Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy

NCT ID: NCT00887848

Last Updated: 2018-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-05

Study Completion Date

2017-08-14

Brief Summary

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The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy.

Detailed Description

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Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 34 children with cerebral palsy.

Children will be randomly assigned to an intervention or waiting list group. Assessments will be performed at baseline, in week 6 as well as in week 12. The intervention is provided to the waiting list group after the assessment in week 6.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Lokomat training

Lokomat training

Group Type EXPERIMENTAL

Lokomat training

Intervention Type OTHER

15 sessions of Lokomat training within 5 weeks (3 trainings/week)

Waiting list

Lokomat training after waiting phase of 5 weeks

Group Type OTHER

Lokomat training

Intervention Type OTHER

15 sessions of Lokomat training within 5 weeks (3 trainings/week)

Interventions

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Lokomat training

15 sessions of Lokomat training within 5 weeks (3 trainings/week)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Bilateral spastic cerebral palsy
* Gross Motor Function Classification Scale (GMFCS) II-IV

Exclusion Criteria

* Prior orthopedic surgery on the lower extremity or the trunk (\<6 months)
* Prior neurosurgical interventions (\<6 months)
* Significant mental retardation
* Severe contractures
* Prior Lokomat training (\<6 months)
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reha Rheinfelden

OTHER

Sponsor Role collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corinne Ammann-Reiffer, MPTSc

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Zurich, Rehabilitation Center Affoltern

Locations

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Paediatric Therapy Center Reha Rheinfelden

Rheinfelden, Canton of Aargau, Switzerland

Site Status

University Children's Hospital Zurich, Rehabilitation Centre Affoltern

Affoltern am Albis, , Switzerland

Site Status

Countries

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Switzerland

References

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Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.

Reference Type DERIVED
PMID: 32444573 (View on PubMed)

Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.

Reference Type DERIVED
PMID: 28253887 (View on PubMed)

Other Identifiers

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PeLoGAIT_2009

Identifier Type: -

Identifier Source: org_study_id

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