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Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People

Primary Purpose

Hip Dislocation

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

whole-body vibration

About this trial

This is an interventional prevention trial for Hip Dislocation

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

20 healthy children

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05831904

First Posted

April 16, 2023

Last Updated

June 19, 2023

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05831904

Brief Title

Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People

Official Title

Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Dislocation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

20 healthy children

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

whole-body vibration

Intervention Description

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.

Primary Outcome Measure Information:

Title

muscle activation values on surface electromyography(sEMG)

Description

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

Time Frame

10 seconds for each session

Secondary Outcome Measure Information:

Title

VAS (Visual Analogue Scale)

Description

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

Time Frame

10 seconds for each session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ju Seok Ryu, M.D. PhD

Phone

+82-31-787-7739

jseok337@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ju Seok Ryu, M.D. PhD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juseok Ryu, M.D, PhD

Phone

+82-31-787-7739

jseok337@snu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People

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