Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM
- Conditions
- Infantile Hemiplegia
- Interventions
- Other: classical physiotherapyOther: Intensive robotic rehabilitation
- Registration Number
- NCT04246788
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 : controle group classical physiotherapy 3 sessions per week of 30 minutes of classical physiotherapy during two weeks Cohort 1 : experimental group Intensive robotic rehabilitation 5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks
- Primary Outcome Measures
Name Time Method Gait speed day 51 gait speed assessed during a gait assessment session using the GRAIL system
- Secondary Outcome Measures
Name Time Method quality of sleep: wristband actimeter day 51 quality of sleep per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours
number of steps per 24h day 51 Number of steps per 24h, measured using a wristband actimeter which will be given to each child for 24 hours
motor functions day 51 Overall motor function evaluated with the EMFG
travelled distance day 51 distance traveled per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours
6 min. walk test (6-WT) day 51 endurance evaluation by 6 min. walk test (6-WT)
joint angles day 51 Joint amplitudes measured during gait assessment with the GRAIL
Evaluation of spasticity day 51 Evaluation of spasticity by the modified Ashworth scale
Body composition measurements day 51 lean body mass
functional independence day 51 Overall functional independence assessed with the MIF-Môme autonomy scale
brain activated areas day 51 Functional brain connectivity analyzes by functional brain MRI
cardiac frequency day 51 heart rate per 24 hours, per 24h, measured using a wristband actimeter which will be given to each child for 24 hours
muscular strength day 51 Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing
Trial Locations
- Locations (1)
CHU Clermont Ferrand
🇫🇷Clermont-Ferrand, Auvergne, France