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Trial record 1 of 1 for:    NCT00887848
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Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy (PeLoGAIT)

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ClinicalTrials.gov Identifier: NCT00887848
Recruitment Status : Terminated (Recruitment problems)
First Posted : April 24, 2009
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Reha Rheinfelden
Information provided by (Responsible Party):
University Children's Hospital, Zurich

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Last Update Posted Date March 30, 2018
Actual Study Start Date  ICMJE October 5, 2009
Actual Primary Completion Date August 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
GMFM-66, section E [ Time Frame: week 0, week 6, week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
  • GMFM-66, section D [ Time Frame: week 0, week 6, week 12 ]
  • Gait speed [ Time Frame: week 0, week 6, week 12 ]
  • 6-minute walk test [ Time Frame: week 0, week 6, week 12 ]
  • 3D gait analysis [ Time Frame: week 0, week 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
Official Title  ICMJE Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE Other: Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
Study Arms  ICMJE
  • Experimental: Lokomat training
    Lokomat training
    Intervention: Other: Lokomat training
  • Waiting list
    Lokomat training after waiting phase of 5 weeks
    Intervention: Other: Lokomat training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2009)
24
Actual Study Completion Date  ICMJE August 14, 2017
Actual Primary Completion Date August 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00887848
Other Study ID Numbers  ICMJE PeLoGAIT_2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Children's Hospital, Zurich
Study Sponsor  ICMJE University Children's Hospital, Zurich
Collaborators  ICMJE Reha Rheinfelden
Investigators  ICMJE
Principal Investigator: Corinne Ammann-Reiffer, MPTSc University Children's Hospital Zurich, Rehabilitation Center Affoltern
PRS Account University Children's Hospital, Zurich
Verification Date March 2018

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