- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425928
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
Status
Completed
Conditions
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
-
-
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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:
|
|
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
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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