Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

Infantile Hemiplegia Clinical Trial

— RIPHIGEO  

Official title:

Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246788
• Other study ID #: RBHP 2019 SARRET
• Secondary ID: 2019-A02218-49
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: November 24, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Infantile Hemiplegia

Intervention

Other:
• Intensive robotic rehabilitation
5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks
• classical physiotherapy
3 sessions per week of 30 minutes of classical physiotherapy during two weeks

Locations

Country	Name	City	State
France	CHU Clermont Ferrand	Clermont-Ferrand	Auvergne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	gait speed assessed during a gait assessment session using the GRAIL system	day 1
Primary	Gait speed	gait speed assessed during a gait assessment session using the GRAIL system	day 21
Primary	Gait speed	gait speed assessed during a gait assessment session using the GRAIL system	day 51
Secondary	6 min. walk test (6-WT)	endurance evaluation by 6 min. walk test (6-WT)	day 1
Secondary	6 min. walk test (6-WT)	endurance evaluation by 6 min. walk test (6-WT)	day 21
Secondary	6 min. walk test (6-WT)	endurance evaluation by 6 min. walk test (6-WT)	day 51
Secondary	joint angles	Joint amplitudes measured during gait assessment with the GRAIL	day 1
Secondary	joint angles	Joint amplitudes measured during gait assessment with the GRAIL	day 21
Secondary	joint angles	Joint amplitudes measured during gait assessment with the GRAIL	day 51
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of spasticity	Evaluation of spasticity by the modified Ashworth scale	day 1
Secondary	Evaluation of spasticity	Evaluation of spasticity by the modified Ashworth scale	day 21
Secondary	Evaluation of spasticity	Evaluation of spasticity by the modified Ashworth scale	day 51
Secondary	functional independence	Overall functional independence assessed with the MIF-Môme autonomy scale	day 1
Secondary	functional independence	Overall functional independence assessed with the MIF-Môme autonomy scale	day 21
Secondary	functional independence	Overall functional independence assessed with the MIF-Môme autonomy scale	day 51
Secondary	motor functions	Overall motor function evaluated with the EMFG	day 1
Secondary	motor functions	Overall motor function evaluated with the EMFG	day 21
Secondary	motor functions	Overall motor function evaluated with the EMFG	day 51
Secondary	muscular strength	Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing	day 1
Secondary	muscular strength	Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing	day 21
Secondary	muscular strength	Muscle strength will be measured with a quotation scale (1 to 5) for manual muscle testing	day 51
Secondary	Body composition measurements	fat body mass	day 21
Secondary	Body composition measurements	fat body mass	day 51
Secondary	Body composition measurements	lean body mass	day 21
Secondary	Body composition measurements	lean body mass	day 51
Secondary	brain activated areas	Functional brain connectivity analyzes by functional brain MRI	day 21
Secondary	brain activated areas	Functional brain connectivity analyzes by functional brain MRI	day 51