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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, Open Label, Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04483050
Enrollment
4
Registered
2020-07-23
Start date
2020-02-05
Completion date
2021-03-11
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Brief summary

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

Interventions

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

Sponsors

Korea Health Industry Development Institute
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Migration index6 monthsHip AP radiography

Secondary

MeasureTime frameDescription
Visual analog scale6 monthsmeasure the pain expressed by score from 0 to 10. The closer to 10, the higher the pain.
Cobb's angle (')6 monthsusing radiography, expressed by degree from 0' to 180'. The closer to 0', the better the value.
Range of motion of hip joint (')6 monthsUsing 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.
Likert scale (score)immediately after wearing orthosismeasure the satisfaction about hip protection orthosis expressed by score from 0 to 5. The closer to 5, the higher the satisfaction.
Child Health Index of Life with Disabilities (CPCHILD)6 monthsmeasure the quality of life expressed by score from 0 to 100. The higher the quality of life.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026