Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Shoulder Injuries; Immobilization; Muscle Disorder; Asymmetric Limb Muscle Stiffness
• Intervention / Treatment: Device: whole body tilt device (Spine Balance 3D)

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 01795
    • Sahmyook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arthroscopic shoulder surgery patients	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
direction core muscle ratio (DCMR)	DCMR was calculated as a percentage of time located in each direction.	1 Day
core muscle state ratio (CMSR)	CMSR was calculated as a percentage of the value compared to the reference data of healthy adults.	1 Day

Collaborators and Investigators

• Sponsor: Sahmyook University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2020
• Primary Completion (Actual): December 12, 2020
• Study Completion (Actual): December 19, 2020

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Musculoskeletal Diseases; Neuromuscular Diseases; Shoulder Injuries; Muscular Diseases
• Other Study ID Numbers: 2020117HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I plan to decide after the study is over.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No