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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

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Lokomat training Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Actual Study Start Date : October 5, 2009
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. GMFM-66, section E [ Time Frame: week 0, week 6, week 12 ]

Secondary Outcome Measures :
  1. GMFM-66, section D [ Time Frame: week 0, week 6, week 12 ]
  2. Gait speed [ Time Frame: week 0, week 6, week 12 ]
  3. 6-minute walk test [ Time Frame: week 0, week 6, week 12 ]
  4. 3D gait analysis [ Time Frame: week 0, week 6 ]


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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)

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


Locations
Switzerland
Paediatric Therapy Center Reha Rheinfelden
Rheinfelden, Aargau, Switzerland, CH-4310
University Children's Hospital Zurich, Rehabilitation Centre Affoltern
Affoltern am Albis, Switzerland, CH-8910
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT00887848     History of Changes
Other Study ID Numbers: PeLoGAIT_2009
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
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