Study Stopped
Recruitment problems
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy
PeLoGAIT
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedStudy Start
First participant enrolled
October 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2017
CompletedMarch 30, 2018
March 1, 2018
7.9 years
April 23, 2009
March 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GMFM-66, section E
week 0, week 6, week 12
Secondary Outcomes (4)
GMFM-66, section D
week 0, week 6, week 12
Gait speed
week 0, week 6, week 12
6-minute walk test
week 0, week 6, week 12
3D gait analysis
week 0, week 6
Study Arms (2)
Lokomat training
EXPERIMENTALLokomat training
Waiting list
OTHERLokomat training after waiting phase of 5 weeks
Interventions
15 sessions of Lokomat training within 5 weeks (3 trainings/week)
Eligibility Criteria
You may qualify if:
- Bilateral spastic cerebral palsy
- Gross Motor Function Classification Scale (GMFCS) II-IV
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Children's Hospital, Zurichlead
- Reha Rheinfeldencollaborator
Study Sites (2)
Paediatric Therapy Center Reha Rheinfelden
Rheinfelden, Canton of Aargau, CH-4310, Switzerland
University Children's Hospital Zurich, Rehabilitation Centre Affoltern
Affoltern am Albis, CH-8910, Switzerland
Related Publications (2)
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.
PMID: 32444573DERIVEDAmmann-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.
PMID: 28253887DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corinne Ammann-Reiffer, MPTSc
University Children's Hospital Zurich, Rehabilitation Center Affoltern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
October 5, 2009
Primary Completion
August 14, 2017
Study Completion
August 14, 2017
Last Updated
March 30, 2018
Record last verified: 2018-03