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

NCT03412708 | Unknown

• 1 other identifier: PamukkaleU
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness; Vestibular Rehabilitation; Virtual Reality

Outcome Measures

Primary Outcomes (4)

• Vertigo Symptom Scale (Short form)

  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.

  3 weeks

• Dizziness Handicap Inventory

  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 weeks

• Berg Balance Test

  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.

  3 weeks

• Dynamic Posturography

  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.

  3 weeks

Secondary Outcomes (4)

• Timed Up&Go (TUG) test

  3 weeks

• International Falls Efficacy Scale

  3 weeks

• Geriatric Depression Scale

  3 weeks

• Hamilton Anxiety Assessment Scale

  3 weeks

Study Arms (2)

Vestibular Rehabilitation

ACTIVE COMPARATOR

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

Vestibular Rehabilitation supported with Virtual Reality

EXPERIMENTAL

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

Interventions

Vestibular Rehabilitation supported with Virtual Reality OTHER

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.

Vestibular Rehabilitation; Vestibular Rehabilitation supported with Virtual Reality

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Medicine

Denizli, Turkey (Türkiye)

Location

Related Publications (31)

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  BACKGROUND

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Model Details: Prospective

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 26, 2018
• Study Start: May 23, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

TU (1)