- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00887848
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy (PeLoGAIT)
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Affoltern am Albis, Switzerland, CH-8910
- University Children's Hospital Zurich, Rehabilitation Centre Affoltern
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Aargau
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Rheinfelden, Aargau, Switzerland, CH-4310
- Paediatric Therapy Center Reha Rheinfelden
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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15 sessions of Lokomat training within 5 weeks (3 trainings/week)
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Other: Waiting list
Lokomat training after waiting phase of 5 weeks
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15 sessions of Lokomat training within 5 weeks (3 trainings/week)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
GMFM-66, section E
Time Frame: week 0, week 6, week 12
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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
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Gait speed
Time Frame: week 0, week 6, week 12
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week 0, week 6, week 12
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6-minute walk test
Time Frame: week 0, week 6, week 12
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week 0, week 6, week 12
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3D gait analysis
Time Frame: week 0, week 6
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week 0, week 6
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Corinne Ammann-Reiffer, MPTSc, University Children's Hospital Zurich, Rehabilitation Center Affoltern
Publications and helpful links
General Publications
- Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.
- Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PeLoGAIT_2009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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