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

Cerebral Palsy, Spastic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05388422
• Other study ID #: E-2201-732-001
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Hip Dislocation
• Paralysis

Intervention

Device:
• Application 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration index	Hip AP radiography	1 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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