Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

NCT ID: NCT04246788

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2021-11-24

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.

Conditions

Infantile Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 : experimental group

5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks

Group Type: EXPERIMENTAL

Intensive robotic rehabilitation

Intervention Type: OTHER

5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks

Cohort 2 : controle group

3 sessions per week of 30 minutes of classical physiotherapy during two weeks

Group Type: ACTIVE_COMPARATOR

classical physiotherapy

Intervention Type: OTHER

3 sessions per week of 30 minutes of classical physiotherapy during two weeks

Interventions

Intensive robotic rehabilitation

5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks

Intervention Type: OTHER

classical physiotherapy

3 sessions per week of 30 minutes of classical physiotherapy during two weeks

Intervention Type: OTHER

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université d'Auvergne

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Sarret

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont Ferrand

Clermont-Ferrand, Auvergne, France

Countries

France

Other Identifiers

2019-A02218-49

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 SARRET

Identifier Type: -

Identifier Source: org_study_id