Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy - Full Text View

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

This study is not yet open for participant recruitment.

Verified by University Children's Hospital, Zurich, April 2009

First Received: April 23, 2009 No Changes Posted

Sponsors and Collaborators:	University Children's Hospital, Zurich University Children's Hospital Basel
Information provided by:	University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:	NCT00887848

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

MedlinePlus related topics: Cerebral Palsy Paralysis Rehabilitation

U.S. FDA Resources

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

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:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lokomat training: Experimental	Other: Lokomat training 15 sessions of Lokomat training within 5 weeks (3 trainings/week)
Waiting list: No Intervention

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)
Significant mental retardation
Severe contractures

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
Rehabilitation Centre, University Children's Hospital Zurich
Affoltern am Albis, Switzerland, CH-8910

Sponsors and Collaborators

University Children's Hospital, Zurich

University Children's Hospital Basel

Investigators

Principal Investigator:

Corinne Ammann-Reiffer, MPTSc

Rehabilitation Centre Affoltern am Albis, University Children's Hospital Zurich

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:	Rehabilitation Centre Affoltern am Albis, University Children's Hospital Zurich ( Corinne Ammann-Reiffer )
Study ID Numbers:	PeLoGAIT_2009
Study First Received:	April 23, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00887848 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:

Child
Robotic-assisted treadmill training
Rehabilitation

Study placed in the following topic categories:

Paralysis
Cerebral Palsy
Brain Damage, Chronic

Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 06, 2009