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

NCT02669160 | Completed

• 1 other identifier: RC-P0032
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

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.

Conditions

CP (Cerebral Palsy)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

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

Control

OTHER

Group of communicating CP children receiving a 30 minutes daily session of verticalization with their conventional passive stander.

Device: Conventional passive stander

Interventions

PC Innowalk DEVICE

Experimental

Conventional passive stander DEVICE

Control

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children presenting uncontrolled epileptic seizures
• No social insurance affiliation
• Refuse to participate in the study
• Previous neurotomy

Sponsors & Collaborators

• Lille Catholic University: lead
• Région Nord-Pas de Calais, France: collaborator
• Initiatives de parents de Jeunes Epileptiques du Nord: collaborator
• Unité de Traitement des Signaux Biomédicaux - HEI: collaborator
• Made for Movement: collaborator

Study Sites (4)

IEM Sévigné

Béthune, Hauts-de-France, 62400, France

Location

IEM Vent de Bise

Liévin, Hauts-de-France, 62803, France

Location

IEM Christian Dabbadie

Villeneuve-d'Ascq, Hauts-de-France, 59653, France

Location

IEM Ellen Poidatz

Saint-Fargeau-Ponthierry, 77310, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jean-François Catanzariti, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 18, 2018
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)