Back to resultsEffectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy (PeLoGAIT)
Primary Purpose
Cerebral Palsy
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lokomat training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Child, Robotic-assisted treadmill training, Rehabilitation
Eligibility 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)
Sites / Locations
- Paediatric Therapy Center Reha Rheinfelden
- University Children's Hospital Zurich, Rehabilitation Centre Affoltern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Lokomat training
Waiting list
Arm Description
Lokomat training
Lokomat training after waiting phase of 5 weeks
Outcomes
Primary Outcome Measures
GMFM-66, section E
Secondary Outcome Measures
GMFM-66, section D
Gait speed
6-minute walk test
3D gait analysis
Full Information
NCT ID
NCT00887848
First Posted
April 23, 2009
Last Updated
March 28, 2018
Sponsor
University Children's Hospital, Zurich
Collaborators
Reha Rheinfelden
1. Study Identification
Unique Protocol Identification Number
NCT00887848
Brief Title
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
Acronym
PeLoGAIT
Official Title
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy: A Randomized Controlled Clinical Trial Including 3D Gait Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems
Study Start Date
October 5, 2009 (Actual)
Primary Completion Date
August 14, 2017 (Actual)
Study Completion Date
August 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
Collaborators
Reha Rheinfelden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Child, Robotic-assisted treadmill training, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lokomat training
Arm Type
Experimental
Arm Description
Lokomat training
Arm Title
Waiting list
Arm Type
Other
Arm Description
Lokomat training after waiting phase of 5 weeks
Intervention Type
Other
Intervention Name(s)
Lokomat training
Intervention Description
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
Primary Outcome Measure Information:
Title
GMFM-66, section E
Time Frame
week 0, week 6, week 12
Secondary Outcome Measure Information:
Title
GMFM-66, section D
Time Frame
week 0, week 6, week 12
Title
Gait speed
Time Frame
week 0, week 6, week 12
Title
6-minute walk test
Time Frame
week 0, week 6, week 12
Title
3D gait analysis
Time Frame
week 0, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Ammann-Reiffer, MPTSc
Organizational Affiliation
University Children's Hospital Zurich, Rehabilitation Center Affoltern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paediatric Therapy Center Reha Rheinfelden
City
Rheinfelden
State/Province
Aargau
ZIP/Postal Code
CH-4310
Country
Switzerland
Facility Name
University Children's Hospital Zurich, Rehabilitation Centre Affoltern
City
Affoltern am Albis
ZIP/Postal Code
CH-8910
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32444573
Citation
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.
Results Reference
derived
PubMed Identifier
28253887
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
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