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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: Hip protection orthosis

• Registration Number: NCT04483050
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Primary Completion: 2021-03-11
• Study Completion: 2021-03-11
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Hip protection orthosis	-

Primary Outcome Measures

Name	Time	Method
Migration index	6 months	Hip AP radiography

Secondary Outcome Measures

Name	Time	Method
Likert scale (score)	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.
Cobb's angle (')	6 months	using radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.
Visual analog scale	6 months	measure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Child Health Index of Life with Disabilities (CPCHILD)	6 months	measure the quality of life expressed by score from 0 to 100. The higher the quality of life.
Range of motion of hip joint (')	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Seongnam-si, Gyeonggi-do, Korea, Republic of