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Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy (PeLoGAIT)

This study is currently recruiting participants.
Verified May 2012 by University Children's Hospital, Zurich
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT00887848
First received: April 23, 2009
Last updated: May 29, 2012
Last verified: May 2012
History of Changes

April 23, 2009
May 29, 2012
May 2009
December 2013   (final data collection date for primary outcome measure)
GMFM-66, section E [ Time Frame: week 0, week 6, week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887848 on ClinicalTrials.gov Archive Site
  • GMFM-66, section D [ Time Frame: week 0, week 6, week 12 ] [ Designated as safety issue: No ]
  • Gait speed [ Time Frame: week 0, week 6, week 12 ] [ Designated as safety issue: No ]
  • 6-minute walk test [ Time Frame: week 0, week 6, week 12 ] [ Designated as safety issue: No ]
  • 3D gait analysis [ Time Frame: week 0, week 6 ] [ Designated as safety issue: No ]
Same as current
 
 
 
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis

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.

Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 24 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.
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Cerebral Palsy
Other: Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
  • Experimental: Lokomat training
    Intervention: Other: Lokomat training
  • No Intervention: Waiting list
    Intervention: Other: Lokomat training
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bilateral spastic cerebral palsy
  • Gross Motor Function Classification Scale (GMFCS) II-III

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)
Both
6 Years to 16 Years
No
Contact: Corinne Ammann-Reiffer, MPTSc +41447625297 corinne.ammann@kispi.uzh.ch
Switzerland
 
NCT00887848
PeLoGAIT_2009
No
University Children's Hospital, Zurich
University Children's Hospital, Zurich
University Children's Hospital Basel
Principal Investigator: Corinne Ammann-Reiffer, MPTSc University Children's Hospital Zurich, Rehabilitation Center Affoltern
University Children's Hospital, Zurich
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP