Back to resultsComparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery
Primary Purpose
Muscle Disorder, Postoperative Pain, Shoulder Injuries
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
whole body tilt device (Spine Balance 3D)
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Disorder
Eligibility Criteria
Inclusion Criteria:
- arthroscopic shoulder surgery
- limit of motion due to shoulder pain
Exclusion Criteria:
- 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
Sites / Locations
- Sahmyook University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arthroscopic shoulder surgery patients
Arm Description
Outcomes
Primary Outcome Measures
direction core muscle ratio (DCMR)
DCMR was calculated as a percentage of time located in each direction.
core muscle state ratio (CMSR)
CMSR was calculated as a percentage of the value compared to the reference data of healthy adults.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04625816
Brief Title
Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery
Official Title
Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery: A STROBE-compliant Cross-sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
December 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Disorder, Postoperative Pain, Shoulder Injuries, Immobilization, Asymmetric Limb Muscle Stiffness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic shoulder surgery patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
whole body tilt device (Spine Balance 3D)
Intervention Description
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.
Primary Outcome Measure Information:
Title
direction core muscle ratio (DCMR)
Description
DCMR was calculated as a percentage of time located in each direction.
Time Frame
1 Day
Title
core muscle state ratio (CMSR)
Description
CMSR was calculated as a percentage of the value compared to the reference data of healthy adults.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
arthroscopic shoulder surgery
limit of motion due to shoulder pain
Exclusion Criteria:
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
Facility Information:
Facility Name
Sahmyook University
City
Seoul
ZIP/Postal Code
01795
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
I plan to decide after the study is over.
Learn more about this trial
Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery
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