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Virtual Reality Approach in Subacromial Impingement Syndrome

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ClinicalTrials.gov Identifier: NCT03912493
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Marmara University

Study Description
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Brief Summary:
The aim of our study is to investigate the effects of game-based virtual reality exercise added to conventional physiotherapy and rehabilitation program in patients with Subacromial Impingement Syndrome (SIS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.

Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Virtual Reality Rehabilitation Subacromial Impingement Syndrome Device: Game Based Virtual Reality Exercises Other: Conventional Physiotherapy and Rehabilitation Not Applicable

Detailed Description:
Subacromial Impingement Syndrome (SIS) is the result of contraction of the structures passing through the subacromial area. Problems in upper limb function in people with SIS adversely affect quality of life and functional independence of the patients. Recovery of restricted daily life functions (such as dressing, personal care, eating and body care) is one of the main goals of physiotherapy and rehabilitation in SIS and currently, conventional physiotherapy and rehabilitation methods are most commonly used. The main purpose of this method is to reduce pain, increase range of motion and muscle strength. With the developing technology various virtual reality applications have begun to take place in physiotherapy and rehabilitation programs recently. These virtual reality applications are used to motivate the patient and keep their interest in the rehabilitation. In addition, the diversity of virtual reality applications is increasing day by day so that participation of the patients and the interest in the treatment can be increased. Various measurements of the user's performance can be transferred to the clinician simultaneously with these systems. Also for most of these systems exercise modes, difficulty and duration are programmable so that the training sessions can be varied. The aim of our study is to investigate the effects of game-based virtual reality exercises added to conventional physiotherapy and rehabilitation program in patients with SIS.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Game-Based Virtual Reality Approach in Patients With Subacromial Impingement Syndrome
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Group
Number of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. The conventional program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.
 Other: Conventional Physiotherapy and Rehabilitation
The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.
Active Comparator: Study Group
Number of participants in this group is anticipated to be 20. Participants in this group will be receiving conventional physiotherapy and rehabilitation methods and 10 minutes of exercise with the game-based virtual reality system (USE-IT). In the USE-IT system two games will be played for 5 minutes each.
 Device: Game Based Virtual Reality Exercises
A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.

Other: Conventional Physiotherapy and Rehabilitation
The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.


Outcome Measures
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Primary Outcome Measures :
  1. Change in range of motion from baseline to week 4 [ Time Frame: 4 weeks ]
    The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.

  2. Change in level of pain from baseline to week 4 [ Time Frame: 4 weeks ]
    Level of Pain will be assessed with Visual Analogue Scale (VAS). It is widely used among the methods of measuring the severity of pain. Scale is a 10 cm ruler, participants will mark the level of pain between 0-10 cm, 0 would means ''no pain'' and 10 would means ''worst possible pain''.

  3. Change in disability of the upper extremity from baseline to week 4 [ Time Frame: 4 weeks ]
    Disability of the upper extremities will be assessed with 'The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire'. It is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time.

  4. Change in quality of shoulder function from baseline to week 4 [ Time Frame: 4 weeks ]
    Quality of function of the shoulder will be assessed with Constant-Murley Score. It is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. Pain (15 points), daily living activities (20 points), active range of motion (40 points) and force (25 points) parameters, including a total of 100 points system. The total Constant score is classified as excellent (30 <), good (21 - 30), medium (11 - 20) and weak (<11).

  5. Change in muscle strength from baseline to week 4 [ Time Frame: 4 weeks ]
    The muscle strength of shoulder flexion, abduction, adduction, external and internal rotation movements will be evaluated by using the Baseline Push-Pull (New York) dynamometer. Results will be calculated in kg (1 lb = 0.454 kg). The patient's arm will be stabilized and the patient will be asked to show maximum resistance within 2 sec against the dynamometer placed and then hold it for 5 seconds at this position and power. The measurement will be repeated twice and recorded with the average of these two values.

  6. Change in pain threshold from baseline to week 4 [ Time Frame: 4 weeks ]
    The pain threshold will be measured with a digital algometer device. Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.

  7. Change in proprioception from baseline to week 4 [ Time Frame: 4 weeks ]
    Proprioception will be evaluated with 'Marmara Visual Auditory Joint Education Device (MarVAJED) which was developed by the Faculty of Health Sciences of Marmara University, Istanbul. This device evaluates motion deficits of joints, analyzes joint position sense, provides biofeedback support to increase joint control and also directs to controlled exercises. It analyzes the motion of the joint with the help of small sensors and transfers the data obtained to the mobile phone, tablet or computer.

  8. Change in kinesiophobia from baseline to week 4 [ Time Frame: 4 weeks ]
    In the assessment of kinesiophobia 'Tampa Kinesiophobia Scale (TKS)' will be used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury.

  9. Satisfaction of the Treatment [ Time Frame: 4 weeks ]
    An objective test that evaluates the satisfaction of the patient from pain status, functionality, treatment and physiotherapist after treatment will be assessed with 4 questions, and each question is given a score of 0-10 using the VAS scale. 0 means ''I am not satisfied at all'', 10 means ''I am very satisfied''.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Volunteered to participate in the study
  • Aged 18-65 years,

Exclusion Criteria:

  • Any visual or hearing problem,
  • Other neurological, orthopedic or rheumatic problems that may restrict shoulder motion or cause pain,
  • Having a physical disability or uncontrolled chronic systemic disease,
  • Major trauma,
  • Treatment for shoulder problems within the last 6 months,
  • History of epileptic attacks
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912493


Contacts
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Contact: Dilara Merve SARI, MSc, PT +905333444601 dilaramervesari@gmail.com
Contact: Nimet SERMENLI AYDIN, MSc, PT nimetsermenli@gmail.com

Locations
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Turkey
Cadde Tıp Merkezi - Cadde Medical Center Recruiting
Istanbul, Turkey
Contact: Nimet Sermenli Aydin, MSc         
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Berivan Beril KILIC, MSc, PT Marmara University Institute of Health Sciences
Study Director: Zübeyir SARI, Assoc Prof Marmara University Faculty of Health Sciences
  Study Documents (Full-Text)

Documents provided by Marmara University:
Study Protocol and Statistical Analysis Plan  [PDF] April 8, 2019

More Information
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Publications:

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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03912493    
Other Study ID Numbers: 29.11.2016/36
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
Subacromial Impingement Syndrome
Physiotherapy and Rehabilitation
Virtual Reality
Technologic Rehabilitation
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
 Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases