- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746770
Physiotherapy in Vestibular Disorders
April 20, 2016 updated by: DAVID CRUZ DÍAZ, University of Jaen
Spanish population with unilateral peripheral vestibular disorders.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Participants with peripheral vestibular disorders will be allocated to a Cawthorne and Cooksey exercises protocol or control group.
The Cawthorne and Cooksey exercises consist in some head mobilization and positioning tasks which are related with a restoration of vestibular disorders.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with with unilateral peripheral vestibular disorders
Exclusion Criteria:
- Bilateral vestibular disorders
- Fluctuating or active unilateral vestibular disease
- Or other medical conditions in the acute phase were excluded from the study.
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cawthorne and Cooksey exercises group
Intervention: Participants allocated in both control and experimental groups were receiving treatment for their specific vestibular disorders.
Patients assigned to the experimental group also performed the Cawthorne and Cooksey exercises for vestibular rehabilitation during a six week of treatment period.
|
Experimental: intervention group.
Patients assigned to the experimental group will perform the Cawthorne and Cooksey exercises for vestibular rehabilitation in addition to their habitual treatment.
|
No Intervention: control group
intervention: The control group will not perform the active exercise that will be applied to intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities-specific Balance Confidence scale (ABC)
Time Frame: Baseline and after 6 weeks of intervention
|
Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady.
This scale is applied to assess the change due to intervention between the baseline and 6 weeks of treatment.
So the data will be collected at baseline and after 6 weeks of treatment.
|
Baseline and after 6 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UCLA Dizziness Questionnaire (UCLA-DQ)
Time Frame: Baseline and after 6 weeks of intervention
|
UCLA Dizziness Questionnaire (UCLA-DQ), used to measure the severity and frequency of dizziness and its impact on quality of life.
This questionnaire is applied to assess the change due to intervention between the baseline and 6 weeks of treatment.
So the data will be collected at baseline and after 6 weeks of treatment.
|
Baseline and after 6 weeks of intervention
|
Dizziness Handicap Inventory (DHI),
Time Frame: Baseline and after 6 weeks of intervention
|
Dizziness Handicap Inventory (DHI), to assess the level of disability and handicap.This questionnaire is applied to assess the change due to intervention between the baseline and 6 weeks of treatment.
So the data will be collected at baseline and after 6 weeks of treatment.
|
Baseline and after 6 weeks of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2016
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
February 25, 2016
First Submitted That Met QC Criteria
April 20, 2016
First Posted (Estimate)
April 21, 2016
Study Record Updates
Last Update Posted (Estimate)
April 21, 2016
Last Update Submitted That Met QC Criteria
April 20, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vestibularuja
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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