Clinical trial NCT04129749: Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.
Official title: Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cerebral Palsy
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cerebral palsy patients

Brief summary: 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Measure of energy cost during walk in cerebral palsy patients, by evolution of inter-segmental angle
timeFrame: at baseline Day 0
measure: Measure of energy cost during walk in cerebral palsy patients, by evolution of articular force
timeFrame: at baseline Day 0
measure: Measure of energy cost during walk in cerebral palsy patients by evolution of articular moment
timeFrame: at baseline Day 0
measure: Measure of energy cost during walk in cerebral palsy patients by evolution of articular power
timeFrame: at baseline Day 0
Secondary outcomes:
measure: quantification of biomechanical factors during walking by evolution of inter-segmental angles
timeFrame: at baseline Day 0
measure: quantification of biomechanical factors during walking by evolution of articular force
timeFrame: at baseline Day 0
measure: quantification of biomechanical factors during walking by evolution of articular moment
timeFrame: at baseline Day 0
measure: quantification of biomechanical factors during walking by evolution of of articular power
timeFrame: at baseline Day 0
measure: measure of physiological factors during walking by evolution of oxygen consummation
timeFrame: at baseline Day 0
measure: measure of physiological factors during walking by evolution of carbon dioxide consummation
timeFrame: at baseline Day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
affiliation: Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
name: RAMPAL Virginie, MD
role: PRINCIPAL_INVESTIGATOR
References: