DizzinessNCT03412708
The Effects of Vestibular Rehabilitation Therapy Supported With Virtual Reality in the Elderly Patients With Dizziness
A study testing Vestibular Rehabilitation supported with Virtual Reality in people with Dizziness and Vestibular Rehabilitation, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dizziness, Vestibular Rehabilitation, Virtual Reality
- What is being tested?
- Vestibular Rehabilitation supported with Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Medicine
Denizli
About this study
Official title: The Effects of Vestibular Rehabilitation Therapy Supported With Virtual Reality on Dizziness and Balance in the Elderly Patients With Dizziness
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.
Read the detailed description
INTRODUCTION:
Dizziness, is a condition that includes spatial orientation and motion perception disorder symptoms such as swivel illusion or sensation of instability, which can affect gaze stability, posture and walking. This problem is seen in about 30% of the elderly living in society and the prevalence increases with age (1). Patients with history of dizziness have limitations in daily activities, increased fear of falling, increased anxiety and depression, decreased quality of life, and increased risk of falls (2,3).
It has been shown that vestibular rehabilitation programs including postural control and balance exercises as well as recurrent head, eye, and trunk movements have positive effects on dizziness, balance and falling risk in the elderly (4,5).
Exercise programs are often performed in the clinical setting or at home, and participation in the exercise program of real-life environments such as a street, supermarket, park, workplace, where traffic is available can make a difference in patient motivation and exercise effectiveness. Positive effects on walking, postural control, balance and mobility in the elderly have been reported with exercises in the form of interactive games such as "Nintendo Wii", "Balance Rehabilitation Unit", dance video games where virtual reality technologies are used (6-10). There was no study investigating the effects of virtual reality created by virtual glasses and smartphone technology, on balance, functional mobility, falling risk, anxiety and depression in the elderly.
The objective of this study is 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.
METHOD:
Research Design:
Single-blind, randomized, controlled, single-center, prospective, experimental study in patients aged 65 years and older who applied to the otorhinolaryngology clinic with dizziness complaint and 6-month follow-up period.
Target Research Group: Patients 65 years of age or older who meet the inclusion criteria below.
Inclusion Criteria: 1) Living in society 2) Being able to stand up and walk by themselves, without needing a supporting device 3) Applying to the otorhinolaryngology clinic with dizziness complaint. Patients with any of the exclusion criteria listed below will be excluded from the study.
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.
Beginning Screening Assessments are ,illness inquiry, inquiring about used medication, cigarette and alcohol, history of falling.
The following questions were asked about the fall of the patient and their answers were recorded.
How many times did you fall in the last 6 months? Where did you fall? How did you fall? Were you injured? Were you admitted to the hospital?
Assessment of Cognitive Function by Mini Mental Test:
It was first published by Folstein and his friends. The test is a short, useful and standardized tool that can be used when assessing the cognitive level globally. The orientation is made up of eleven items grouped under five main headings as recording memory, attention and calculation, recall and language, and is evaluated over the total score of 30 (11). In this study, revised Mini Mental State Scale, whose Turkish validity and reliability studies were done by Keskinoğlu et al., was used in educated and uneducated elderly. Cut-off value was accepted as 24 for educated and 19 for uneducated elderly, as indicated by the researchers (12).
Assessing eye movements and visual acuity:
Eye movements: They were asked to make eye movements in all directions.
Smooth pursuit eye movements:
The patient was asked to watch the index finger of the examiner slowly moving up or down, left or right, with their eye. The patient must be able to see the index finger clearly, the finger should not move more than 60 degrees from one side to the other, and the speed should not be more than 40 degrees per second.
Saccadic eye movements:
The patient was asked to look at the fingers separated from each other by vertical and horizontal planes at a distance of 30 cm. During this time, attention was paid to latency, speed, accuracy and parallelism (conjugation) in the movement of the eyes.
Visual Acuity:
Assessed using a Snellen Chart.
Somatosensorial assessment:
Lower extremity muscle strength Lower extremity muscle strength was assessed with Chair Stand Test. This test was performed by Jones et al. and has been shown to be a valid and reliable measure of the proximal muscle strength of the lower extremities in elderly individuals. In the starting position the person is sitting on a chair without armrests and with their back upright, their arms crossed in front of their chest and their feet on the floor. With the start command, the person does a full standing position and is seated again, the total number of full stands in 30 seconds constitutes their score (13).
Lower extremity sense:
On the lower extremity sensory examination, the light touch sensation was assessed by cotton, the pain sensation by a needle, and the deep sensation by the sensation of the thumb position.
