NCT04246788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 17, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2021

Completed
Last Updated

January 11, 2022

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

January 24, 2020

Last Update Submit

January 10, 2022

Conditions

Infantile Hemiplegia

Keywords

Infantile hemiplegiaCerebral palsyIntensive robotic rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (36)

  • 6 min. walk test (6-WT)

    day 1

  • 6 min. walk test (6-WT)

    day 21

  • 6 min. walk test (6-WT)

    day 51

  • joint angles

    day 1

  • joint angles

    day 21

  • +31 more secondary outcomes

Study Arms (2)

Cohort 1 : experimental group

EXPERIMENTAL

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

Other: Intensive robotic rehabilitation

Cohort 2 : controle group

ACTIVE COMPARATOR

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

Other: classical physiotherapy

Interventions

Intensive robotic rehabilitationOTHER

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

Cohort 1 : experimental group
classical physiotherapyOTHER

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

Cohort 2 : controle group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont Ferrand

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Conditions

HemiplegiaCerebral Palsy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Catherine Sarret

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 29, 2020

Study Start

July 17, 2020

Primary Completion

November 24, 2021

Study Completion

November 24, 2021

Last Updated

January 11, 2022

Record last verified: 2021-04

Locations

FR(1)