Clinical trial NCT04246788: Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM
Official title: Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Hemiplegia
Keywords: Infantile hemiplegia
Cerebral palsy
Intensive robotic rehabilitation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Université d'Auvergne
First posted: 2020-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy is the most frequent motor deficiency in children. Among other, it can leads to spastic diplegia or hemiplegia. Walking abilities is an important skill to the families' point of view in term of independence in curent life. Improving the walking parameters has been the main objective in several studies of rehabilitation. The G-EO system is a last generation robot assisting gait training that can adjust cadence, walk lengh, ankle and hip angles and other walking parameters to movement captation. Its superiority in terms of walking abilities has been demonstrated in adults with stroke sequelae. Only one study was realized in pediatric patients with spastic diplegia with promising results. The investigators hypothesize that intensive robot-assited gait training using the G-EO system in hemiplegic children can improve their walking abilities.

Detailed description: Objective :

Primary objective: To evaluate walking velocity with the GRAIL (gait real-time analysis and interactive lab) after intensive robot-assisted gait training using the G-EO system in hemiplegic children.

Secondary objectives :Other parameters that will be evaluate include:

* Endurance on the 6 minute walking test
* Joint angles and muscular contraction on the GRAIL
* Number of steps and travelled distance /24h, cardiac frequency and quality of sleep using actimeter bracelet
* Motor functions using the GMFM (Gross Motor Function Measure)
* Spasticity using the modified Ashworth scale
* The functional independence using the Functional Independence Measure (FIM™) for children,
* The quality of life using the Patient Global Impression (PGI-I)
* Muscular strength using the muscular testing cotation scale
* The musculo-squeletal and adipose composition using the peripherical quantitative computed tomography (pQCT)
* The cerebral area activation using functional MRI Study Type: Controlled randomized pilote study Number of centres: Monocentric study, University hospital of Clermont-Ferrand

Study procedure:

* Experimental group: 5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks
* Control group : 3 sessions per week of 30 minutes of classical physiotherapy during two weeks

Study evaluation:

T0 : before rehabilitation :

* Actimeter for 24h
* 6 min walking test
* GRAIL
* Modified Ashworth scale
* FIM for children
* GMFM
* Muscular testing scale
* pQCT
* fMRI

T1 : one month after rehabilitation :

* idem T0
* PGI-I questionnary Principal judgement criteria: Walking velocity Secondary judgement criteria: endurance, joint angles, number of steps and travelled distance per 24h, quality of sleep, cardiac frequency, spasticity, functional independence, motor functions, muscular strength, musculo-squeletal and adipose composition, brain activated areas.

Number of subjects:

* 20 patients in the experimental group
* 20 patients in the control group All patients enrolled in the control group will benefit of the GEOsystem rehabilitation at the end of the protocole

Inclusion criteria:

Hemiplegic children aged from 4 to 18 years, with a GMFCS (Gross Motor Function Classification System) score between I and III with lower limb involvement. Children must walk alone with or without aid at least 10 meters, must have acquired sitting position, must be able to understand simple orders to follow the rehabilitation program.

Non inclusion criteria:

No lower limb involvement, spasticity = 4 on the modified Ashworth scale, severe cardiorespiratory disease forbidding the rehabilitation program, orthopedic surgery or botulinic toxin injections in the last 6 months before the beginning of the study.

Study calendar:

* Starting inclusions: March 2020
* Experimental procedure: March 2020 to March 2021
* Data analyses and synthesis: April 2021 to Dember 2021

Statistical analyses Statistical analysis will be performed using Stata 13 software (Stata-Corp, College Station, TX) by an experimented statistician (Bruno Pereira) working in the university hospital of Clermont-Ferrand. A type-I error set at α=0.05 will be considered. Monovariate and multivariate analyses considering age as a covariable will be performed.

Ethical considerations This study has already been presented at the local ethical committee and will be presented in July 2019 at the national " comité de protection des personnes ". Written informed consent from both parents will be collected at the inclusion. This study will be in agreement with the declaration of Helsinki and the current regulations of clinical trials. It will be declared on the internet site "clinicaltrials.gov".

Expected results :

Intensive robot-assisted gait training using the G-EO system may improve the walking abilities in children with infantile hemiplegia and consequently improve their independence and quality of life. Musculo-squeletal parameters and profile of cerebral activated areas involved in praxia may also be modified by this intensive rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Hemiplegic children aged from 4 to 18 years
* GMFCS (Gross Motor Function Classification System) score between I and III with lower limb involvement.
* Children must walk alone with or without aid at least 10 meters, must have acquired sitting position, must be able to understand simple orders to follow the rehabilitation program.
* Free and informed consent of holders of parental authority and of the patient
* Affiliated to the social security system

Exclusion Criteria:

* No lower limb involvement,
* spasticity = 4 on the modified Ashworth scale,
* severe cardiorespiratory disease forbidding the rehabilitation program,
* orthopedic surgery or botulinic toxin injections in the last 6 months before the beginning of the study.

Primary outcomes:
measure: Gait speed
timeFrame: day 1
measure: Gait speed
timeFrame: day 21
measure: Gait speed
timeFrame: day 51
Secondary outcomes:
measure: 6 min. walk test (6-WT)
timeFrame: day 1
measure: 6 min. walk test (6-WT)
timeFrame: day 21
measure: 6 min. walk test (6-WT)
timeFrame: day 51
measure: joint angles
timeFrame: day 1
measure: joint angles
timeFrame: day 21
measure: joint angles
timeFrame: day 51
measure: number of steps per 24h
timeFrame: day 1
measure: number of steps per 24h
timeFrame: day 21
measure: number of steps per 24h
timeFrame: day 51
measure: travelled distance
timeFrame: day 1
measure: travelled distance
timeFrame: day 21
measure: travelled distance
timeFrame: day 51
measure: quality of sleep: wristband actimeter
timeFrame: day 1
measure: quality of sleep: wristband actimeter
timeFrame: day 21
measure: quality of sleep: wristband actimeter
timeFrame: day 51
measure: cardiac frequency
timeFrame: day 1
measure: cardiac frequency
timeFrame: day 21
measure: cardiac frequency
timeFrame: day 51
measure: Evaluation of spasticity
timeFrame: day 1
measure: Evaluation of spasticity
timeFrame: day 21
measure: Evaluation of spasticity
timeFrame: day 51
measure: functional independence
timeFrame: day 1
measure: functional independence
timeFrame: day 21
measure: functional independence
timeFrame: day 51
measure: motor functions
timeFrame: day 1
measure: motor functions
timeFrame: day 21
measure: motor functions
timeFrame: day 51
measure: muscular strength
timeFrame: day 1
measure: muscular strength
timeFrame: day 21
measure: muscular strength
timeFrame: day 51
measure: Body composition measurements
timeFrame: day 21
measure: Body composition measurements
timeFrame: day 51
measure: Body composition measurements
timeFrame: day 21
measure: Body composition measurements
timeFrame: day 51
measure: brain activated areas
timeFrame: day 21
measure: brain activated areas
timeFrame: day 51
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Catherine Sarret
role: PRINCIPAL_INVESTIGATOR
References: