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

NCT05388422 | Completed

• 1 other identifier: E-2201-732-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

3D Scanner; Cerebral palsy; Hip dislocation; Orthotic devices; Protective devices

Outcome Measures

Primary Outcomes (1)

• Migration index

  Hip AP radiography

  1 weeks

Secondary Outcomes (5)

• Visual analog scale (Pain index)

  1 weeks

• Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)

  1 weeks

• Likert scale (score)

  1 weeks

• Range of motion of hip joint

  1 weeks

• wearability test

  1 weeks

Study Arms (1)

Severe cerebral palsy (GMFCS IV and V)

EXPERIMENTAL

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

Interventions

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

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.

Severe cerebral palsy (GMFCS IV and V)

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

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

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• Kim JM, Lim J, Choi SY, Rhim SH, Beom J, Ryu JS. Application of 3D scanner to measure physical size and improvement of hip brace manufacturing technology in severe cerebral palsy patients. Sci Rep. 2023 Nov 24;13(1):20691. doi: 10.1038/s41598-023-47665-w.

  PMID: 38001232 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Juseok Ryu

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: June 2, 2022
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

KR (1)