Cerebellar Assessment:
Finger - Nose Test The patient touches their nose with their index finger after touching the index finger of the doctor sitting opposite them. While repeating this movement in succession, the physician changes the position of his finger every time. The results were scored as successful / unsuccessful.
Knee - Heel Test It is examined with the patient laying on their back. After the patient touches their knee with their heel, they lower the foot down on a straight line along the tibia bone. After repeating this movement several times, they do the same with the other foot. The results were scored as successful / unsuccessful.
Alternating Movement Tests The patient is made to do quick alternating movements. The patient opens a hand with the palm up. The back of the other hand and the palmar face touch the open palm with rapid repetitive pronation-supination movements. The results were scored as successful / unsuccessful.
Pulse:
Blood pressure:
Orthostatic hypotension:
Postural blood pressure measurement; the first blood pressure was measured after they had been laying on their back for at least five minutes, the second blood pressure was measured as soon as they stood up and third blood pressure was measured after standing on their feet and waiting for three minutes with a manometer. A fall of 20mmHg relative to the lying position in the systolic blood pressure after standing on their feet and after standing for three minutes was considered significant for orthostatic hypotension (14).
Vit D Level:
Calculation of Sample Size:
The sample size was calculated as the minimum number of subjects required for each of the arms so that a difference of 3.73 units between the two group averages in the Berg Balance Scale (Type 1 error: 0,05, Type 2 error: 0,20) could be significant according to the results of the previous study. The number of subjects in each group will be a minimum of 16(15).
Randomisation and treatment:
Patients who meet the inclusion criteria after initial screening and do not have exclusion criteria will be divided into two groups by layered block randomization and 2 different treatment protocols will be applied. Patients were planned to be included so that at least 16 patients would be in each group.
Group 1: Supervised vestibular rehabilitation program in clinical setting. Group 2: Supervised vestibular rehabilitation program supported with virtual reality
For both groups; 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.
Patients who do not attend at least 3 sessions in the same week will be dropped from the study.
Patients in Group 2 will perform the exercises in a 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. 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.
During the exercises, assisted ambulation system (Biodex Free Step SAS) will be used to ensure the safety of the patient and to prevent falls.
All patients will be trained initially by a physician for 30 minutes, including a definition of fall, definition of prevention, risk factors, information on prevention, and recommendations for preventing falls.
Vestibular Rehabilitation Program
2 sets of 15 minutes; each set will include the following exercises for a total of a 35 minute program.
Exercises for Eye Movements
Smooth- Pursuit Eye Movements:
The patient is asked to move their eyes at first slowly and then quickly in horizontal and vertical directions (10 times). In the 1st week while sitting, in the 2nd week while standing and in the 3rd week while standing on a soft ground.
Saccadic eye movements:
The patient is asked to focus by moving their eyes 1 time per second to 2 targets 30 cm away from each other (10 times). Motion is applied in horizontal and vertical directions. While sitting on the 1st week, standing on the 2nd week, and standing on soft ground for the 3rd week.
Exercises for Gaze Stability
Training of Vestibulo-ocular reflex:
- The patient is asked to move their head first in horizontal, then in vertical directions for 1 minute, focusing on a fixed object. While sitting on the 1st week, standing on the 2nd week, and standing on soft ground for the 3rd week.
- The patient is asked to move their head first in horizontal, then in vertical directions for 1 minute, focusing on a moving object. While sitting on the 1st week, standing on the 2nd week, and standing on soft ground for the 3rd week.
Training of Cervico-ocular reflex The patient sitting on a rotating chair is asked to move their torso to the right and left, keeping his head steady by focusing on a fixed object (10 times). It is conducted in the 1st and 2nd weeks.
Exercises for Postural Stability
Standing up:
- Week: Bend forward and side to side while sitting, pass from sitting position to standing position and back to sitting position (10 times), standing in various positions (feet together, tandem position) (15 sec), marching in place (10 times) is requested.
- Week: Bending their body front and back, and to their sides (10 front and back, 10 to the sides) while standing, standing in various positions (feet together, tandem position) (15 sec), marching in place (10 times) is requested.
- Week The exercises in the 2nd week is conducted on soft ground.
Walking:
Patients conduct their exercises while walking at a pace of 1.6km/h on the treadmill.
