Virtual Reality Approach in Multiple Sclerosis

Study Overview
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Brief Summary
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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 Multiple Sclerosis (MS). In order to evaluate its effectiveness, assessment of pain, range of motion and disability will be applied.

Detailed Description
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Multiple Sclerosis (MS) is a neuromuscular disease that causes various degrees of disability in mobility and functional activities, causing restrictions on the individual's social and professional life, creating advanced disability and impairing quality of life. Problems in upper limb function 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 MS 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. 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 MS.

Official Title
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The Effectiveness of Game-Based Virtual Reality Approach in Patients With Multiple Sclerosis

Conditions
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Rehabilitation, Multiple Sclerosis

Intervention / Treatment
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* Device: Game Based Virtual Reality Exercises
* Other: Conventional Physiotherapy and Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteered to participate in the study, Aged 18-65 years Having a score between 1.5 - 7 according to Expanded Disability Status Scale (EDSS) 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 Not being stable for MS attacks during the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Number of participants in this group is anticipated to be 20. Conventional physiotherapy and rehabilitation methods will be applied to this group. Physiotherapy approaches include stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy. | Other: Conventional Physiotherapy and Rehabilitation<br>* The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.<br>|
| Active Comparator: Study Group<br>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<br>* 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.<br>Other: Conventional Physiotherapy and Rehabilitation<br>* The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 disability of the fingers from baseline to week 4 | The Nine-Hole Peg Test (9HPT) will be used to measure finger dexterity. The test is administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the test activity, recorded in seconds. | 4 weeks | 
| Change in spasticity from baseline to week 4 | Spasticity will be defined with Modified Ashworth Scale (MAS). The MAS measures resistance during passive soft-tissue stretching. Scoring: 0= normal tone. 1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension. 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM. 2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3= considerable increase in muscle tone, passive movement difficult. 4= affected part(s) rigid in flexion or extension. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Physiotherapy and Rehabilitation, Virtual Reality, Multiple Sclerosis, Upper extremity