Effects of Serious Games for Shoulder Rehabilitation

Effects of Serious Games for Shoulder Rehabilitation and Measurement of Approximation Force: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Rotator Cuff Tears; Serious Game
• Intervention / Treatment: Other: ConventioanalExercises; Other: Serious games

Detailed Description

Purpose: 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.

Method: Twenty patients with rotator cuff rupture will be included in the study. They will be divided into two groups as a serious game group (SGG) and a conventional exercise group (CEG) with a randomization method. The Serious game exercise program developed for shoulder rehabilitation will be applied to the SG group and conventional exercise training will be applied to the CEG. Pain severity, flexion, abduction and external rotation ROM, functionality, joint position sense, and approximation force of all individuals will be evaluated pre and post-treatment. SGG and CEG underwent serious games and conventional therapy twice a week for 6 weeks, respectively.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34820
    • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional exercise group; Conventional Exercises	Other: ConventioanalExercises; 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.
Experimental: Serious game group; Serious Games	Other: Serious games; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to evaluate the limitations and functionality of the individuals with upper extremity problems. The DASH that includes 30 questions and 3 sections is used to evaluate symptoms, parameters such as social function, work, sleep and self-confidence of patients.	5 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Serious game; Rotator cuff rupture; Shoulder Rehabilitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: Medipolftr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: When the study will be published in a journal, all of researchers can see the result of the participants of this study.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: Principle investigator

Drug and device information, study documents

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