Overview

This trial is active, not recruiting.

Condition cerebral palsy
Treatment intervention with iga
Sponsor University of Southern Denmark
Collaborator Odense University Hospital
Start date May 2014
End date June 2016
Trial size 60 participants
Trial identifier NCT02160457, S-20120162

Summary

The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by instrumented 3-dimensional gait analysis are superior to those used in 'care as usual'.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis (IGA)
intervention with iga Vicon T40 system, Vicon, Oxford, UK
Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis The instrumented gait analysis consists of four steps: Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000) Impairment-Focused Interpretation Recommendation for interdisciplinary interventions Dissemination of recommendations The two modalities differs in the use of IGA, but the study is not indented to document the effect of IGA alone, but to document the difference in the effects of the interdisciplinary interventions, when IGA is implemented to the experimental group.
(No Intervention)
'Care as usual' - Individually tailored interdisciplinary interventions based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations BUT NOT (IGA).

Primary Outcomes

Measure
Change from baseline in Gait Deviation Index
time frame: Baseline, 52 weeks

Secondary Outcomes

Measure
Change from baseline in 1-minute walk test
time frame: Baseline, 52 weeks
Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
time frame: Baseline, 52 weeks
Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
time frame: Baseline, 52 weeks
Change from baseline in Pediatric Outcome Data Collection Instrument
time frame: Baseline, 52 weeks
Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
time frame: Baseline, 26 weeks
Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
time frame: Baseline, 26 weeks
Change from baseline in Pediatric Outcome Data Collection Instrument
time frame: Baseline, 26 weeks

Eligibility Criteria

Male or female participants from 5 years up to 8 years old.

Inclusion Criteria: - Spastic Cerebral palsy - Gross Motor Function Classification System levels I or II. Exclusion Criteria: - Earlier interventions in the form of orthopaedic surgery within the past 52 weeks, injection with botulinum toxin type A in the 12 weeks prior to baseline assessments - Relocation to another region during the trial. - If the child not are able to demonstrate sufficient co-operation and cognitive understanding to participate in the IGA.

Additional Information

Official title Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial
Principal investigator Helle Rasmussen, Ph.d. stud.
Description Children with cerebral palsy (CP) who walk independently often have an altered gait pattern. Interdisciplinary interventions in terms of orthopaedic surgery, spasticity management, physical therapy and orthotics aim to improve the gait pattern. Standardised measurements are used in the Cerebral Palsy follow-Up Program to assess walking. However, these measurements do not describe features in the gait pattern reflecting underlying neuro-musculoskeletal impairments. This can be done with instrumented 3-dimensional gait analysis (IGA). It has never been investigated whether interdisciplinary interventions designed to address impairments identified by IGA result in improved gait pattern compared with 'care as usual' without IGA in children with CP. The aim of this study is to test the hypothesis, that improvements in gait pattern following individually tailored interventions guided by IGA are superior to those used in 'care as usual'. A prospective, single blind, randomised, parallel group study will be conducted. Participants will be recruited from the Cerebral Palsy follow-Up Program. Children aged 5 to 9 years with spastic CP, classified at Gross Motor Function Classification System levels I or II will be included. The interventions under investigation are 1) Individually tailored interdisciplinary intervention addressing impairments identified by IGA and 2) 'care as usual' (interdisciplinary interventions without IGA). The primary outcome is gait pattern measured by the Gait Deviation Index. Secondary outcome measures are, walking performance and patient-reported outcomes of functional mobility, health-related quality of life and overall health, pain and participation. Explorative outcome measures include walking performance, gait pattern, behavior of health care providers and the applied interventions. The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks after start of intervention; however, exclusively for the patient-reported outcomes. To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention designed to address impairments identified by IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA in interdisciplinary interventions.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Southern Denmark.