- Week: They are asked to walk forward on the treadmill (1 min)
- Week: They are asked to walk on the treadmill while moving their head left-right, front-back (1 min)
- Week:
They are asked to walk on the treadmill while focusing on a fixed object and moving their heads first horizontally and then vertically (1 min)
Assessment Parameters
Dizziness Assessment
Vertigo Symptom Scale (Short form):
It 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. Each item is scored between 0-4 and the scores of all items are summed to obtain the symptom severity score. The total score is between 0 and 60, higher scores indicate a more serious problem. A total score of 12 or more indicates severe dizziness. The scale consists of 8 items related to vertigo-balance, scored between 0-32 points (VSS-V), and 7 items related to autonomic-anxiety symptoms and 2 scales scored between 0-28 points (VSS-A) (16,17). The validity and reliability studies of the Turkish version were made by Yanık et al. (18).
Dizziness Disability Inventory:
The Dizziness Disability Inventory (DDI), 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. There are nine items each that determine the emotional state and functional status and seven items that determine the physical function. If the answers to the questions are "yes", they are scored as four points, "sometimes" as two points, and "no" as zero points. The maximum score for the emotional and functional subgroups is 36, and for the physical function subgroup the maximum score is 28, with a maximum score of 100 in total. The minimum score for all subgroups and total score is zero. High score indicates more disability (19). The validity and reliability studies of the Turkish version were made by Ellialtıoğlu and their colleagues (20).
Balance Assessment
Berg Balance Test:
The Berg balance test (BBT), which was developed by Berg et al. in 1989 and proved to be valid and reliable in 1992, was used as a clinical balance test. This 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. In BBT, the level of qualification for each item is scored from zero to four, where 0 means "can not do it"; and 4 means "can do it independently and safely". The total maximum score is 56 and the higher scores show a better balance (21). Şahin et al. showed that the Turkish version of the Berg balance test was a reliable and valid scale for assessing balance in elderly adults (22).
Dynamic Posturography Biodex Balance System (Biodex, Inc., Shirley, New York) was used to evaluate the dynamic balance in elderly subjects (23,24). Postural stability tests and the risk of falls (General Stability Index, Medio-lateral Stability Index, Antero-posterior Stability Index, Falling Risks Index) were calculated. There is a balance platform of this system in relation to a computer software that allows moving, balanced, objective evaluation of the system, which can be tilted up to 20 ° at a 360 ° range of motion. The overall stability score refers to the balance ability of the person in general and high values indicate that the balance is bad. Patients are tested on the platform at the 8th level, with the eyes open and on both feet, while the feet are naked and the person is in the most comfortable position where they can keep their balance, their knees are at the slightest flexion (15º). After a 20-second trial test, each person was subjected to three 20-second tests. A 10-second rest period was provided between each test, and as a result, averages of these three tests were obtained.
Functional Mobility Assessment
TUG:
Timed Up\&Go (TUG) test was used to assess functional mobility. In this test the elapsed time is measured in seconds for the individual to get up from the sitting position, walk a three meter distance and return. During the test, the standard chair with armrests should have a tape, cone or other clear marker indicating the end of the distance and the person should be wearing walking shoes they are used to and if they use a supportive device such as a walker or crutches, this should be noted and also used during the test (25).
Assessment of fear of falling:
International Falls Efficacy Scale:
The test described by Yardley et al. in 2005 consists of 16 questions that assess patients' anxiety about the possibility of falls during their daily activities. Each question is scored between 0-4 in itself (26). The validity and reliability study in Turkish for the elderly population was conducted (27).
Anxiety/Depression Assessment Geriatric Depression Scale To assess depression, we used Geriatric Depression Scale (GDS) developed by Yesavage and colleagues to screen for depression in the elderly population. The 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. The high scores indicate depressive characteristics. The total score is thirty, with the scores meaning no depression between 0-11, possible depression between 11-14, and definite depression for 14 and over (28). The validity and reliability of the GDS has been proven by translating it into Turkish by Ertan and his colleagues (29).
Hamilton Anxiety Assessment Scale:
This scale, developed by Hamilton, questions the anxiety severity, psychological and somatic symptoms. In the 14 questions, topics such as anxious temperament, tension, fear, insomnia, intellectual status, depressive temperament, body symptoms, somatic symptoms, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms and behaviours during the interview are questioned. When each of the 14 items are assessed, a score of 0-4 is given (0=none, 1=mild, 2=medium, 3=severe, 4=very severe) and the patients are evaluated based on the scores they receive in the overall total. The higher the score, the higher the severity of anxiety. The total score is between 0-56, below 17 is mild, between 18-24 is moderate and 25-30 is severe (30). Reliability and validity studies in Turkey were made by Yazıcı and his colleagues (31).
