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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05831904
Other study ID # B-2212-801-305
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date May 30, 2024

Study information

Verified date June 2023
Source Seoul National University Hospital
Contact Ju Seok Ryu, M.D. PhD
Phone +82-31-787-7739
Email jseok337@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Design: Prospective, pilot study Setting: hospital rehabilitation department Intervention: Participants will be asked to walk and jump with a surface electromyography(EMG) attached to their hip girdle muscles. After the participants are positioned(standing) on the platform of whole-body vibration device, the study practitioner will record the sEMG values from the hip girdle muscles during the vibration applied. The mean values of repeating the same process with different vibrations applications and the values before vibration will be compared by using the SPSS using the paired "t-test" or Wilcoxon signed rank test for comparison between before and after vibration in the same group.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria: - Healthy children (5 to 15 years old) Exclusion Criteria: - Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities - Children who underwent hip joint surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
whole-body vibration
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.

Locations

Country Name City State
Korea, Republic of Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 VAS (Visual Analogue Scale) a psychometric scale that is generally used in pain scale surveys and this study participants will be asked to scale the uncomfortable feelings during the vibration 10 seconds for each session
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