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Tolerance of a Motorized Orthosis Reproducing Walking Movement vs Conventional Standing-up Devices in Child With 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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02669160
Acronym
EOMEC/CP
Enrollment
25
Registered
2016-01-29
Start date
2015-11-01
Completion date
2018-11-18
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CP (Cerebral Palsy)

Keywords

Motorized Orthotic Devices, Minors, CP (Cerebral Palsy), Exoskeleton Device

Brief summary

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.

Interventions

DEVICEPC Innowalk
DEVICEConventional passive stander

Sponsors

Lille Catholic University
Lead SponsorOTHER
Région Nord-Pas de Calais, France
CollaboratorOTHER
Initiatives de parents de Jeunes Epileptiques du Nord
CollaboratorUNKNOWN
Unité de Traitement des Signaux Biomédicaux - HEI
CollaboratorUNKNOWN
Made for Movement
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tolerance of pain according to the scale PPP (paediatric pain profile)6 weeksPaediatric Pain Profile (PPP) pain scale, validated for children with CP and completed by the carer (hetero questionnaire), assessed at D0, D1, W3 and W6.

Secondary

MeasureTime frameDescription
Lower limb muscular strength measured by the Ashworth scale6 weeksAshworth muscle tone scale (assessment of spasticity). This validated scale is used to test the muscular reaction to stretching.
Lower limb articular amplitudes measured by a goniometer6 weeksAssessment of joint amplitudes using goniometry. This passive assessment will be carried out for the ankle, knee and hip joints.
Selective motor control measured by the CMS/Boyd scale6 weeksEvaluation of selective motor control using the CMS/Boyd scale.
Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system6 weeksHeart rate
Identification and quantification (percentage) of adverse events and complications linked to the verticalization system6 weeksNumber of complications (epileptic seizures, lesions, fractures, malaise, etc.) occurring during the study, description of these, severity grade, evolution, responsibility of the equipment, etc
Number of days of utilization of the verticalization system until first complication or withdrawal of the study.6 weeksTime of use of device until first complication Time in use of device until discontinuation due to complication

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-François Catanzariti, MD

GHICL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026