Virtual Reality Approach in Subacromial Impingement Syndrome

NCT03912493 | Unknown

• 1 other identifier: 29.11.2016/36
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome; Virtual Reality; Rehabilitation; Subacromial Impingement Syndrome

Keywords

Subacromial Impingement Syndrome; Physiotherapy and Rehabilitation; Virtual Reality; Technologic Rehabilitation

Outcome Measures

Primary Outcomes (9)

• Change in range of motion from baseline to week 4

  The range of motion of the joints in the upper extremities will be measured using the universal goniometer before and after the treatment.

  4 weeks

• Change in level of pain from baseline to week 4

  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''.

  4 weeks

• Change in disability of the upper extremity from baseline to week 4

  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 weeks

• Change in quality of shoulder function from baseline to week 4

  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).

  4 weeks

• Change in muscle strength from baseline to week 4

  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.

  4 weeks

• Change in pain threshold from baseline to week 4

  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.

  4 weeks

• Change in proprioception from baseline to week 4

  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.

  4 weeks

• Change in kinesiophobia from baseline to week 4

  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.

  4 weeks

• Satisfaction of the Treatment

  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''.

  4 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Study Group

ACTIVE COMPARATOR

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; Other: Conventional Physiotherapy and Rehabilitation

Interventions

Game Based Virtual Reality Exercises DEVICE

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.

Study Group

Conventional Physiotherapy and Rehabilitation OTHER

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.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Cadde Tıp Merkezi - Cadde Medical Center

Istanbul, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Berivan Beril KILIC, MSc, PT

  Marmara University Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Zübeyir SARI, Assoc Prof

  Marmara University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Dilara Merve SARI, MSc, PT

CONTACT

+905333444601; dilaramervesari@gmail.com

Nimet SERMENLI AYDIN, MSc, PT

CONTACT

nimetsermenli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)