Clinical trial NCT04212689: Virtual Reality Approach in Multiple Sclerosis
Official title: The Effectiveness of Game-Based Virtual Reality Approach in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Multiple Sclerosis
Keywords: Rehabilitation
Physiotherapy and Rehabilitation
Virtual Reality
Multiple Sclerosis
Upper extremity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in range of motion from baseline to week 4
timeFrame: 4 weeks
measure: Change in level of pain from baseline to week 4
timeFrame: 4 weeks
measure: Change in disability of the upper extremity from baseline to week 4
timeFrame: 4 weeks
measure: Change in pain threshold from baseline to week 4
timeFrame: 4 weeks
measure: Change in proprioception from baseline to week 4
timeFrame: 4 weeks
measure: Change in kinesiophobia from baseline to week 4
timeFrame: 4 weeks
measure: Satisfaction of the Treatment
timeFrame: 4 weeks
measure: Change in muscle strength from baseline to week 4
timeFrame: 4 weeks
measure: Change in disability of the fingers from baseline to week 4
timeFrame: 4 weeks
measure: Change in spasticity from baseline to week 4
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cadde Tıp Merkezi - Cadde Medical Center
Study officials:
affiliation: Marmara University Institute of Health Sciences
name: Nimet Sermenli Aydın, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University Institute of Health Sciences
name: Dilara Merve Sari, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University Faculty of Health Sciences
name: Zubeyir Sari, Assoc Prof
role: STUDY_DIRECTOR
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