- Conditions
- Dizziness, Vestibular Rehabilitation, Virtual Reality
- Being tested
- Vestibular Rehabilitation supported with Virtual Reality
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation supported with Virtual RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Vestibular Rehabilitation supported with Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Secondary outcomes (4)
Timed Up&Go (TUG) test
Timed Up\&Go (TUG) test was used to assess functional mobility.
Measured: 3 weeks
International Falls Efficacy Scale
International Falls Efficacy Scale: The test consists of 16 questions that assess patients' anxiety about the possibility of falls during their daily activities.
Measured: 3 weeks
Geriatric Depression Scale
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.
Measured: 3 weeks
Hamilton Anxiety Assessment Scale
Hamilton Anxiety Assessment Scale questions the anxiety severity, psychological and somatic symptoms. severity of anxiety
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start23 May 2017
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oya Topuz, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412708
- Sponsor's protocol ID
- PamukkaleU
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fernandez L, Breinbauer HA, Delano PH. Vertigo and Dizziness in the Elderly. Front Neurol. 2015 Jun 26;6:144. doi: 10.3389/fneur.2015.00144. eCollection 2015.
PubMed 26167157Salles N, Kressig RW, Michel JP. Management of chronic dizziness in elderly people. Z Gerontol Geriatr. 2003 Feb;36(1):10-5. doi: 10.1007/s00391-003-0141-x.
PubMed 12616402Lo AX, Harada CN. Geriatric dizziness: evolving diagnostic and therapeutic approaches for the emergency department. Clin Geriatr Med. 2013 Feb;29(1):181-204. doi: 10.1016/j.cger.2012.10.004.
PubMed 23177607Yang XJ, Hill K, Moore K, Williams S, Dowson L, Borschmann K, Simpson JA, Dharmage SC. Effectiveness of a targeted exercise intervention in reversing older people's mild balance dysfunction: a randomized controlled trial. Phys Ther. 2012 Jan;92(1):24-37. doi: 10.2522/ptj.20100289. Epub 2011 Oct 6.
PubMed 21979272Jung JY, Kim JS, Chung PS, Woo SH, Rhee CK. Effect of vestibular rehabilitation on dizziness in the elderly. Am J Otolaryngol. 2009 Sep-Oct;30(5):295-9. doi: 10.1016/j.amjoto.2008.06.013. Epub 2009 Feb 6.
PubMed 19720245Duque G, Boersma D, Loza-Diaz G, Hassan S, Suarez H, Geisinger D, Suriyaarachchi P, Sharma A, Demontiero O. Effects of balance training using a virtual-reality system in older fallers. Clin Interv Aging. 2013;8:257-63. doi: 10.2147/CIA.S41453. Epub 2013 Feb 28.
PubMed 23467506Toulotte C, Toursel C, Olivier N. Wii Fit(R) training vs. Adapted Physical Activities: which one is the most appropriate to improve the balance of independent senior subjects? A randomized controlled study. Clin Rehabil. 2012 Sep;26(9):827-35. doi: 10.1177/0269215511434996. Epub 2012 Feb 9.
PubMed 22324055Pichierri G, Murer K, de Bruin ED. A cognitive-motor intervention using a dance video game to enhance foot placement accuracy and gait under dual task conditions in older adults: a randomized controlled trial. BMC Geriatr. 2012 Dec 14;12:74. doi: 10.1186/1471-2318-12-74.
PubMed 23241332Laver K, George S, Ratcliffe J, Quinn S, Whitehead C, Davies O, Crotty M. Use of an interactive video gaming program compared with conventional physiotherapy for hospitalised older adults: a feasibility trial. Disabil Rehabil. 2012;34(21):1802-8. doi: 10.3109/09638288.2012.662570. Epub 2012 Mar 12.
PubMed 22409245Szturm T, Betker AL, Moussavi Z, Desai A, Goodman V. Effects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trial. Phys Ther. 2011 Oct;91(10):1449-62. doi: 10.2522/ptj.20090205. Epub 2011 Jul 28.
PubMed 21799138Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Keskinoglu P, Ucku R, Yener G, Yaka E, Kurt P, Tunca Z. Reliability and validity of revised Turkish version of Mini Mental State Examination (rMMSE-T) in community-dwelling educated and uneducated elderly. Int J Geriatr Psychiatry. 2009 Nov;24(11):1242-50. doi: 10.1002/gps.2252.
PubMed 19337986Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Kaufmann H. Consensus statement on the definition of orthostatic hypotension, pure autonomic failure and multiple system atrophy. Clin Auton Res. 1996 Apr;6(2):125-6. doi: 10.1007/BF02291236. No abstract available.
