NCT04625816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

November 28, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

14 days

First QC Date

November 1, 2020

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Arthroscopic shoulder surgery patients

EXPERIMENTAL
Device: whole body tilt device (Spine Balance 3D)

Interventions

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.

Arthroscopic shoulder surgery patients

Eligibility Criteria

Age26 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arthroscopic shoulder surgery
  • limit of motion due to shoulder pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahmyook University

Seoul, 01795, South Korea

Location

MeSH Terms

Conditions

Muscular DiseasesPain, PostoperativeShoulder Injuries

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 12, 2020

Study Start

November 28, 2020

Primary Completion

December 12, 2020

Study Completion

December 19, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations