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

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Application of 3D scanner to measure physical size in patients with severe cerebral palsy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy, Spastic focused on measuring 3D Scanner, Cerebral palsy, Hip dislocation, Orthotic devices, Protective devices

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between 1 and 14 years of age
  • Children with Severe Cerebral Palsy (GMFCS IV and V)
  • Patients who agreed to participate in the study

Exclusion Criteria:

  • Patients who disagree with the study
  • Patients who are deemed difficult to participate at the discretion of the research director
  • Patients with hip surgery or who are scheduled to perform surgery during clinical studies

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Severe cerebral palsy (GMFCS IV and V)

Arm Description

This study included patients with severe cerebral palsy (GMFCS IV and V)

Outcomes

Primary Outcome Measures

Migration index
Hip AP radiography

Secondary Outcome Measures

Visual analog scale (Pain index)
measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
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.
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.
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.
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.

Full Information

First Posted
May 12, 2022
Last Updated
April 27, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05388422
Brief Title
Application of 3D Scanner to Measure Physical Size in Patients With Severe Cerebral Palsy
Official Title
Physical Measurement in Patients With Severe Cerebral Palsy Using 3D Scanner and Improvement of Manufacturing Techniques for Hip Dislocation Prevention Assistive Devices
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Design : Prospective Study Setting: Hospital rehabilitation department and Home 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
3D Scanner, Cerebral palsy, Hip dislocation, Orthotic devices, Protective devices

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Severe cerebral palsy (GMFCS IV and V)
Arm Type
Experimental
Arm Description
This study included patients with severe cerebral palsy (GMFCS IV and V)
Intervention Type
Device
Intervention Name(s)
Application of 3D scanner to measure physical size in patients with severe cerebral palsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Migration index
Description
Hip AP radiography
Time Frame
1 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale (Pain index)
Description
measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Time Frame
1 weeks
Title
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
Description
measure the quality of life expressed by score from 0 to 100. The higher the quality of life.
Time Frame
1 weeks
Title
Likert scale (score)
Description
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
Title
Range of motion of hip joint
Description
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
Title
wearability test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juseok Ryu
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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