Effects of Serious Games for Shoulder Rehabilitation
Primary Purpose
Serious Game, Rotator Cuff Tears, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ConventioanalExercises
Serious games
Sponsored by
About this trial
This is an interventional treatment trial for Serious Game focused on measuring Serious game, Rotator cuff rupture, Shoulder Rehabilitation
Eligibility Criteria
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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional exercise group
Serious game group
Arm Description
Conventional Exercises
Serious Games
Outcomes
Primary Outcome Measures
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.
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.
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.
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°).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05184309
First Posted
December 26, 2021
Last Updated
March 3, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05184309
Brief Title
Effects of Serious Games for Shoulder Rehabilitation
Official Title
Effects of Serious Games for Shoulder Rehabilitation and Measurement of Approximation Force: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serious Game, Rotator Cuff Tears, Rehabilitation
Keywords
Serious game, Rotator cuff rupture, Shoulder Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are blinded in enrollment and assessment process.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional exercise group
Arm Type
Experimental
Arm Description
Conventional Exercises
Arm Title
Serious game group
Arm Type
Experimental
Arm Description
Serious Games
Intervention Type
Other
Intervention Name(s)
ConventioanalExercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Serious games
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessment- Visual Analogue scale
Description
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.
Time Frame
5 minutes
Title
Range of motion
Description
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.
Time Frame
5 minutes
Title
Joint position sense
Description
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.
Time Frame
5 minutes
Title
Shoulder approximation force
Description
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°).
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
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.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Menek, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34820
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
When the study will be published in a journal, all of researchers can see the result of the participants of this study.
Citations:
PubMed Identifier
28446376
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28446376/
Description
Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/28446376/
Available IPD/Information Identifier
Principle investigator
Learn more about this trial
Effects of Serious Games for Shoulder Rehabilitation
We'll reach out to this number within 24 hrs