VertigoNCT05103748
Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
A study testing Traditional vestibular rehabilitation and Cognitive and vestibular dual task training in people with Vertigo, run by Xijing Hospital at 1 site in China.
Trial summary
By evaluating the balance, gait and cognitive functions of the elderly patients with vertigo, the relevant functional disorders of the elderly patients with vertigo were clarified, and the functional disorders of the elderly patients with vertigo were improved through the new rehabilitation intervention. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertigo
- What is being tested?
- Traditional vestibular rehabilitation and Cognitive and vestibular dual task training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 60 years old
- It meets the diagnostic criteria of vertigo disease
- Agree to participate in the experiment
Who cannot join
- Complete paralysis caused by severe cerebrovascular diseases
- Patients with disability and dementia and long-term bedridden
- Unwilling to cooperate with the visitors
- Patients who did not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032
Wei Fu, Dr, 18292880760, fweifmmu@163.com
About this study
By evaluating the balance, gait and cognitive functions of the elderly patients with vertigo, the relevant functional disorders of the elderly patients with vertigo were clarified, and the functional disorders of the elderly patients with vertigo were improved through the new rehabilitation intervention.
- Conditions
- Vertigo
- Being tested
- Traditional vestibular rehabilitation, Cognitive and vestibular dual task training
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional vestibular rehabilitationBehavioural
The patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target.
Cognitive and vestibular dual task trainingBehavioural
The patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. Besides, patients wear headphones to listen to the numbers at the same time. The numbers contain 1 and 2, and they are played randomly. They shake their heads when they hear 1, and nod when they hear 2. The training takes 30 minutes, once a day in the morning and evening.
| Study group | Role | What they receive |
|---|---|---|
| Traditional vestibular rehabilitation | Active comparator | The patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. Receives: Behavioral: Traditional vestibular rehabilitation |
| Cognitive and vestibular dual task training | Experimental | The patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. Besides, patients wear headphones to listen to the numbers at the same time. The numbers contain 1 and 2, and they are played randomly. They shake their heads when they hear 1, and nod when they hear 2. The training takes 30 minutes, once a day in the morning and evening. Receives: Behavioral: Cognitive and vestibular dual task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short physical performance battery scale
Each of the three subtests (balance, walking speed and repeated chair sit-to-stand test) of the short physical performance battery scale was scored from 0 to 4. The minimum test score is 0 point and maximum test score is 12 points. Higher scores indicate better physical performance.
Measured: 8 weeks
Berg balance scale
The berg balance scaleis composed of 14 items that assess an individual's performance on specific functional tasks. Each item is scored from 0 to 4. The minimum test score is 0 point and maximum test score is 56 points. Higher scores indicate better balance performance.
Measured: 8 weeks
Dynamic Gait Index scale
Dynamic Gait Index scale consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over obstacle, gait around obstacles and steps up and down stairs. The performance on each item is rated on a 4-point scale (3, independent walking; 2, mild impairment; 1, moderate impairment; 0, severe disorder). The minimum test score is 0 point and maximum test score is 24 points. Higher scores indicate better gait performance.
Measured: 8 weeks
Montreal Cognitive Assessment Scale
The Montreal Cognitive Assessment Scale includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; < 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.
Measured: 8 weeks
Dizziness handicap inventory scale
The dizziness handicap inventory consists of 25 items divided into 3 domains believed to encompass the impact of the disease: functional (9 questions), emotional (9 questions), and physical (7 questions). Each item is assigned 0, 2, or 4 points; therefore, the dizziness handicap inventory total scores is between 0 and 100 points. Mild dizziness(dizziness handicap inventory scale score ≤30) and moderate to severe dizziness(dizziness handicap inventory scale score >30).
Measured: 8 weeks
Visual analogue scale
The visual analogue scale for dizziness used a straight line of 10 cm in length. The numbers between 0 and 10 were marked at equal intervals along the line. The participants were asked to report their self-perceived dizziness on a visual analogue scale describing the severity of dizziness in everyday life on a continuum from 0 (none dizziness) to 10 (extremely severe dizziness).
Measured: 8 weeks
Generalized Anxiexy Disorde-7 scale
The presence of perceived anxiety was evaluated with the Generalized Anxiety Disorder 7-item scale. A score of≤9 points indicates no or mild anxiety; >9, moderate to severe anxiety.
Measured: 8 weeks
Morse Fall scale
There are six main variables measured by the Morse Fall scale: (1) history of falling (possible score of 0 or 25); (2) secondary diagnosis (0 or 15); (3) ambulatory aid (0, 15, or 30); (4) IV or IV access (0 or 20); (5) gait (0, 10, 20); and (6) mental status (0 or 15). The total score can range from 0-125. The scale developers recommend a cut-off point of 45; though, calibration of the scores for patient symptoms and healthcare setting is advised. In this study setting, Morse Fall scale scores of 0-24 were classified as no risk, 25-50 as low risk and 51-125 as high risk.
Measured: 8 weeks
Frail scale
Frailty was assessed using the frail scale. There are 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. The presence of each characteristic was scored with 1 point and the absence of each characteristic was scored with 0 point. The frail score ranges from 0 to 5, where a score of 0 represents robust, 1-2 as pre-frail, and 3-5 as frail.
Measured: 8 weeks
Mini-mental State Examination
Mini-mental State Examination includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and < 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.
Measured: 8 weeks
Secondary outcomes (1)
Dataset of functional magnetic resonance imaging on brain
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jul 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoming Wang, Study director, Department of Geriatrics, Xijing Hospital, Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103748
- Sponsor's protocol ID
- KY20212067-F-1
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
- ClinicalTrials.gov ID
- NCT05103748
- Acronym / sponsor ID
- KY20212067-F-1
- Conditions
- Vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Nov 2021 (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.
