NCT05831904

Brief Summary

This clinical trial(prospective, pilot study) is to learn about the effect of whole-body vibration on hip girdle muscles in healthy children as a primary study aiming for a new clinical intervention protocol to prevent hip dislocation in patients with severe cerebral palsy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

April 16, 2023

Last Update Submit

June 19, 2023

Conditions

Hip Dislocation

Outcome Measures

Primary Outcomes (1)

  • muscle activation values on surface electromyography(sEMG)

    surface muscle contraction of bilateral hip girdle muscles bilateral gluteus medius, tensor fascia lata, iliopsoas, rectus femoris muscles

    10 seconds for each session

Secondary Outcomes (1)

  • VAS (Visual Analogue Scale)

    10 seconds for each session

Study Arms (1)

20 healthy children

EXPERIMENTAL

20 healthy children aged 5 to 15 years , without any congenital or developmental abnormalities of their hip joint

Device: whole-body vibration

Interventions

whole-body vibrationDEVICE

After attaching the surface electromyography(EMG) to bilateral hip girdle muscles, participants will walk and jump at their comfortable speed. After investigator record the muscle activation values, participants will be asked to stand on the vibration device. While the whole-body vibration is applied, the hip girdle muscles activation values will be recorded accordingly via sEMG.

20 healthy children

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children (5 to 15 years old)

You may not qualify if:

  • Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities
  • Children who underwent hip joint surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Officials

  • Ju Seok Ryu, M.D. PhD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Central Study Contacts

Ju Seok Ryu, M.D. PhD

CONTACT

+82-31-787-7739jseok337@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 26, 2023

Study Start

June 1, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

KR(1)