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The Effects of Vestibular Rehabilitation Therapy Supported With Virtual Reality in the Elderly Patients With Dizziness

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ClinicalTrials.gov Identifier: NCT03412708
Recruitment Status : Unknown
Verified January 2018 by Oya Topuz, Pamukkale University.
Recruitment status was:  Active, not recruiting
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Oya Topuz, Pamukkale University

Brief Summary:
Objective: To investigate the effect of vestibular rehabilitation exercises supported with virtual reality using virtual glasses technology on dizziness, static and dynamic balance, functional mobility, fear of falling, anxiety and depression in the short term (3 weeks) in the elderly with dizziness.

Condition or disease Intervention/treatment Phase
Dizziness Vestibular Rehabilitation Virtual Reality Other: Vestibular Rehabilitation supported with Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective
Masking: Single (Outcomes Assessor)
Masking Description: Single blind
Primary Purpose: Treatment
Official Title: The Effects of Vestibular Rehabilitation Therapy Supported With Virtual Reality on Dizziness and Balance in the Elderly Patients With Dizziness
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vestibular Rehabilitation

Vestibular Rehabilitation Program Exercises for Eye Movements: Smooth- Pursuit Eye Movements and Saccadic eye movements Exercises for Gaze Stability : Training of Vestibulo-ocular reflex and Cervico-ocular reflex Exercises for Postural Stability: In sitting or standing up position and walking

Duration of treatment: 3 weeks. Number of sessions: 15 Session frequency: 5 times a week. Session duration: 2 sets of 15 minutes, with a 5 minute break between sets, for a total of 35 minutes.

Other: Vestibular Rehabilitation supported with Virtual Reality
Patients will perform the supervised vestibular exercises in virtual reality environment using a virtual reality goggle (Samsung Gear VR SM323) and a smartphone (Samsung Galaxy S7). The virtual environments consist of 2 media provided by the videos taken with a 360 camera (Samsung Gear 360). 1) A square with people moving, noise and traffic and 2) A supermarket where the shelves are full.

Experimental: Vestibular Rehabilitation supported with Virtual Reality

Patients will perform the exercises in a virtual reality environment using a virtual reality goggle and a smartphone.The virtual environments consist of 2 media provided by the videos taken with a 360 camera . 1) A square with people moving, noise and traffic and 2) A supermarket where the shelves are full. Exercises conducted while sitting and standing on a soft ground will happen in the 1st environment, and the ones on the treadmill will happen in the 2nd environment.

Exercises for Eye Movements: Smooth- Pursuit Eye Movements and Saccadic eye movements Exercises for Gaze Stability : Training of Vestibulo-ocular reflex and Cervico-ocular reflex Exercises for Postural Stability: In sitting or standing up position and walking

Duration of treatment: 3 weeks. Number of sessions: 15 Session frequency: 5 times a week. Session duration: 2 sets of 15 minutes, with a 5 minute break between sets, for a total of 35 minutes.

Other: Vestibular Rehabilitation supported with Virtual Reality
Patients will perform the supervised vestibular exercises in virtual reality environment using a virtual reality goggle (Samsung Gear VR SM323) and a smartphone (Samsung Galaxy S7). The virtual environments consist of 2 media provided by the videos taken with a 360 camera (Samsung Gear 360). 1) A square with people moving, noise and traffic and 2) A supermarket where the shelves are full.




Primary Outcome Measures :
  1. Vertigo Symptom Scale (Short form) [ Time Frame: 3 weeks ]
    Vertigo Symptom Scale (Short form) is a questionnaire consisting of 15 items evaluating the frequency of dizziness and / or unbalance and accompanying autonomic and anxiety symptoms within the last 1 month.

  2. Dizziness Handicap Inventory [ Time Frame: 3 weeks ]
    The Dizziness Handicap Inventory , developed to measure disability in patients with dizziness and available for follow-up, is a questionnaire consisting of 25 questions about the physical, functional, and emotional state of the patient.

