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Completed

NCT Number: NCT04483050

The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study

The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age from 1 to 15
  • Patients with severe neuromuscular disease
  • Patients who agreed to participate in the study
  • Hip dislocation more than 10% (migration index)

Exclusion criteria

  • If do not agree with the study
  • Those who are determined to be difficult to participate under the judgment of the research director
  • History of hip joint surgery

Treatment and study plan

Hip protection orthosis

Device

Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.

Primary outcomes

  1. Migration index

    Time frame: 6 months

    Hip AP radiography

Secondary outcomes

  1. Cobb's angle (')

    Time frame: 6 months

    using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.

  2. Range of motion of hip joint (')

    Time frame: 6 months

    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.

  3. Visual analog scale

    Time frame: 6 months

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

  4. Likert scale (score)

    Time frame: immediately after wearing orthosis

    measure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.

  5. Child Health Index of Life with Disabilities (CPCHILD)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2020
Registry last updated
Nov 25, 2022

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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