PubMed 8726100Karahan AY, Tok F, Taskin H, Kucuksarac S, Basaran A, Yildirim P. Effects of Exergames on Balance, Functional Mobility, and Quality of Life of Geriatrics Versus Home Exercise Programme: Randomized Controlled Study. Cent Eur J Public Health. 2015 Nov;23 Suppl:S14-8. doi: 10.21101/cejph.a4081.
PubMed 26849537
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vestibular Rehabilitation Therapy Supported With Virtual Reality on Dizziness and Balance in the Elderly Patients With Dizziness
- ClinicalTrials.gov ID
- NCT03412708
- Acronym / sponsor ID
- PamukkaleU
- Conditions
- Dizziness, Vestibular Rehabilitation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTRODUCTION:
Dizziness, is a condition that includes spatial orientation and motion perception disorder symptoms such as swivel illusion or sensation of instability, which can affect gaze stability, posture and walking. This problem is seen in about 30% of the elderly living in society and the prevalence increases with age (1). Patients with history of dizziness have limitations in daily activities, increased fear of falling, increased anxiety and depression, decreased quality of life, and increased risk of falls (2,3).
It has been shown that vestibular rehabilitation programs including postural control and balance exercises as well as recurrent head, eye, and trunk movements have positive effects on dizziness, balance and falling risk in the elderly (4,5).
Exercise programs are often performed in the clinical setting or at home, and participation in the exercise program of real-life environments such as a street, supermarket, park, workplace, where traffic is available can make a difference in patient motivation and exercise effectiveness. Positive effects on walking, postural control, balance and mobility in the elderly have been reported with exercises in the form of interactive games such as "Nintendo Wii", "Balance Rehabilitation Unit", dance video games where virtual reality technologies are used (6-10). There was no study investigating the effects of virtual reality created by virtual glasses and smartphone technology, on balance, functional mobility, falling risk, anxiety and depression in the elderly.
The objective of this study is 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.
METHOD:
Research Design:
Single-blind, randomized, controlled, single-center, prospective, experimental study in patients aged 65 years and older who applied to the otorhinolaryngology clinic with dizziness complaint and 6-month follow-up period.
Target Research Group: Patients 65 years of age or older who meet the inclusion criteria below.
Inclusion Criteria: 1) Living in society 2) Being able to stand up and walk by themselves, without needing a supporting device 3) Applying to the otorhinolaryngology clinic with dizziness complaint. Patients with any of the exclusion criteria listed below will be excluded from the study.
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.
Beginning Screening Assessments are ,illness inquiry, inquiring about used medication, cigarette and alcohol, history of falling.
The following questions were asked about the fall of the patient and their answers were recorded.
How many times did you fall in the last 6 months? Where did you fall? How did you fall? Were you injured? Were you admitted to the hospital?
Assessment of Cognitive Function by Mini Mental Test:
It was first published by Folstein and his friends. The test is a short, useful and standardized tool that can be used when assessing the cognitive level globally. The orientation is made up of eleven items grouped under five main headings as recording memory, attention and calculation, recall and language, and is evaluated over the total score of 30 (11). In this study, revised Mini Mental State Scale, whose Turkish validity and reliability studies were done by Keskinoğlu et al., was used in educated and uneducated elderly. Cut-off value was accepted as 24 for educated and 19 for uneducated elderly, as indicated by the researchers (12).
Assessing eye movements and visual acuity:
Eye movements: They were asked to make eye movements in all directions.
Smooth pursuit eye movements:
The patient was asked to watch the index finger of the examiner slowly moving up or down, left or right, with their eye. The patient must be able to see the index finger clearly, the finger should not move more than 60 degrees from one side to the other, and the speed should not be more than 40 degrees per second.
Saccadic eye movements:
The patient was asked to look at the fingers separated from each other by vertical and horizontal planes at a distance of 30 cm. During this time, attention was paid to latency, speed, accuracy and parallelism (conjugation) in the movement of the eyes.
Visual Acuity:
Assessed using a Snellen Chart.
Somatosensorial assessment:
Lower extremity muscle strength Lower extremity muscle strength was assessed with Chair Stand Test. This test was performed by Jones et al. and has been shown to be a valid and reliable measure of the proximal muscle strength of the lower extremities in elderly individuals. In the starting position the person is sitting on a chair without armrests and with their back upright, their arms crossed in front of their chest and their feet on the floor. With the start command, the person does a full standing position and is seated again, the total number of full stands in 30 seconds constitutes their score (13).
