Activity Treatment on Vestibular Rehabilitation

August 7, 2020 updated by: Bilgehan Tekin Dal

Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders

In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.

Study Overview

Detailed Description

The aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. Patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. Education was given to each group. İn addition, the activity group was performed a training activities program, the exercise group was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed once daily at home for 4 weeks. After demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was assessed by Sensory Organization Testing (SOT).

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06010
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients have dizziness complaint longer than 3 months,
  • History of at least one dizziness in a month
  • Patient has been diagnosed chronic unilateral peripheric vestibular disorder

Exclusion Criteria:

  • Patients with diagnosed benign paroxysmal positional vertigo, had Meniere's disease, had history of central nerve system impairments and/or psychiatric disorder, had uncontrolled hypertension and diabetes, had not understanding simple verbal instruction and following ability, not able to stand independent in the standstill position, had visual problems that cannot be treated with lenses or glasses, had movement limitation due to the orthopedic problem, using medication for dizziness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
No intervention
ACTIVE_COMPARATOR: activity group
Participants received an activity-based home program that was performed for 4 weeks.
Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.
Other Names:
  • purposeful activities
EXPERIMENTAL: exercise group
Participants received an exercise-based home program was performed that was performed for 4 weeks.
Cawthorne-cooksey exercises were performed at vestibular rehabilitation
Other Names:
  • Cawthorne-cooksey exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).
Time Frame: before and after treatment (4 weeks)
VAS is a self-reported instrument assessing the severity of diziness.
before and after treatment (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).
Time Frame: before and after treatment (4 weeks)
VADL is a questionnaire assessing the Independent level of activity in daily life.
before and after treatment (4 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from before and after treatment in the postural stability on Computerized Dynamic Posturography (CDP).
Time Frame: before and after treatment (4 weeks)
Computerized dynamic posturography (CDP) testing is a technique used to assess underlying sensory and motor control impairments associated with balance disorders.
before and after treatment (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

November 19, 2019

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 5057087198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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