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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
IEM Sévigné
Béthune, Hauts-de-France, France
IEM Vent de Bise
Liévin, Hauts-de-France, France
IEM Christian Dabbadie
Villeneuve-d'Ascq, Hauts-de-France, France
IEM Ellen Poidatz
Saint-Fargeau-Ponthierry, France
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.
Time frame: 6 weeks
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.
Time frame: 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.
Time frame: 6 weeks
Selective motor control measured by the CMS/Boyd scale
Evaluation of selective motor control using the CMS/Boyd scale.
Time frame: 6 weeks
Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system
Heart rate
Time frame: 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
Time frame: 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
Time frame: 6 weeks
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