Lower extremity sense:
On the lower extremity sensory examination, the light touch sensation was assessed by cotton, the pain sensation by a needle, and the deep sensation by the sensation of the thumb position.
Cerebellar Assessment:
Finger - Nose Test The patient touches their nose with their index finger after touching the index finger of the doctor sitting opposite them. While repeating this movement in succession, the physician changes the position of his finger every time. The results were scored as successful / unsuccessful.
Knee - Heel Test It is examined with the patient laying on their back. After the patient touches their knee with their heel, they lower the foot down on a straight line along the tibia bone. After repeating this movement several times, they do the same with the other foot. The results were scored as successful / unsuccessful.
Alternating Movement Tests The patient is made to do quick alternating movements. The patient opens a hand with the palm up. The back of the other hand and the palmar face touch the open palm with rapid repetitive pronation-supination movements. The results were scored as successful / unsuccessful.
Pulse:
Blood pressure:
Orthostatic hypotension:
Postural blood pressure measurement; the first blood pressure was measured after they had been laying on their back for at least five minutes, the second blood pressure was measured as soon as they stood up and third blood pressure was measured after standing on their feet and waiting for three minutes with a manometer. A fall of 20mmHg relative to the lying position in the systolic blood pressure after standing on their feet and after standing for three minutes was considered significant for orthostatic hypotension (14).
Vit D Level:
Calculation of Sample Size:
The sample size was calculated as the minimum number of subjects required for each of the arms so that a difference of 3.73 units between the two group averages in the Berg Balance Scale (Type 1 error: 0,05, Type 2 error: 0,20) could be significant according to the results of the previous study. The number of subjects in each group will be a minimum of 16(15).
Randomisation and treatment:
Patients who meet the inclusion criteria after initial screening and do not have exclusion criteria will be divided into two groups by layered block randomization and 2 different treatment protocols will be applied. Patients were planned to be included so that at least 16 patients would be in each group.
Group 1: Supervised vestibular rehabilitation program in clinical setting. Group 2: Supervised vestibular rehabilitation program supported with virtual reality
For both groups; 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.
Patients who do not attend at least 3 sessions in the same week will be dropped from the study.
Patients in Group 2 will perform the exercises in a 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. 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.
During the exercises, assisted ambulation system (Biodex Free Step SAS) will be used to ensure the safety of the patient and to prevent falls.
All patients will be trained initially by a physician for 30 minutes, including a definition of fall, definition of prevention, risk factors, information on prevention, and recommendations for preventing falls.
Vestibular Rehabilitation Program
2 sets of 15 minutes; each set will include the following exercises for a total of a 35 minute program.
Exercises for Eye Movements
Smooth- Pursuit Eye Movements:
The patient is asked to move their eyes at first slowly and then quickly in horizontal and vertical directions (10 times). In the 1st week while sitting, in the 2nd week while standing and in the 3rd week while standing on a soft ground.
Saccadic eye movements:
The patient is asked to focus by moving their eyes 1 time per second to 2 targets 30 cm away from each other (10 times). Motion is applied in horizontal and vertical directions. While sitting on the 1st week, standing on the 2nd week, and standing on soft ground for the 3rd week.
Exercises for Gaze Stability
Training of Vestibulo-ocular reflex:
- The patient is asked to move their head first in horizontal, then in vertical directions for 1 minute, focusing on a fixed object. While sitting on the 1st week, standing on the 2nd week, and standing on soft ground for the 3rd week.
- The patient is asked to move their head first in horizontal, then in vertical directions for 1 minute, focusing on a moving object. While sitting on the 1st week, standing on the 2nd week, and standing on soft ground for the 3rd week.
Training of Cervico-ocular reflex The patient sitting on a rotating chair is asked to move their torso to the right and left, keeping his head steady by focusing on a fixed object (10 times). It is conducted in the 1st and 2nd weeks.
Exercises for Postural Stability
Standing up:
- Week: Bend forward and side to side while sitting, pass from sitting position to standing position and back to sitting position (10 times), standing in various positions (feet together, tandem position) (15 sec), marching in place (10 times) is requested.
- Week: Bending their body front and back, and to their sides (10 front and back, 10 to the sides) while standing, standing in various positions (feet together, tandem position) (15 sec), marching in place (10 times) is requested.
- Week The exercises in the 2nd week is conducted on soft ground.
Walking:
Patients conduct their exercises while walking at a pace of 1.6km/h on the treadmill.
