Virtual Reality Approach in Multiple Sclerosis

NCT ID: NCT04212689

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-06-01

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.

Conditions

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Rehabilitation Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy and Rehabilitation

Intervention Type OTHER

The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.

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.

Group Type ACTIVE_COMPARATOR

Game Based Virtual Reality Exercises

Intervention Type 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.

Conventional Physiotherapy and Rehabilitation

Intervention Type OTHER

The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.

Interventions

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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.

Intervention Type DEVICE

Conventional Physiotherapy and Rehabilitation

The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nimet Sermenli Aydın, MSc

Role: PRINCIPAL_INVESTIGATOR

Marmara University Institute of Health Sciences

Dilara Merve Sari, MSc

Role: PRINCIPAL_INVESTIGATOR

Marmara University Institute of Health Sciences

Zubeyir Sari, Assoc Prof

Role: STUDY_DIRECTOR

Marmara University Faculty of Health Sciences

Locations

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Cadde Tıp Merkezi - Cadde Medical Center

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nimet Sermenli Aydın, MSc

Role: CONTACT

+905079955111

Halit Selcuk, MSc

Role: CONTACT

Facility Contacts

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Nimet Sermenli Aydin, MSc

Role: primary

References

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Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.

Reference Type BACKGROUND
PMID: 25206611 (View on PubMed)

Arman N, Tarakci E, Tarakci D, Kasapcopur O. Effects of Video Games-Based Task-Oriented Activity Training (Xbox 360 Kinect) on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2019 Mar;98(3):174-181. doi: 10.1097/PHM.0000000000001001.

Reference Type BACKGROUND
PMID: 30020092 (View on PubMed)

Burdea GC. Virtual rehabilitation--benefits and challenges. Methods Inf Med. 2003;42(5):519-23.

Reference Type BACKGROUND
PMID: 14654886 (View on PubMed)

Rubin BD, Kibler WB. Fundamental principles of shoulder rehabilitation: conservative to postoperative management. Arthroscopy. 2002 Nov-Dec;18(9 Suppl 2):29-39. doi: 10.1053/jars.2002.36507. No abstract available.

Reference Type BACKGROUND
PMID: 12426529 (View on PubMed)

Chen CC. Multimedia virtualized environment for shoulder pain rehabilitation. J Phys Ther Sci. 2016 Apr;28(4):1349-54. doi: 10.1589/jpts.28.1349. Epub 2016 Apr 28.

Reference Type BACKGROUND
PMID: 27190481 (View on PubMed)

Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.

Reference Type BACKGROUND
PMID: 8602410 (View on PubMed)

Bjartmar C, Trapp BD. Axonal and neuronal degeneration in multiple sclerosis: mechanisms and functional consequences. Curr Opin Neurol. 2001 Jun;14(3):271-8. doi: 10.1097/00019052-200106000-00003.

Reference Type BACKGROUND
PMID: 11371748 (View on PubMed)

Crayton H, Heyman RA, Rossman HS. A multimodal approach to managing the symptoms of multiple sclerosis. Neurology. 2004 Dec 14;63(11 Suppl 5):S12-8. doi: 10.1212/wnl.63.11_suppl_5.s12.

Reference Type BACKGROUND
PMID: 15596731 (View on PubMed)

Earhart GM, Cavanaugh JT, Ellis T, Ford MP, Foreman KB, Dibble L. The 9-hole PEG test of upper extremity function: average values, test-retest reliability, and factors contributing to performance in people with Parkinson disease. J Neurol Phys Ther. 2011 Dec;35(4):157-63. doi: 10.1097/NPT.0b013e318235da08.

Reference Type BACKGROUND
PMID: 22020457 (View on PubMed)

Feys P, Helsen W, Liu X, Mooren D, Albrecht H, Nuttin B, Ketelaer P. Effects of peripheral cooling on intention tremor in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):373-9. doi: 10.1136/jnnp.2004.044305.

Reference Type BACKGROUND
PMID: 15716530 (View on PubMed)

Hiller LB, Wade CK. Upper extremity functional assessment scales in children with Duchenne muscular dystrophy: a comparison. Arch Phys Med Rehabil. 1992 Jun;73(6):527-34.

Reference Type BACKGROUND
PMID: 1622300 (View on PubMed)

Peresedova AV, Chernikova LA, Zavalishin IA. [Physical rehabilitation in multiple sclerosis: general principles and high-tech approaches]. Vestn Ross Akad Med Nauk. 2013;(10):14-21. Russian.

Reference Type BACKGROUND
PMID: 24640715 (View on PubMed)

Other Identifiers

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31.10.2019/104

Identifier Type: -

Identifier Source: org_study_id

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