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

This study is currently recruiting participants.
Verified March 2014 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT00887848
First received: April 23, 2009
Last updated: March 27, 2014
Last verified: March 2014
  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:


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
Investigators
Principal Investigator: Corinne Ammann-Reiffer, MPTSc University Children's Hospital Zurich, Rehabilitation Center Affoltern
  More Information

Additional Information:
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: March 27, 2014
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 April 16, 2014