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

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic
• Interventions: Device: Application of 3D scanner to measure physical size in patients with severe cerebral palsy

• Registration Number: NCT05388422
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-06-02
• Primary Completion: 2023-01-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe cerebral palsy (GMFCS IV and V)	Application of 3D scanner to measure physical size in patients with severe cerebral palsy	This study included patients with severe cerebral palsy (GMFCS IV and V)

Primary Outcome Measures

Name	Time	Method
Migration index	1 weeks	Hip AP radiography

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of