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

This study is currently recruiting participants.
Verified November 2017 by University Children's Hospital, Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887848
First Posted: April 24, 2009
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Reha Rheinfelden
Information provided by (Responsible Party):
University Children's Hospital, Zurich
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 34
Study Start Date: May 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887848


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

Locations
Switzerland
Paediatric Therapy Center Reha Rheinfelden Recruiting
Rheinfelden, Aargau, Switzerland, CH-4310
Contact: Corina Schuster, PhD    0041 (0)61 836 53 81    c.schuster@reha-rhf.ch   
Contact: Corinne Messerli, PT    0041 (0)61 836 57 31    c.messerli@reha-rhf.ch   
University Children's Hospital Zurich, Rehabilitation Centre Affoltern Recruiting
Affoltern am Albis, Switzerland, CH-8910
Contact: Corinne Ammann, MPTSc    0041 44 762 52 97    corinne.ammann@kispi.uzh.ch   
Principal Investigator: Corinne Ammann-Reiffer, MPTSc         
Sponsors and Collaborators
University Children's Hospital, Zurich
Reha Rheinfelden
Investigators
Principal Investigator: Corinne Ammann-Reiffer, MPTSc University Children's Hospital Zurich, Rehabilitation Center Affoltern
  More Information

Additional Information:
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT00887848     History of Changes
Other Study ID Numbers: PeLoGAIT_2009
First Submitted: April 23, 2009
First Posted: April 24, 2009
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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