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

This study is currently recruiting participants.
Verified February 2013 by University Children's Hospital, Zurich
Sponsor:
Collaborator:
Zurich University of Applied Sciences (ZHAW)
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT00887848
First received: April 23, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Cerebral Palsy
 Other: Lokomat training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • GMFM-66, section E [ Time Frame: week 0, week 6, week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lokomat training
Lokomat training
 Other: Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
Waiting list
Lokomat training after waiting phase of 5 weeks
 Other: Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)

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 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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887848

Contacts
Contact: Corinne Ammann-Reiffer, MPTSc +41447625297 corinne.ammann@kispi.uzh.ch

Locations
Switzerland
University Children's Hospital Zurich, Rehabilitation Centre Affoltern Recruiting
Affoltern am Albis, Switzerland, CH-8910
Principal Investigator: Corinne Ammann-Reiffer, MPTSc            
Sponsors and Collaborators
University Children's Hospital, Zurich
Zurich University of Applied Sciences (ZHAW)
Investigators
Principal Investigator: Corinne Ammann-Reiffer, MPTSc University Children's Hospital Zurich, Rehabilitation Center Affoltern
  More Information

Additional Information:
Homepage of the rehabilitation centre Affoltern am Albis, University Children's Hospital Zurich  This link exits the ClinicalTrials.gov site
Research projects at the rehabilitation centre Affoltern am Albis, University Children's Hospital Zurich  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT00887848     History of Changes
Other Study ID Numbers: PeLoGAIT_2009
Study First Received: April 23, 2009
Last Updated: February 21, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital, Zurich:
Child
Robotic-assisted treadmill training
Rehabilitation

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013