- Week: They are asked to walk forward on the treadmill (1 min)
- Week: They are asked to walk on the treadmill while moving their head left-right, front-back (1 min)
- Week:
They are asked to walk on the treadmill while focusing on a fixed object and moving their heads first horizontally and then vertically (1 min)
Assessment Parameters
Dizziness Assessment
Vertigo Symptom Scale (Short form):
It 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. Each item is scored between 0-4 and the scores of all items are summed to obtain the symptom severity score. The total score is between 0 and 60, higher scores indicate a more serious problem. A total score of 12 or more indicates severe dizziness. The scale consists of 8 items related to vertigo-balance, scored between 0-32 points (VSS-V), and 7 items related to autonomic-anxiety symptoms and 2 scales scored between 0-28 points (VSS-A) (16,17). The validity and reliability studies of the Turkish version were made by Yanık et al. (18).
Dizziness Disability Inventory:
The Dizziness Disability Inventory (DDI), 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. There are nine items each that determine the emotional state and functional status and seven items that determine the physical function. If the answers to the questions are "yes", they are scored as four points, "sometimes" as two points, and "no" as zero points. The maximum score for the emotional and functional subgroups is 36, and for the physical function subgroup the maximum score is 28, with a maximum score of 100 in total. The minimum score for all subgroups and total score is zero. High score indicates more disability (19). The validity and reliability studies of the Turkish version were made by Ellialtıoğlu and their colleagues (20).
Balance Assessment
Berg Balance Test:
The Berg balance test (BBT), which was developed by Berg et al. in 1989 and proved to be valid and reliable in 1992, was used as a clinical balance test. This 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. In BBT, the level of qualification for each item is scored from zero to four, where 0 means "can not do it"; and 4 means "can do it independently and safely". The total maximum score is 56 and the higher scores show a better balance (21). Şahin et al. showed that the Turkish version of the Berg balance test was a reliable and valid scale for assessing balance in elderly adults (22).
Dynamic Posturography Biodex Balance System (Biodex, Inc., Shirley, New York) was used to evaluate the dynamic balance in elderly subjects (23,24). Postural stability tests and the risk of falls (General Stability Index, Medio-lateral Stability Index, Antero-posterior Stability Index, Falling Risks Index) were calculated. There is a balance platform of this system in relation to a computer software that allows moving, balanced, objective evaluation of the system, which can be tilted up to 20 ° at a 360 ° range of motion. The overall stability score refers to the balance ability of the person in general and high values indicate that the balance is bad. Patients are tested on the platform at the 8th level, with the eyes open and on both feet, while the feet are naked and the person is in the most comfortable position where they can keep their balance, their knees are at the slightest flexion (15º). After a 20-second trial test, each person was subjected to three 20-second tests. A 10-second rest period was provided between each test, and as a result, averages of these three tests were obtained.
Functional Mobility Assessment
TUG:
Timed Up\&Go (TUG) test was used to assess functional mobility. In this test the elapsed time is measured in seconds for the individual to get up from the sitting position, walk a three meter distance and return. During the test, the standard chair with armrests should have a tape, cone or other clear marker indicating the end of the distance and the person should be wearing walking shoes they are used to and if they use a supportive device such as a walker or crutches, this should be noted and also used during the test (25).
Assessment of fear of falling:
International Falls Efficacy Scale:
The test described by Yardley et al. in 2005 consists of 16 questions that assess patients' anxiety about the possibility of falls during their daily activities. Each question is scored between 0-4 in itself (26). The validity and reliability study in Turkish for the elderly population was conducted (27).
Anxiety/Depression Assessment Geriatric Depression Scale To assess depression, we used Geriatric Depression Scale (GDS) developed by Yesavage and colleagues to screen for depression in the elderly population. The 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. The high scores indicate depressive characteristics. The total score is thirty, with the scores meaning no depression between 0-11, possible depression between 11-14, and definite depression for 14 and over (28). The validity and reliability of the GDS has been proven by translating it into Turkish by Ertan and his colleagues (29).
