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Clinical Trials/NCT05184309
NCT05184309
Completed
Not Applicable

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

Istanbul Medipol University Hospital1 site in 1 country40 target enrollmentJanuary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Serious Game
Sponsor
Istanbul Medipol University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Shoulder approximation force
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
March 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

burak menek

Principal investigator

Istanbul Medipol University Hospital

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

Outcomes

Primary Outcomes

Shoulder approximation force

Time Frame: 5 minutes

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°).

Pain assessment- Visual Analogue scale

Time Frame: 5 minutes

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

Time Frame: 5 minutes

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

Time Frame: 5 minutes

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.

Secondary Outcomes

  • The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(5 minutes)

Study Sites (1)

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