Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— PeLoGAIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00887848
• Other study ID #: PeLoGAIT_2009
• Status: Terminated
• Phase: N/A
• First received: April 23, 2009
• Last updated: March 28, 2018
• Start date: October 5, 2009
• Est. completion date: August 14, 2017

Study information

• Verified date: March 2018
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Lokomat training
15 sessions of Lokomat training within 5 weeks (3 trainings/week)

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich, Rehabilitation Centre Affoltern	Affoltern am Albis
Switzerland	Paediatric Therapy Center Reha Rheinfelden	Rheinfelden	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	Reha Rheinfelden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMFM-66, section E		week 0, week 6, week 12
Secondary	GMFM-66, section D		week 0, week 6, week 12
Secondary	Gait speed		week 0, week 6, week 12
Secondary	6-minute walk test		week 0, week 6, week 12
Secondary	3D gait analysis		week 0, week 6

External Links

•   Homepage of the rehabilitation centre Affoltern am Albis, University Children's Hospital Zurich
•   Research projects at the rehabilitation centre Affoltern am Albis, University Children's Hospital Zurich