Clinical trial NCT02669160: Tolerance of a Motorized Orthosis Reproducing Walking Movement vs Conventional Standing-up Devices in Child With CP
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CP (Cerebral Palsy)
Keywords: Motorized Orthotic Devices
Minors
CP (Cerebral Palsy)
Exoskeleton Device
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Région Nord-Pas de Calais, France
name: Initiatives de parents de Jeunes Epileptiques du Nord
name: Unité de Traitement des Signaux Biomédicaux - HEI
name: Made for Movement
First posted: 2016-01-29
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tolerance of pain according to the scale PPP (paediatric pain profile)
timeFrame: 6 weeks
Secondary outcomes:
measure: Lower limb muscular strength measured by the Ashworth scale
timeFrame: 6 weeks
measure: Lower limb articular amplitudes measured by a goniometer
timeFrame: 6 weeks
measure: Selective motor control measured by the CMS/Boyd scale
timeFrame: 6 weeks
measure: Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system
timeFrame: 6 weeks
measure: Identification and quantification (percentage) of adverse events and complications linked to the verticalization system
timeFrame: 6 weeks
measure: Number of days of utilization of the verticalization system until first complication or withdrawal of the study.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Béthune
country: France
facility: IEM Sévigné
state: Nord Pas-de-Calais
city: Liévin
country: France
facility: IEM Vent de Bise
state: Nord Pas-de-Calais
city: Villeneuve d'Ascq
country: France
facility: IEM Christian Dabbadie
state: Nord Pas-de-Calais
city: Saint-Fargeau-Ponthierry
country: France
facility: IEM Ellen Poidatz
Study officials:
affiliation: GHICL
name: Jean-François Catanzariti, MD
role: PRINCIPAL_INVESTIGATOR
References: