Cerebral Palsy Clinical Trial
— CPinMotionOfficial title:
Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial
Verified date | April 2018 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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'.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 5, 2017 |
Est. primary completion date | July 5, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Southern Denmark - Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Association of Danish Physiotherapists, Hospital of South West Jutland, Ludvig and Sara Elsass Foundation, Odense University Hospital, Region of Southern Denmark, Sonderborg Hospital, Sygehus Lillebaelt, University of Salford |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in Gait Variable Score | The Gait Variable Score is used to measure changes in gait pattern. Gait Variable Score is an index for a single gait variable. The Gait Variable Scores are determined for the following nine variables: Pelvic tilt, pelvic obliquity, pelvic rotation, hip flexion, hip adduction, hip rotation, knee flexion, dorsiflexion and foot progression | Baseline, 52 weeks | |
Other | Change from baseline in Measure of Processes of Care | Measure of Processes of Care is a self-report measure of parents' perception of the extent to which the health services that their child receives are family-centred. | Baseline, 52 weeks | |
Other | Applied interventions | Records from the Cerebral Palsy Follow-Up Program of the applied interventions will be used to explore differences (used vs. not used) in the use of the following intervention categories in the two groups: Orthopaedic surgery, Spasticity management, Physical Therapy and Orthotics. | 52 weeks | |
Other | Difference in recommended and applied interventions | Records from the Cerebral Palsy Follow-Up Program of the recommended and actually applied interventions in the experimental group will be used to explore the differences (used vs. not used) in the recommended and actually applied interventions in regard to the following categories: Orthopaedic surgery, Spasticity management, Physical Therapy and Orthotics. | Baseline, 52 weeks | |
Primary | Change from baseline in Gait Deviation Index | Gait Deviation Index (GDI) is based upon kinematic data from the Instrumented Gait Analysis, and is an quantitative index that summarises the overall gait pattern into a single score for each patient by comparison with non-pathological gait. A GDI value of 100 represents the absence of gait pathology, and each 10-point decrement below 100 indicates one standard deviation from normal gait kinematics. For the primary outcome measure, the median of five trials for each leg will be used to calculate the average of both legs to provide a single index for each child. | Baseline, 52 weeks | |
Secondary | Change from baseline in 1-minute walk test | Walking performance is assessed with the 1-minute walk test. The test measure the distance in meters, when the child walks as fast as possible. | Baseline, 52 weeks | |
Secondary | Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory | The Mobility Scale of the Pediatric Evaluation of Disability Inventory evaluates the child's functional mobility in everyday activities with regard to functional skills and caregiver assistance. The Paediatric Evaluation of Disability Inventory will be applied as a parental questionnaire, allowing comparison of the child's functional skills over time for each of the two dimensions. | Baseline, 52 weeks | |
Secondary | Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module | The Pediatric Quality of Life Inventory Cerebral Palsy Module is a measure of health-related quality of life, specifically designed for children with CP. The Pediatric Quality of Life Inventory Cerebral Palsy Module is based upon the parents' report and measures physical, emotional, social and school functioning. | Baseline, 52 weeks | |
Secondary | Change from baseline in Pediatric Outcome Data Collection Instrument | The Pediatric Outcome Data Collection Instrument assesses overall health, pain and participation in normal daily activities. | Baseline, 52 weeks | |
Secondary | Change from baseline in Mobility Scale of the Pediatric Evaluation of Disability Inventory | The Mobility Scale of the Pediatric Evaluation of Disability Inventory evaluates the child's functional mobility in everyday activities with regard to functional skills and caregiver assistance. The Paediatric Evaluation of Disability Inventory will be applied as a parental questionnaire, allowing comparison of the child's functional skills over time for each of the two dimensions. | Baseline, 26 weeks | |
Secondary | Change from baseline in Pediatric Quality of Life Inventory Cerebral Palsy Module | The Pediatric Quality of Life Inventory Cerebral Palsy Module is a measure of health-related quality of life, specifically designed for children with CP. The Pediatric Quality of Life Inventory Cerebral Palsy Module is based upon the parents' report and measures physical, emotional, social and school functioning. | Baseline, 26 weeks | |
Secondary | Change from baseline in Pediatric Outcome Data Collection Instrument | The Pediatric Outcome Data Collection Instrument assesses overall health, pain and participation in normal daily activities. | Baseline, 26 weeks |
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