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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Device: Application of 3D scanner to measure physical size in patients with severe cerebral palsy

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Severe cerebral palsy (GMFCS IV and V); 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; 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.

What is the study measuring?

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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Juseok Ryu, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Cerebral palsy; Hip dislocation; 3D Scanner; Orthotic devices; Protective devices
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Brain Damage, Chronic; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Joint Dislocations; Cerebral Palsy; Hip Dislocation; Paralysis
• Other Study ID Numbers: E-2201-732-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No