Hamilton Anxiety Assessment Scale:
This scale, developed by Hamilton, questions the anxiety severity, psychological and somatic symptoms. In the 14 questions, topics such as anxious temperament, tension, fear, insomnia, intellectual status, depressive temperament, body symptoms, somatic symptoms, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms and behaviours during the interview are questioned. When each of the 14 items are assessed, a score of 0-4 is given (0=none, 1=mild, 2=medium, 3=severe, 4=very severe) and the patients are evaluated based on the scores they receive in the overall total. The higher the score, the higher the severity of anxiety. The total score is between 0-56, below 17 is mild, between 18-24 is moderate and 25-30 is severe (30). Reliability and validity studies in Turkey were made by Yazıcı and his colleagues (31).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation | Active comparator | Other: Vestibular Rehabilitation supported with Virtual RealityVestibular 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. |
| Vestibular Rehabilitation supported with Virtual Reality | Experimental | Other: Vestibular Rehabilitation supported with Virtual RealityPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation supported with Virtual RealityPatients 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. | Other | Vestibular Rehabilitation, Vestibular Rehabilitation supported with Virtual Reality |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Timed Up&Go (TUG) test
Time frame: 3 weeks
International Falls Efficacy Scale
Time frame: 3 weeks
Geriatric Depression Scale
Time frame: 3 weeks
Hamilton Anxiety Assessment Scale
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 26167157Fernandez L, Breinbauer HA, Delano PH. Vertigo and Dizziness in the Elderly. Front Neurol. 2015 Jun 26;6:144. doi: 10.3389/fneur.2015.00144. eCollection 2015.
- Background: PubMed 12616402Salles N, Kressig RW, Michel JP. Management of chronic dizziness in elderly people. Z Gerontol Geriatr. 2003 Feb;36(1):10-5. doi: 10.1007/s00391-003-0141-x.
- Background: PubMed 23177607Lo AX, Harada CN. Geriatric dizziness: evolving diagnostic and therapeutic approaches for the emergency department. Clin Geriatr Med. 2013 Feb;29(1):181-204. doi: 10.1016/j.cger.2012.10.004.
- Background: PubMed 21979272Yang XJ, Hill K, Moore K, Williams S, Dowson L, Borschmann K, Simpson JA, Dharmage SC. Effectiveness of a targeted exercise intervention in reversing older people's mild balance dysfunction: a randomized controlled trial. Phys Ther. 2012 Jan;92(1):24-37. doi: 10.2522/ptj.20100289. Epub 2011 Oct 6.
- Background: PubMed 19720245Jung JY, Kim JS, Chung PS, Woo SH, Rhee CK. Effect of vestibular rehabilitation on dizziness in the elderly. Am J Otolaryngol. 2009 Sep-Oct;30(5):295-9. doi: 10.1016/j.amjoto.2008.06.013. Epub 2009 Feb 6.
- Background: PubMed 23467506Duque G, Boersma D, Loza-Diaz G, Hassan S, Suarez H, Geisinger D, Suriyaarachchi P, Sharma A, Demontiero O. Effects of balance training using a virtual-reality system in older fallers. Clin Interv Aging. 2013;8:257-63. doi: 10.2147/CIA.S41453. Epub 2013 Feb 28.
- Background: PubMed 22324055Toulotte C, Toursel C, Olivier N. Wii Fit(R) training vs. Adapted Physical Activities: which one is the most appropriate to improve the balance of independent senior subjects? A randomized controlled study. Clin Rehabil. 2012 Sep;26(9):827-35. doi: 10.1177/0269215511434996. Epub 2012 Feb 9.
- Background: PubMed 23241332Pichierri G, Murer K, de Bruin ED. A cognitive-motor intervention using a dance video game to enhance foot placement accuracy and gait under dual task conditions in older adults: a randomized controlled trial. BMC Geriatr. 2012 Dec 14;12:74. doi: 10.1186/1471-2318-12-74.
- Background: PubMed 22409245Laver K, George S, Ratcliffe J, Quinn S, Whitehead C, Davies O, Crotty M. Use of an interactive video gaming program compared with conventional physiotherapy for hospitalised older adults: a feasibility trial. Disabil Rehabil. 2012;34(21):1802-8. doi: 10.3109/09638288.2012.662570. Epub 2012 Mar 12.
- Background: PubMed 21799138Szturm T, Betker AL, Moussavi Z, Desai A, Goodman V. Effects of an interactive computer game exercise regimen on balance impairment in frail community-dwelling older adults: a randomized controlled trial. Phys Ther. 2011 Oct;91(10):1449-62. doi: 10.2522/ptj.20090205. Epub 2011 Jul 28.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 19337986Keskinoglu P, Ucku R, Yener G, Yaka E, Kurt P, Tunca Z. Reliability and validity of revised Turkish version of Mini Mental State Examination (rMMSE-T) in community-dwelling educated and uneducated elderly. Int J Geriatr Psychiatry. 2009 Nov;24(11):1242-50. doi: 10.1002/gps.2252.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation supported with Virtual Reality in people with Dizziness and Vestibular Rehabilitation, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertigo Symptom Scale (Short form) (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412708, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.