  3. Berg Balance Test [ Time Frame: 3 weeks ]
    Berg Balance Test includes activities such as unsupported seating, standing from a seating position, standing without support, picking up an item from the floor, turning 360 degrees, looking back over the shoulder, and transferring from the bed to the chair.

  4. Dynamic Posturography [ Time Frame: 3 weeks ]
    Biodex Balance System (Biodex, Inc., Shirley, New York) was used to evaluate the dynamic balance in elderly subjects Postural stability tests and the risk of falls (General Stability Index, Medio-lateral Stability Index, Antero-posterior Stability Index, Falling Risks Index) were calculated.


Secondary Outcome Measures :
  1. Timed Up&Go (TUG) test [ Time Frame: 3 weeks ]
    Timed Up&Go (TUG) test was used to assess functional mobility.

  2. International Falls Efficacy Scale [ Time Frame: 3 weeks ]
    International Falls Efficacy Scale: The test consists of 16 questions that assess patients' anxiety about the possibility of falls during their daily activities.

  3. Geriatric Depression Scale [ Time Frame: 3 weeks ]
    Geriatric Depression Scale consists of a total of thirty closed-ended questions. The answers are calculated as "1" point for each question if answered in a depressed way, and the sum of these points and the total score are calculated.

  4. Hamilton Anxiety Assessment Scale [ Time Frame: 3 weeks ]
    Hamilton Anxiety Assessment Scale questions the anxiety severity, psychological and somatic symptoms. severity of anxiety



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Living in society
  2. Being able to stand up and walk by themselves, without needing a supporting device
  3. Consulting an otolaryngologist with the complaint of dizziness.

Exclusion Criteria:

  1. Presence of cognitive dysfunction
  2. Presence of musculoskeletal or systemic disease that prevents exercise.
  3. Having an exercise program in the last 6 months,
  4. Presence of psychiatric or neurological diseases that affect cooperation and cognitive functions in their history,
  5. Presence of neurological disease that affects balance in their history,
  6. Positive Dix-Hallpike test,
  7. Patients with a Vit D level lower than 30 ng /ml.

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): NCT03412708


Locations
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Turkey
Pamukkale University Faculty of Medicine
Denizli, Turkey
Sponsors and Collaborators
Pamukkale University
Publications:
Ellialtıoğlu A, Karan A, İşsever H, Aksoy C. Validity and reliability of Turkish version of Dizziness Handicap Inventory (DHI). XVIII National Physical Medicine and Rehabilitation Congress, May 12-17, 2001, Antalya, Program and Abstract Book; 2001. p. 131
Baldwin, S.L., T.W. VanArnam,L.L. Ploutz-Snyder. Reliability of dynamic bilateral postural stability on the Biodex Stability System in older adults. Medicine & Science in Sports & Exercise, 2004(36):30
Parraca, J.A., Olivares, P.R., Carbonell-Baeza, A., Aparicio, V.A., Adsuar, J.C., Gusi, N. Test-retest reliability of Biodex Balance SD on physically active old people. J Hum Sport Exerc. 2011;6:444-451
Ertan T, Eker E, Sar V. Geriatrik Depresyon Ölçegi'nin Türk Yaslı Nüfusunda Geçerlilik ve Güvenilirligi. Nöropsikiyatri Arsivi 1997; 34(2): 62-71
Yazıcı MK, Demir B, Tanrıverdi N, Karaağaoğlu E, Yolaç¸ P. Hamilton Anksiyete Değerlendirme Ölçeği Değerlendiriciler Arası Güvenilirlik ve Geçerlilik Çalışması. Türk Psikiyatri Dergisi 1998;9:114-7

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Responsible Party: Oya Topuz, MD, Professor, Pamukkale University
ClinicalTrials.gov Identifier: NCT03412708    
Other Study ID Numbers: PamukkaleU
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Dizziness
Sensation Disorders
Neurologic Manifestations
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases