NCT04426929

Brief Summary

Rotator Cuff muscles are injured due to frequent use, repeated subacromial loadings and circulatory failure, traction, compression, contusion, subacromial abrasion, inflammation, injection and age-related degeneration, causing Rotator Cuff ruptures.Rotator Cuff treatment strategies vary according to the stage of the disease. While conservative treatment is preferred in Stage 1 and Stage 2 of Rotator Cuff injuries, surgical approaches are performed in stage 3. The most common conservative methods used in its treatment are corticosteroid injections, nonsteroidal anti-inflammatory drugs and physiotherapy methods. When the literature is examined, there is no consensus about physiotherapy methods among conservative treatment approaches. It is stated in the literature that there is no standard exercise protocol for Rotator Cuff rehabilitation and specific exercise programs are needed. In addition, the virtual reality treatment approach, the most common example of the use of technology in rehabilitation, has begun to take part in rehabilitation studies. The aim of the project is to examine the effectiveness of video-based game exercise therapy in individuals with Rotator Cuff rupture, to develop a new exercise protocol with closed kinetic chain exercises and to investigate the most effective treatment method for Rotator Cuff ruptures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

June 9, 2020

Last Update Submit

October 14, 2021

Conditions

Keywords

Virtual RealityExerciseRotator Cuff Injury

Outcome Measures

Primary Outcomes (4)

  • VAS

    The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    5 minutes

  • pain threshold

    with algometer

    5 minutes

  • Normal range of motion and proprioception

    Normal range of motion and proprioception can be measured with Fizyosoft applications.

    10 minutes

  • Shoulder aproximation force

    Shoulder aproximation force will be evaluated Fizyosoft balance system. The patient's shoulder should be 0 and 90 degree of flexion position. And then they give their force on the platform of the Fizyosoft system.

    10 minutes

Secondary Outcomes (2)

  • Functionality

    5 minutes

  • Rotator Cuff Quality of life Scale

    10 minutes

Study Arms (3)

Conventional Group

EXPERIMENTAL

Electrotherapy program will be applied to all individuals. conventional exercise therapy will be applied to this group.

Other: Conventional exercise therapy

Closed Chain Exercise Group

EXPERIMENTAL

An exercise program consisting of 3 phases that runs from simple to difficult and includes closed kinetic chain exercises and proprioceptive exercises will be implemented in this group.

Other: Closed Chain Exercise Group

Video Based Exercise Group

EXPERIMENTAL

Video based exercise program will be applied to the this group.

Other: Video Based Exercise Group

Interventions

Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.

Conventional Group

An exercise program consisting of 3 phases that runs from simple to difficult and includes closed kinetic chain exercises and proprioceptive exercises will be implemented in this group.

Closed Chain Exercise Group

Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.

Video Based Exercise Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who have been diagnosed with Rotator Cuff partial rupture between the ages of 18-60, who do not have a professional sports history, who have had pain for more than 4 weeks, and have not undergone any shoulder surgery will be included

You may not qualify if:

  • Individuals with symptomatic neurological findings of cervical origin, having an additional orthopedic problem on the shoulder, having mental problems, and individuals with neurological, vascular, cardiac problems that limit function will not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

Related Publications (1)

  • Pekyavas NO, Ergun N. Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect. Acta Orthop Traumatol Turc. 2017 May;51(3):238-242. doi: 10.1016/j.aott.2017.03.008. Epub 2017 Apr 24.

MeSH Terms

Conditions

Rotator Cuff InjuriesMotor Activity

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesBehavior

Study Design

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

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 11, 2020

Study Start

June 15, 2020

Primary Completion

August 18, 2021

Study Completion

October 12, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

I will publish my manuscript about this study, so researchers can access my individual participant data with this way.

Locations