Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM (RIPHIGEO)

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.

Study Overview

• Status: Completed
• Conditions: Infantile Hemiplegia
• Intervention / Treatment: Other: Intensive robotic rehabilitation; Other: classical physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63000
      • CHU Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Université d'Auvergne
• Investigators: Principal Investigator: Catherine Sarret, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Cerebral palsy; Infantile hemiplegia; Intensive robotic rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: RBHP 2019 SARRET; 2019-A02218-49 (Other Identifier: 2019-A02218-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No