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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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CP (Cerebral Palsy)

Intervention / Treatment
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* Device: PC Innowalk
* Device: Conventional passive stander


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br> <br> |
| Other: Control<br>Group of communicating CP children receiving a 30 minutes daily session of verticalization with their conventional passive stander. | Device: Conventional passive stander<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of pain according to the scale PPP (paediatric pain profile) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower limb muscular strength measured by the Ashworth scale |  | 6 weeks | 
| Lower limb articular amplitudes measured by a goniometer |  | 6 weeks | 
| Selective motor control measured by the CMS/Boyd scale |  | 6 weeks | 
| Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system |  | 6 weeks | 
| Identification and quantification (percentage) of adverse events and complications linked to the verticalization system |  | 6 weeks | 
| Number of days of utilization of the verticalization system until first complication or withdrawal of the study. |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motorized Orthotic Devices, Minors, CP (Cerebral Palsy), Exoskeleton Device