Cerebral Palsy, Spastic
Conditions
Keywords
3D Scanner, Cerebral palsy, Hip dislocation, Orthotic devices, Protective devices
Brief summary
The aim of this study is to improve the manufacturing techniques of hip brace in preventing progressive hip displacement in patients with severe cerebral palsy, through the measurement of patient's physical size using a 3D scanner.
Detailed description
1. Design : Prospective Study 2. Setting: Hospital rehabilitation department and Home 3. Intervention: Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed. 4. Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes: the hip and knee joint range of motion (ROM), pain intensity, satisfaction and discomfort score for the hip brace, quality of life (QOL) of the patients and their caregivers, and the wearability test.
Interventions
DEVICEApplication of 3D scanner to measure physical size in patients with severe cerebral palsy
Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. diagnosis of cerebral palsy 2. age 1-15 years 3. GMFCS Level IV, V 4. quadriplegia, or diplegia for more than 6 months 5. Patients who have written consent with permission from the child and caregiver.
Exclusion criteria
1. Patients who did not agree to participate in the study 2. Patients who refused the examination 3. Patients who had hip surgery experience 4. Patients who were scheduled to undergo surgery during the clinical study 5. Patients who could not be measured with a 3D scanner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration index | 1 weeks | Hip AP radiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (Pain index) | 1 weeks | measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain. |
| Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) | 1 weeks | measure the quality of life expressed by score from 0 to 100. The higher the quality of life. |
| Likert scale (score) | 1 weeks | measure the satisfaction, and discomfort about hip protection orthosis expressed by score from 1 to 5. The closer to 1, the higher the satisfaction or comfort. |
| Range of motion of hip joint | 1 weeks | Using goniometer, measure the hip and knee abduction and flexion angle expressed by degree from 0' to 180'. The closer to 180', the better the value. |
| wearability test | 1 weeks | the Wearability Test consisted of four questions on wearing sensation, five questions about on fit, and four questions on motion suitability evaluation. Each item was scored on 5-point scale, with a total score of 65. |
Countries
South Korea
Outcome results
None listed