Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods

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 Overview

• Status: Recruiting
• Conditions: Vertigo
• Intervention / Treatment: Behavioral: Traditional vestibular rehabilitation; Behavioral: Cognitive and vestibular dual task training

• Study Type: Interventional
• Enrollment (Anticipated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Fu; Phone Number: 18292880760; Email: fweifmmu@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • The First Affiliated Hospital of Air Force Medical University
      • Contact: Wei Fu, Dr; Phone Number: 18292880760; Email: fweifmmu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional vestibular rehabilitation; 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.	Behavioral: Traditional vestibular rehabilitation; 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.
Experimental: Cognitive and vestibular dual task training; 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.	Behavioral: Cognitive and vestibular dual task training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	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).	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.	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.	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.	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Director: Xiaoming Wang, Department of Geriatrics, Xijing Hospital, Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: October 31, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: KY20212067-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No