Effects of Serious Games for Shoulder Rehabilitation

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05184309
Collaborator
(none)
40
1
2
1.6
24.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ConventioanalExercises
  • Other: Serious games
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants are blinded in enrollment and assessment process.
Primary Purpose:
Treatment
Official Title:
Effects of Serious Games for Shoulder Rehabilitation and Measurement of Approximation Force: Randomized Controlled Trial
Actual Study Start Date :
Jan 10, 2022
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Mar 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain assessment- Visual Analogue scale [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.

  2. Range of motion [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.

  3. Joint position sense [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.

  4. Shoulder approximation force [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°).

Secondary Outcome Measures

  1. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [5 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Istanbul Turkey 34820

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Burak Menek, PhD, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
burak menek, Principal investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05184309
Other Study ID Numbers:
  • Medipolftr
First Posted:
Jan 11, 2022
Last Update Posted:
Mar 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by burak menek, Principal investigator, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022