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NCT Number: NCT05388422

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

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.

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Nervous System Diseases Wounds and Injuries

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Migration index

    Time frame: 1 weeks

    Hip AP radiography

Secondary outcomes

  1. Visual analog scale (Pain index)

    Time frame: 1 weeks

    measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.

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

    Time frame: 1 weeks

    measure the quality of life expressed by score from 0 to 100. The higher the quality of life.

  3. Likert scale (score)

    Time frame: 1 weeks

    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.

  4. Range of motion of hip joint

    Time frame: 1 weeks

    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.

  5. wearability test

    Time frame: 1 weeks

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 24, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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