NCT02160457

Gait Analysis and Interdisciplinary Interventions for Children With Cerebral Palsy

Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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'.

Detailed 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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	Intervention with IGA	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: 1. Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000) 2. Impairment-Focused Interpretation 3. Recommendation for interdisciplinary interventions 4. 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.

Timeline

• Start date: 2014-08-06
• Primary completion: 2017-07-05
• Completion: 2017-07-05
• First posted: 2014-06-10
• Last updated: 2018-04-06

Locations

1 site across 1 country: Denmark