Effects of Serious Games for Shoulder Rehabilitation

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184309
• Other study ID #: Medipolftr
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rehabilitation
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Serious Game

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

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