Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

Conditions
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Infantile Hemiplegia

Intervention / Treatment
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* Other: Intensive robotic rehabilitation
* Other: classical physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 : experimental group<br>5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks | Other: Intensive robotic rehabilitation<br>* 5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks<br>|
| Active Comparator: Cohort 2 : controle group<br>3 sessions per week of 30 minutes of classical physiotherapy during two weeks | Other: classical physiotherapy<br>* 3 sessions per week of 30 minutes of classical physiotherapy during two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | gait speed assessed during a gait assessment session using the GRAIL system | day 1 | 
| Gait speed | gait speed assessed during a gait assessment session using the GRAIL system | day 21 | 
| Gait speed | gait speed assessed during a gait assessment session using the GRAIL system | day 51 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 min. walk test (6-WT) | endurance evaluation by 6 min. walk test (6-WT) | day 1 | 
| 6 min. walk test (6-WT) | endurance evaluation by 6 min. walk test (6-WT) | day 21 | 
| 6 min. walk test (6-WT) | endurance evaluation by 6 min. walk test (6-WT) | day 51 | 
| joint angles | Joint amplitudes measured during gait assessment with the GRAIL | day 1 | 
| joint angles | Joint amplitudes measured during gait assessment with the GRAIL | day 21 | 
| joint angles | Joint amplitudes measured during gait assessment with the GRAIL | day 51 | 
| number of steps per 24h | Number of steps per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 1 | 
| number of steps per 24h | Number of steps per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 21 | 
| number of steps per 24h | Number of steps per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 51 | 
| travelled distance | distance traveled per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 1 | 
| travelled distance | distance traveled per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 21 | 
| travelled distance | distance traveled per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 51 | 
| quality of sleep: wristband actimeter | quality of sleep per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 1 | 
| quality of sleep: wristband actimeter | quality of sleep per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 21 | 
| quality of sleep: wristband actimeter | quality of sleep per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 51 | 
| cardiac frequency | heart rate per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 1 | 
| cardiac frequency | heart rate per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 21 | 
| cardiac frequency | heart rate per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours | day 51 | 
| Evaluation of spasticity | Evaluation of spasticity by the modified Ashworth scale | day 1 | 
| Evaluation of spasticity | Evaluation of spasticity by the modified Ashworth scale | day 21 | 
| Evaluation of spasticity | Evaluation of spasticity by the modified Ashworth scale | day 51 | 
| functional independence | Overall functional independence assessed with the MIF-Môme autonomy scale | day 1 | 
| functional independence | Overall functional independence assessed with the MIF-Môme autonomy scale | day 21 | 
| functional independence | Overall functional independence assessed with the MIF-Môme autonomy scale | day 51 | 
| motor functions | Overall motor function evaluated with the EMFG | day 1 | 
| motor functions | Overall motor function evaluated with the EMFG | day 21 | 
| motor functions | Overall motor function evaluated with the EMFG | day 51 | 
| muscular strength | Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing | day 1 | 
| muscular strength | Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing | day 21 | 
| muscular strength | Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing | day 51 | 
| Body composition measurements | fat body mass | day 21 | 
| Body composition measurements | fat body mass | day 51 | 
| Body composition measurements | lean body mass | day 21 | 
| Body composition measurements | lean body mass | day 51 | 
| brain activated areas | Functional brain connectivity analyzes by functional brain MRI | day 21 | 
| brain activated areas | Functional brain connectivity analyzes by functional brain MRI | day 51 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infantile hemiplegia, Cerebral palsy, Intensive robotic rehabilitation