Vestibular DisorderNCT02746770
Physiotherapy in Vestibular Disorders
A study testing Experimental: Cawthorne and Cooksey exercises group in people with Vestibular Disorder, run by University of Jaén.
Trial summary
Spanish population with unilateral peripheral vestibular disorders. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Experimental: Cawthorne and Cooksey exercises group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with with unilateral peripheral vestibular disorders
Who cannot join
- Bilateral vestibular disorders
- Fluctuating or active unilateral vestibular disease
- Or other medical conditions in the acute phase were excluded from the study.
About this study
Spanish population with unilateral peripheral vestibular disorders.
Read the 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.
- Conditions
- Vestibular Disorder
- