- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05831904
Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People
June 19, 2023 updated by: Ju Seok Ryu, Seoul National University Hospital
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ju Seok Ryu, M.D. PhD
- Phone Number: +82-31-787-7739
- Email: jseok337@snu.ac.kr
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Recruiting
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
-
Contact:
- Juseok Ryu, M.D, PhD
- Phone Number: +82-31-787-7739
- Email: jseok337@snu.ac.kr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 20 healthy children
20 healthy children aged 5 to 15 years , without any congenital or developmental abnormalities of their hip joint
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle activation values on surface electromyography(sEMG)
Time Frame: 10 seconds for each session
|
surface muscle contraction of bilateral hip girdle muscles bilateral gluteus medius, tensor fascia lata, iliopsoas, rectus femoris muscles |
10 seconds for each session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS (Visual Analogue Scale)
Time Frame: 10 seconds for each session
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ju Seok Ryu, M.D. PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Estimated)
May 30, 2024
Study Completion (Estimated)
May 30, 2024
Study Registration Dates
First Submitted
April 16, 2023
First Submitted That Met QC Criteria
April 16, 2023
First Posted (Actual)
April 26, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 19, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2212-801-305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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