Application of 3D Scanner to Measure Physical Size in Patients With Severe Cerebral Palsy

Study Overview
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Brief Summary
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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
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Design : Prospective Study Setting: Hospital rehabilitation department and Home 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. 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.

Official Title
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Physical Measurement in Patients With Severe Cerebral Palsy Using 3D Scanner and Improvement of Manufacturing Techniques for Hip Dislocation Prevention Assistive Devices

Conditions
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Cerebral Palsy, Spastic

Intervention / Treatment
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* Device: Application of 3D scanner to measure physical size in patients with severe cerebral palsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of cerebral palsy age 1-15 years GMFCS Level IV, V quadriplegia, or diplegia for more than 6 months Patients who have written consent with permission from the child and caregiver. Exclusion Criteria: Patients who did not agree to participate in the study Patients who refused the examination Patients who had hip surgery experience Patients who were scheduled to undergo surgery during the clinical study Patients who could not be measured with a 3D scanner

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe cerebral palsy (GMFCS IV and V)<br>This study included patients with severe cerebral palsy (GMFCS IV and V) | Device: Application of 3D scanner to measure physical size in patients with severe cerebral palsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration index | Hip AP radiography | 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (Pain index) | measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain. | 1 weeks | 
| Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) | measure the quality of life expressed by score from 0 to 100. The higher the quality of life. | 1 weeks | 
| Likert scale (score) | 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. | 1 weeks | 
| Range of motion of hip joint | 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. | 1 weeks | 
| wearability test | 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. | 1 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Scanner, Cerebral palsy, Hip dislocation, Orthotic devices, Protective devices