Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.

To date, studies do not study the influence of external disturbing factors on the market.

The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.

The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).

This study will use the GRAIL combining an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment projected on a 180 ° screen

Study Overview

• Status: Withdrawn
• Conditions: Cerebral Palsy
• Intervention / Treatment: Procedure: Real-Time Analysis Interactive Lab

Detailed Description

In most studies, the study of the gait of cerebral palsy patients is done through quantified walking analysis tests, objectively evaluating the kinetic and kinematic parameters, associated with the measurement of respiratory exchanges and heart rate.

Nevertheless this very objective evaluation does not really reflect the child's ability to perform the acts of everyday life that he wishes, and in particular, his ability to walk a long time.

It therefore appears that patients do not only want to walk better on an objective and analytical level but also aim to walk longer and improve their walking efficiency.

To date, studies do not study the influence of external disturbing factors on the market.

The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.

The main objective is to confirm this hypothesis. The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).

For that, the investigators will use a tool that is perfectly adapted: the GRAIL (Real-Time Analysis Interactive Lab). The GRAIL uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment. Throughout the duration of the test, the investigators will quantify the evolution of biomechanical (kinematic, kinetic and EMG) and physiological (gas analysis system) factors during walking.

This is a study conducted in a usual evaluation framework: market analysis is commonly indicated for paralyzed children, in order to assess their disability and to propose the best therapy. There was no inherent risk in the proposed study protocol, but possible fatigue is inevitably analyzed, which is not related to inclusion in this study.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Hôpitaux Pédiatriques de Nice CHU-Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cerebral palsy patients

Description

Inclusion Criteria:

• children aged 7 to 18 years (diplegic, hemiparetic or tetraparetic) requiring treatment with botulinum toxin
• followed at the Lenval Foundation
• walking alone more than 6 minutes
• parental information and no disagreement

Exclusion Criteria:

• Modification of spasticity treatments within 6 months of evaluation: baclofen pump, oral baclofen, retraction surgery (tenotomy, tendon lengthening, arthrodesis ...)
• dyskinesia
• Cognitive disorders in children that do not allow the use of GRAIL
• Contraindication to Botulinum Toxin (myasthenia, hypersensitivity and infections)
• Contraindication to physical activity (intercurrent pathology)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Real-Time Analysis Interactive Lab; walk spontaneously or at prescribed speeds of cerebral palsy patient to a standstill in a virtual and secure virtual reality environment.	Procedure: Real-Time Analysis Interactive Lab; The Real-Time Analysis Interactive Lab uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of energy cost during walk in cerebral palsy patients, by evolution of inter-segmental angle	Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. This will be evaluated by the evolution of inter-segmental angles (degrees) during a 6 minutes walking test.	at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients, by evolution of articular force	Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular force (N/kg) during a 6 minutes walking test.	at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by evolution of articular moment	Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular moment (N.m/kg) during a 6 minutes walking test.	at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by evolution of articular power	Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular power (W/kg) during a 6 minutes walking test	at baseline Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantification of biomechanical factors during walking by evolution of inter-segmental angles	Measure of kinematic and kinetic parameters during walk in cerebral palsy patients. This will be evaluated by the evolution of inter-segmental angles (degrees) during a 6 minutes walking test.	at baseline Day 0
quantification of biomechanical factors during walking by evolution of articular force	Measure of kinematic and kinetic parameters during walk in cerebral palsy patients. This will be evaluated by the evolution of articular force (N/kg) during a 6 minutes walking test.	at baseline Day 0
quantification of biomechanical factors during walking by evolution of articular moment	Measure of kinematic and kinetic parameters during walk in cerebral palsy patients. This will be evaluated by the evolution of articular moment (N.m/kg) during a 6 minutes walking test.	at baseline Day 0
quantification of biomechanical factors during walking by evolution of of articular power	Measure of kinematic and kinetic parameters during walk in cerebral palsy patients. This will be evaluated by the evolution of of articular power (W/kg) during a 6 minutes walking test.	at baseline Day 0
measure of physiological factors during walking by evolution of oxygen consummation	measure of O2 consummation during walk in cerebral palsy patients by a gas system analysis. This will be evaluated by the evolution of O2 consummation during walk during a 6 minutes walking test.	at baseline Day 0
measure of physiological factors during walking by evolution of carbon dioxide consummation	measure of CO2 consummation during walk in cerebral palsy patients by a gas system analysis. This will be evaluated by the evolution of CO2 consummation during walk during a 6 minutes walking test..	at baseline Day 0

Collaborators and Investigators

• Sponsor: Fondation Lenval
• Investigators: Principal Investigator: RAMPAL Virginie, MD, Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 19-HPNCL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No