Hip DislocationNCT05831904
Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People
A study testing whole-body vibration in people with Hip Dislocation, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Dislocation
- What is being tested?
- whole-body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children (5 to 15 years old)
Who cannot join
- Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities
- Children who underwent hip joint surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Seongnam-si, Gyeonggi-do, 463-707
Juseok Ryu, M.D, PhD, +82-31-787-7739, jseok337@snu.ac.kr
About this study
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.
Read the 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.
- Conditions
- Hip Dislocation
- Being tested
- whole-body vibration
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 healthy children | Experimental | 20 healthy children aged 5 to 15 years , without any congenital or developmental abnormalities of their hip joint Receives: Device: whole-body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 seconds for each session
Secondary outcomes (1)
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
Measured: 10 seconds for each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jun 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DislocationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
- Investigators
- Ju Seok Ryu, M.D. PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831904
- Sponsor's protocol ID
- B-2212-801-305
- Status last verified
- Jun 2023
- First submitted
- 16 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People
- ClinicalTrials.gov ID
- NCT05831904
- Acronym / sponsor ID
- B-2212-801-305
- Conditions
- Hip Dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 healthy children | Experimental | Device: whole-body vibration20 healthy children aged 5 to 15 years , without any congenital or developmental abnormalities of their hip joint |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children (5 to 15 years old)
Key exclusion criteria (2 listed)
- Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities
- Children who underwent hip joint surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole-body vibrationAfter 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. | Device | 20 healthy children |
Primary outcome
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
1 secondary outcome
VAS (Visual Analogue Scale)
Time frame: 10 seconds for each session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Seok Ryu, M.D. PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole-body vibration in people with Hip Dislocation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Seok Ryu, M.D. PhD (+82-31-787-7739, jseok337@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle activation values on surface electromyography(sEMG) (time frame: 10 seconds for each session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.