
• Communicating children
• Children who had never walked

Exclusion Criteria:

• Children presenting uncontrolled epileptic seizures
• No social insurance affiliation
• Refuse to participate in the study
• Orthopaedic surgery in 6 months which precede the inclusion.
• Injection of botulinum toxin in the 6 months which precede the inclusion.
• Previous neurotomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Group of communicating CP children receiving a 30 minutes daily session of verticalization with a motorized orthosis reproducing walking movement (PS Innowalk)	Device: PC Innowalk
Other: Control; Group of communicating CP children receiving a 30 minutes daily session of verticalization with their conventional passive stander.	Device: Conventional passive stander

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of pain according to the scale PPP (paediatric pain profile)	Paediatric Pain Profile (PPP) pain scale, validated for children with CP and completed by the carer (hetero questionnaire), assessed at D0, D1, W3 and W6.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb muscular strength measured by the Ashworth scale	Ashworth muscle tone scale (assessment of spasticity). This validated scale is used to test the muscular reaction to stretching.	6 weeks
Lower limb articular amplitudes measured by a goniometer	Assessment of joint amplitudes using goniometry. This passive assessment will be carried out for the ankle, knee and hip joints.	6 weeks
Selective motor control measured by the CMS/Boyd scale	Evaluation of selective motor control using the CMS/Boyd scale.	6 weeks
Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system	Heart rate	6 weeks
Identification and quantification (percentage) of adverse events and complications linked to the verticalization system	Number of complications (epileptic seizures, lesions, fractures, malaise, etc.) occurring during the study, description of these, severity grade, evolution, responsibility of the equipment, etc	6 weeks
Number of days of utilization of the verticalization system until first complication or withdrawal of the study.	Time of use of device until first complication Time in use of device until discontinuation due to complication	6 weeks

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Région Nord-Pas de Calais, France; Made for Movement; Initiatives de parents de Jeunes Epileptiques du Nord; Unité de Traitement des Signaux Biomédicaux - HEI
• Investigators: Principal Investigator: Jean-François Catanzariti, MD, GHICL

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 18, 2018

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimated): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Exoskeleton Device; Minors; CP (Cerebral Palsy); Motorized Orthotic Devices
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: RC-P0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO