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

Seoul National University Hospital19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cerebral Palsy, Spastic

Interventions

Application of 3D scanner to measure physical size in patients with severe cerebral palsyDEVICE

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Migration index

Hip AP radiography

Time frame: 1 weeks

Secondary Outcomes

Visual analog scale (Pain index)

measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 weeks

Data from ClinicalTrials.gov

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