Whole Body Vibration In Vestibular Rehabilitation

NCT03973255 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the efficacy of home based vestibular rehabilitation program, posturographic biofeedback training and whole body vibration therapy on balance, fall risk, functional mobility, vertigo symptom severity and functions in patients with unilateral vestibular weakness.

Conditions

Vestibular Disease

Keywords

Vestibular rehabilitation; Vestibular weakness; Whole Body Vibration; Biofeedback; Posturography

Outcome Measures

Primary Outcomes (5)

• fall risk

  fall risk yielded by static posturography

  30 days

• Berg balance scale

  BBS consists of 14 tasks that are each scored on a scale of 0-4, for a total possible score of 56, indicating no identified balance difficulties. Scoring is on a 5-point ordinal scale with 0 indicating an inability to complete the task and 4 as independent in completing the task.

  30 days

• Timed Up-and-Go

  TUG is a balance and gait index which requires subjects to rise from an armchair, walk 3 m at a normal and safe pace, turn around, walk back to the chair and sit-down. The time required to complete this task is measured in seconds.

  30 days

• vertigo visual analogue scale

  A vertically oriented 10 cm line was used for VAS, where "no vertigo" corresponds to the bottom of the line and "the worst vertigo that they could imagine" corresponds to the top of the line. Patients were instructed to place a mark on the 10-cm vertical line according to severity of their vertigo.

  30 days

• Dizziness Handicap Inventory

  The DHI has 25 items, sub-grouped into three domains: functional, emotional, and physical. There are three closed-form answers where patients may check one of the following: yes, sometimes and no with the corresponding scored as 4/2/0. It is possible to use both the total score and the scores of the three subscales separately.

  30 days

Study Arms (3)

Home based vestibular rehabilitation program

PLACEBO COMPARATOR

Home-based vestibular rehabilitation program including vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises was given to each group in the form of a booklet. All exercises were demonstrated and performed first time at hospital under supervision. Booklet with descriptions and pictures of each exercise were given to patients in order to enable them to perform exercises at home. Vestibular rehabilitation exercises were prescribed as once daily with 10 repetitions at home for one month and wanted to mark a chart if the exercises were performed daily. A diary was used to monitor adherence with the program.

Behavioral: Rehabilitation

Biofeedback training

ACTIVE COMPARATOR

Biofeedback training was performed five days a week during a month for 20 minutes for a total of 20 sessions with Tetrax ® (Sunlight Medical Ltd) static posture analysis device. Biofeedback training including "catch, speedball, sky ball, gotcha" exercises which requires following a visual target during weight transfer movements, capturing fast-moving objects by changing the center of gravity or quickly escaping from incoming objects, were applied to the patients in biofeedback training. There is a 30 seconds pause between each exercise.

Behavioral: Rehabilitation

Whole body vibration

ACTIVE COMPARATOR

Whole body vibration training was also performed five days a week during a month for 20 minutes for a total of 20 sessions with Power Plate Pro 5 (MDD CE 0086). In whole body vibration, single leg, squat and deep squat positions were applied respectively with 35 Hz frequency, including rest periods of 30 seconds between each application.

Behavioral: Rehabilitation

Interventions

Rehabilitation BEHAVIORAL

Posturography, Whole body vibration

Biofeedback training; Home based vestibular rehabilitation program; Whole body vibration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included Bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness.

You may not qualify if:

• Bilateral vestibular weakness, Recurrent vestibulopathy, Benign paroxysmal positional vertigo, Concomitant neurological or psychiatric disease, Severe visual or auditory impairments and orthopedic problems in the lower extremities

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fazıl N Ardıç, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.Fazıl Necdet Ardıç

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 4, 2019
• Study Start: March 13, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 31, 2019
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)