Clinical trial NCT05184309: 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
Overall status: COMPLETED
Phase: NA
Conditions: Serious Game
Rotator Cuff Tears
Rehabilitation
Keywords: Serious game
Rotator cuff rupture
Shoulder Rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain assessment- Visual Analogue scale
timeFrame: 5 minutes
measure: Range of motion
timeFrame: 5 minutes
measure: Joint position sense
timeFrame: 5 minutes
measure: Shoulder approximation force
timeFrame: 5 minutes
Secondary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Burak Menek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.