Back to resultsFunction Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
Primary Purpose
Vertigo
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Traditional vestibular rehabilitation
Cognitive and vestibular dual task training
Sponsored by
About this trial
This is an interventional treatment trial for Vertigo
Eligibility Criteria
Inclusion Criteria:
Older than 60 years old
It meets the diagnostic criteria of vertigo disease
Agree to participate in the experiment
Exclusion Criteria:
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
Sites / Locations
- The First Affiliated Hospital of Air Force Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional vestibular rehabilitation
Cognitive and vestibular dual task training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05103748
Brief Title
Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
Official Title
Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional vestibular rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cognitive and vestibular dual task training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional vestibular rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and vestibular dual task training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short physical performance battery scale
Description
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.
Time Frame
8 weeks
Title
Berg balance scale
Description
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.
Time Frame
8 weeks
Title
Dynamic Gait Index scale
Description
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.
Time Frame
8 weeks
Title
Montreal Cognitive Assessment Scale
Description
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.
Time Frame
8 weeks
Title
Dizziness handicap inventory scale
Description
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).
Time Frame
8 weeks
Title
Visual analogue scale
Description
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).
Time Frame
8 weeks
Title
Generalized Anxiexy Disorde-7 scale
Description
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.
Time Frame
8 weeks
Title
Morse Fall scale
Description
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.
Time Frame
8 weeks
Title
Frail scale
Description
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.
Time Frame
8 weeks
Title
Mini-mental State Examination
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dataset of functional magnetic resonance imaging on brain
Description
Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Older than 60 years old
It meets the diagnostic criteria of vertigo disease
Agree to participate in the experiment
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Fu
Phone
18292880760
Email
fweifmmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Wang
Organizational Affiliation
Department of Geriatrics, Xijing Hospital, Air Force Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Fu, Dr
Phone
18292880760
Email
fweifmmu@163.com
12. IPD Sharing Statement
Learn more about this trial
Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods
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