By evaluating the balance, gait and cognitive functions of the elderly patients with vertigo, the relevant functional disorders of the elderly patients with vertigo were clarified, and the functional disorders of the elderly patients with vertigo were improved through the new rehabilitation intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional vestibular rehabilitation | Active comparator | Behavioral: Traditional vestibular rehabilitationThe patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. |
| Cognitive and vestibular dual task training | Experimental | Behavioral: Cognitive and vestibular dual task trainingThe patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. Besides, patients wear headphones to listen to the numbers at the same time. The numbers contain 1 and 2, and they are played randomly. They shake their heads when they hear 1, and nod when they hear 2. The training takes 30 minutes, once a day in the morning and evening. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 60 years old
- It meets the diagnostic criteria of vertigo disease
- Agree to participate in the experiment
Key exclusion criteria (4 listed)
- Complete paralysis caused by severe cerebrovascular diseases
- Patients with disability and dementia and long-term bedridden
- Unwilling to cooperate with the visitors
- Patients who did not meet the inclusion criteria
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 |
|---|---|---|
| Traditional vestibular rehabilitationThe patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. | Behavioural | Traditional vestibular rehabilitation |
| Cognitive and vestibular dual task trainingThe patient shook his head horizontally and looked in the direction of head rotation. Repeated 10 times, and then shook his head with eyes closed and repeated 10 times. The patient holds a small visual target to practice. The small visual target is placed about 30cm in front of the patient. The subject moves his head back and forth while keeping his sight on the target. Besides, patients wear headphones to listen to the numbers at the same time. The numbers contain 1 and 2, and they are played randomly. They shake their heads when they hear 1, and nod when they hear 2. The training takes 30 minutes, once a day in the morning and evening. | Behavioural | Cognitive and vestibular dual task training |
Primary outcome
Short physical performance battery scale
Time frame: 8 weeks
Each of the three subtests (balance, walking speed and repeated chair sit-to-stand test) of the short physical performance battery scale was scored from 0 to 4. The minimum test score is 0 point and maximum test score is 12 points. Higher scores indicate better physical performance.
Berg balance scale
Time frame: 8 weeks
The berg balance scaleis composed of 14 items that assess an individual's performance on specific functional tasks. Each item is scored from 0 to 4. The minimum test score is 0 point and maximum test score is 56 points. Higher scores indicate better balance performance.
Dynamic Gait Index scale
Time frame: 8 weeks
Dynamic Gait Index scale consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over obstacle, gait around obstacles and steps up and down stairs. The performance on each item is rated on a 4-point scale (3, independent walking; 2, mild impairment; 1, moderate impairment; 0, severe disorder). The minimum test score is 0 point and maximum test score is 24 points. Higher scores indicate better gait performance.
Montreal Cognitive Assessment Scale
Time frame: 8 weeks
The Montreal Cognitive Assessment Scale includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; < 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.
Dizziness handicap inventory scale
Time frame: 8 weeks
The dizziness handicap inventory consists of 25 items divided into 3 domains believed to encompass the impact of the disease: functional (9 questions), emotional (9 questions), and physical (7 questions). Each item is assigned 0, 2, or 4 points; therefore, the dizziness handicap inventory total scores is between 0 and 100 points. Mild dizziness(dizziness handicap inventory scale score ≤30) and moderate to severe dizziness(dizziness handicap inventory scale score >30).
Visual analogue scale
Time frame: 8 weeks
The visual analogue scale for dizziness used a straight line of 10 cm in length. The numbers between 0 and 10 were marked at equal intervals along the line. The participants were asked to report their self-perceived dizziness on a visual analogue scale describing the severity of dizziness in everyday life on a continuum from 0 (none dizziness) to 10 (extremely severe dizziness).
Generalized Anxiexy Disorde-7 scale
Time frame: 8 weeks
The presence of perceived anxiety was evaluated with the Generalized Anxiety Disorder 7-item scale. A score of≤9 points indicates no or mild anxiety; >9, moderate to severe anxiety.
Morse Fall scale
Time frame: 8 weeks
There are six main variables measured by the Morse Fall scale: (1) history of falling (possible score of 0 or 25); (2) secondary diagnosis (0 or 15); (3) ambulatory aid (0, 15, or 30); (4) IV or IV access (0 or 20); (5) gait (0, 10, 20); and (6) mental status (0 or 15). The total score can range from 0-125. The scale developers recommend a cut-off point of 45; though, calibration of the scores for patient symptoms and healthcare setting is advised. In this study setting, Morse Fall scale scores of 0-24 were classified as no risk, 25-50 as low risk and 51-125 as high risk.
Frail scale
Time frame: 8 weeks
Frailty was assessed using the frail scale. There are 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. The presence of each characteristic was scored with 1 point and the absence of each characteristic was scored with 0 point. The frail score ranges from 0 to 5, where a score of 0 represents robust, 1-2 as pre-frail, and 3-5 as frail.
Mini-mental State Examination
Time frame: 8 weeks
Mini-mental State Examination includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and < 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.
1 secondary outcome
Dataset of functional magnetic resonance imaging on brain
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
Related trials for Vertigo
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
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.
Xiaoming Wang study director
Department of Geriatrics, Xijing Hospital, Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional vestibular rehabilitation and Cognitive and vestibular dual task training in people with Vertigo, run by Xijing Hospital at 1 site in China.
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 4 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 2 Nov 2021. 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 China. 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?
Contact Wei Fu (18292880760, fweifmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short physical performance battery scale (time frame: 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2021.