Clinical trial NCT02160457: Gait Analysis and Interdisciplinary Interventions for Children With Cerebral Palsy
Official title: Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Instrumented gait analysis
Gait Deviation Index
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Sonderborg Hospital
name: Sygehus Lillebaelt
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: University of Salford
name: Region of Southern Denmark
name: Ludvig and Sara Elsass Foundation
name: Association of Danish Physiotherapists
First posted: 2014-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Gait Deviation Index
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Change from baseline in 1-minute walk test
timeFrame: Baseline, 52 weeks
measure: Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
timeFrame: Baseline, 52 weeks
measure: Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
timeFrame: Baseline, 52 weeks
measure: Change from baseline in Pediatric Outcome Data Collection Instrument
timeFrame: Baseline, 52 weeks
measure: Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory
timeFrame: Baseline, 26 weeks
measure: Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module
timeFrame: Baseline, 26 weeks
measure: Change from baseline in Pediatric Outcome Data Collection Instrument
timeFrame: Baseline, 26 weeks
Other outcomes:
measure: Change from baseline in Gait Variable Score
timeFrame: Baseline, 52 weeks
measure: Change from baseline in Measure of Processes of Care
timeFrame: Baseline, 52 weeks
measure: Applied interventions
timeFrame: 52 weeks
measure: Difference in recommended and applied interventions
timeFrame: Baseline, 52 weeks
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark - Odense University Hospital
Study officials:
affiliation: University of Southern Denmark and Odense University Hospital
name: Helle Rasmussen, Ph.d. stud.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark and Odense University Hospital
name: Anders Holsgaard-Larsen, Ph.d.
role: STUDY_CHAIR
References:
citation: Fonvig CE, Rasmussen HM, Overgaard S, Holsgaard-Larsen A. Effectiveness of instrumented gait analysis in interdisciplinary interventions on parents' perception of family-centered service and on gross motor function in children with cerebral palsy: a randomized controlled trial. BMC Pediatr. 2020 Sep 1;20(1):411. doi: 10.1186/s12887-020-02315-2.
citation: Rasmussen HM, Pedersen NW, Overgaard S, Hansen LK, Dunkhase-Heinl U, Petkov Y, Engell V, Baker R, Holsgaard-Larsen A. The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol. BMC Pediatr. 2015 Dec 7;15:202. doi: 10.1186/s12887-015-0520-7.