ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 82 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02669160
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
Région Nord-Pas de Calais, France
Initiatives de parents de Jeunes Epileptiques du Nord
Unité de Traitement des Signaux Biomédicaux - HEI
Made for movement
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment Phase
CP (Cerebral Palsy) Device: PC Innowalk Device: Conventional passive stander Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : December 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Group of communicating CP children receiving a 30 minutes daily session of verticalization with their conventional passive stander.
Device: Conventional passive stander



Primary Outcome Measures :
  1. Tolerance of pain according to the scale PPP (paediatric pain profile) [ Time Frame: 6 weeks ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669160


Contacts
Contact: Amélie Lansiaux, MD, PhD 0033320225269 lansiaux.amelie@ghicl.net
Contact: Olivier Agnani 03 20 22 50 47 agnani.olivier@ghicl.net

Locations
France
IEM Sévigné Not yet recruiting
Béthune, Nord Pas-de-Calais, France, 62400
Contact: Valérie Marianski, MD         
IEM Vent de Bise Completed
Liévin, Nord Pas-de-Calais, France, 62803
IEM Christian Dabbadie Completed
Villeneuve d'Ascq, Nord Pas-de-Calais, France, 59653
IEM Ellen Poidatz Recruiting
Saint-Fargeau-Ponthierry, France, 77310
Contact: Eric Dessailly, PhD         
Principal Investigator: Béatrice Bouyssou, MD         
Sponsors and Collaborators
Lille Catholic University
Région Nord-Pas de Calais, France
Initiatives de parents de Jeunes Epileptiques du Nord
Unité de Traitement des Signaux Biomédicaux - HEI
Made for movement
Investigators
Principal Investigator: Jean-François Catanzariti, MD GHICL

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02669160     History of Changes
Other Study ID Numbers: RC-P0032
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lille Catholic University:
Motorized Orthotic Devices
Minors
CP (Cerebral Palsy)
Exoskeleton Device

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases