Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM
Condition: Infantile Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

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.
    

Intervention name(s): Intensive robotic rehabilitation; classical physiotherapy
Intervention type(s): Other; Other
Intervention description(s): 5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks; 3 sessions per week of 30 minutes of classical physiotherapy during two weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infantile hemiplegia; Cerebral palsy; Intensive robotic rehabilitation