Muscle DisorderNCT04625816
Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery
A study testing whole body tilt device (Spine Balance 3D) in people with Muscle Disorder and Postoperative Pain, run by Sahmyook University at 1 site in South Korea.
Trial summary
This study is an observational cross-sectional study. Post-operative patients need an immobilization period for a certain period of time after surgery. Kinetic chain changes due to immobilization can affect the symmetry of the core muscle. Read more about this study
- Who is it for?
- Ages 26 to 66 years
- Conditions the study is for
- Muscle Disorder, Postoperative Pain, Shoulder Injuries
- What is being tested?
- whole body tilt device (Spine Balance 3D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Nov 2020to 19 Dec 2020
- 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 26 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arthroscopic shoulder surgery
- limit of motion due to shoulder pain
Who cannot join
- orthopedic surgery or other medical history in the lower extremities
- neurological history or are taking related medications
- chronic headache or disease related to the inner ear
- cardiovascular disease that may affect balance ability or take related medications
- acute dizziness
- when performing other balance training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery: A STROBE-compliant Cross-sectional Study
This study is an observational cross-sectional study. Post-operative patients need an immobilization period for a certain period of time after surgery. Kinetic chain changes due to immobilization can affect the symmetry of the core muscle. Therefore, in this study, core muscle asymmetry (CMA) is measured using a whole body tilt device for inpatients who have undergone arthroscopic shoulder surgery. We would like to make a clinical suggestion for post-operative rehabilitation by identifying the characteristics of CMA according to the left or right site.
- Conditions
- Muscle Disorder, Postoperative Pain, Shoulder Injuries, Immobilization, Asymmetric Limb Muscle Stiffness
- Being tested
- whole body tilt device (Spine Balance 3D)
- Medical subject headings
- Muscular Diseases, Pain, Postoperative, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body tilt device (Spine Balance 3D)Device
The symmetry of the deep muscle was evaluated using a whole body tilt device (Spine Balance 3D, Cyber Medic Co., Ltd., Korea). Spine Balance 3D can evaluate the maintenance strength and maximum strength of the core muscles, and perform a personalized core muscle training program based on the evaluated results.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic shoulder surgery patients | Experimental | Not described Receives: Device: whole body tilt device (Spine Balance 3D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
direction core muscle ratio (DCMR)
DCMR was calculated as a percentage of time located in each direction.
Measured: 1 Day
core muscle state ratio (CMSR)
CMSR was calculated as a percentage of the value compared to the reference data of healthy adults.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start28 Nov 2020
- Primary completion12 Dec 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625816
- Sponsor's protocol ID
- 2020117HR
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I plan to decide after the study is over.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery: A STROBE-compliant Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04625816
- Acronym / sponsor ID
- 2020117HR
- Conditions
- Muscle Disorder, Postoperative Pain, Shoulder Injuries, Immobilization, Asymmetric Limb Muscle Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 28 Nov 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 12 Nov 2020 (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 study is an observational cross-sectional study. Post-operative patients need an immobilization period for a certain period of time after surgery. Kinetic chain changes due to immobilization can affect the symmetry of the core muscle. Therefore, in this study, core muscle asymmetry (CMA) is measured using a whole body tilt device for inpatients who have undergone arthroscopic shoulder surgery. We would like to make a clinical suggestion for post-operative rehabilitation by identifying the characteristics of CMA according to the left or right site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic shoulder surgery patients | Experimental | Device: whole body tilt device (Spine Balance 3D) |
Who may qualify
- Ages
- 26 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- arthroscopic shoulder surgery
- limit of motion due to shoulder pain
Key exclusion criteria (6 listed)
- orthopedic surgery or other medical history in the lower extremities
- neurological history or are taking related medications
- chronic headache or disease related to the inner ear
- cardiovascular disease that may affect balance ability or take related medications
- acute dizziness
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 tilt device (Spine Balance 3D)The symmetry of the deep muscle was evaluated using a whole body tilt device (Spine Balance 3D, Cyber Medic Co., Ltd., Korea). Spine Balance 3D can evaluate the maintenance strength and maximum strength of the core muscles, and perform a personalized core muscle training program based on the evaluated results. | Device | Arthroscopic shoulder surgery patients |
Primary outcome
direction core muscle ratio (DCMR)
Time frame: 1 Day
DCMR was calculated as a percentage of time located in each direction.
core muscle state ratio (CMSR)
Time frame: 1 Day
CMSR was calculated as a percentage of the value compared to the reference data of healthy adults.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Undecided. I plan to decide after the study is over.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 tilt device (Spine Balance 3D) in people with Muscle Disorder and Postoperative Pain, run by Sahmyook University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
direction core muscle ratio (DCMR) (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 13 Jan 2021.