NCT05184309

Brief Summary

The aim of this study is to examine the effect of Serious-Game Exercise (SGE) platform on pain, range of motion (ROM), joint position sense, shoulder functions, and approximation force in patients with rotator cuff rupture. In addition, another objective is to evaluate the usage of balance board as a measurement tool for measuring the approximation force in the rotator cuff rupture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

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

December 26, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

22 days

First QC Date

December 26, 2021

Last Update Submit

March 3, 2022

Conditions

Keywords

Serious gameRotator cuff ruptureShoulder Rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Pain assessment- Visual Analogue scale

    Pain level is measured with the visual analogue scale (VAS), at rest and activity. The visual analogue scale consists of a 10-cm line. Participants were asked to indicate in the scale their current level of pain where the higher values are more intense pain.

    5 minutes

  • Range of motion

    The range of motion of the joint of the individuals participating in the study will be evaluated with Becure Extremity ROM. The patient stands in front of the camera and perform the directed movement. In this study, flexion, abduction and external rotation ranges of motion of the shoulder joint will be measured.

    5 minutes

  • Joint position sense

    The joint position sense of the individuals will be evaluated with the Becure Extremity ROM. Subjects will be first asked to raise their shoulder to a certain degree and bring it to the same angle value with eyes closed. The difference between shoulder angles will be calculated by recording the angle value formed with eyes closed and open.

    5 minutes

  • Shoulder approximation force

    Shoulder approximation force will be evaluated with the Becure Balance System. During this measurement, the individual will be asked to put both hands on the Balance Board and then apply downward force without using body weight. Measurements will be taken in standing and sitting positions (0° and 90°).

    5 minutes

Secondary Outcomes (1)

  • The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

    5 minutes

Study Arms (2)

Conventional exercise group

EXPERIMENTAL

Conventional Exercises

Other: ConventioanalExercises

Serious game group

EXPERIMENTAL

Serious Games

Other: Serious games

Interventions

Wand exercises and shoulder wheel exercises to increase the range of motion of the shoulder joint with 10 repetitions will be applied in CEG. Finger ladder exercises will be performed in the abduction and flexion position with 5 repetitions, holding the endpoint for 5 seconds. Stretching exercises with 5 repetitions will be applied in all directions for the limitation of movement, holding it for 20 seconds at the endpoint. Individuals performed conventional exercises twice a week for 6 weeks.

Conventional exercise group

A Serious game program will be applied to the individuals twice a week for 6 weeks in this group. Armrotate, Uball, Balance Surf and Balance Adventure games will be developed by Becure company for shoulder rehabilitation. These games developed for shoulder rehabilitation will be applied to individuals under the supervision of a physiotherapist. Each game will be played for 10 minutes, for a total of 40 minutes.

Serious game group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • being between the ages of 40-60,
  • having pain for more than 4 weeks,
  • not having had any shoulder surgery

You may not qualify if:

  • Individuals with cervical-origin neurological findings, uncooperative, different orthopedic problems in the same shoulder,
  • neurological, vascular and cardiac problems that limit function

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.

Related Links

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Burak Menek, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded in enrollment and assessment process.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 26, 2021

First Posted

January 11, 2022

Study Start

January 10, 2022

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

When the study will be published in a journal, all of researchers can see the result of the participants of this study.

Available IPD Datasets

Statistical Analysis Plan (Principle investigator)Access

Locations