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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT02669160
• Date of registration: 27/01/2016
• Prospective Registration: No
• Primary sponsor: Lille Catholic University
• Public title: Tolerance of a Motorized Orthosis Reproducing Walking Movement vs Conventional Standing-up Devices in Child With CP EOMEC/CP
• Scientific 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
• Date of first enrolment: November 2015
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02669160
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Jean-François Catanzariti, MD
• Affiliation: GHICL

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

CP (Cerebral Palsy)

Intervention(s)

Device: PC Innowalk

Device: Conventional passive stander

Primary Outcome(s)

Tolerance of pain according to the scale PPP (paediatric pain profile) [Time Frame: 6 weeks]

Secondary Outcome(s)

Number of days of utilization of the verticalization system until first complication or withdrawal of the study. [Time Frame: 6 weeks]

Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system [Time Frame: 6 weeks]

Lower limb muscular strength measured by the Ashworth scale [Time Frame: 6 weeks]

Identification and quantification (percentage) of adverse events and complications linked to the verticalization system [Time Frame: 6 weeks]

Lower limb articular amplitudes measured by a goniometer [Time Frame: 6 weeks]

Selective motor control measured by the CMS/Boyd scale [Time Frame: 6 weeks]

Secondary ID(s)

RC-P0032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Initiatives de parents de Jeunes Epileptiques du Nord

Région Nord-Pas de Calais, France

Unité de Traitement des Signaux Biomédicaux - HEI

Made for Movement