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

March 28, 2018 updated by: University Children's Hospital, Zurich

Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lokomat training
Other: Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
Other: Waiting list
Lokomat training after waiting phase of 5 weeks
Other: Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GMFM-66, section E
Time Frame: week 0, week 6, week 12
week 0, week 6, week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
GMFM-66, section D
Time Frame: week 0, week 6, week 12
week 0, week 6, week 12
Gait speed
Time Frame: week 0, week 6, week 12
week 0, week 6, week 12
6-minute walk test
Time Frame: week 0, week 6, week 12
week 0, week 6, week 12
3D gait analysis
Time Frame: week 0, week 6
week 0, week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Collaborators

Reha Rheinfelden

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2009

Primary Completion (Actual)

August 14, 2017

Study Completion (Actual)

August 14, 2017

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PeLoGAIT_2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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