Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy

Not Applicable

Terminated

• Conditions: Cerebral Palsy
• Interventions: Other: Lokomat training

• Registration Number: NCT00887848
• Lead Sponsor: University Children's Hospital, Zurich

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.

Study Timeline

• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Study Start: 2009-10-05
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waiting list	Lokomat training	Lokomat training after waiting phase of 5 weeks
Lokomat training	Lokomat training	Lokomat training

Primary Outcome Measures

Name	Time	Method
GMFM-66, section E	week 0, week 6, week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Paediatric Therapy Center Reha Rheinfelden; 🇨🇭 Rheinfelden, Aargau, Switzerland

University Children's Hospital Zurich, Rehabilitation Centre Affoltern; 🇨🇭 Affoltern am Albis, Switzerland