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

NCT ID: NCT05388422

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy, Spastic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe cerebral palsy (GMFCS IV and V)

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ju Seok Ryu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juseok Ryu

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38001232 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-2201-732-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.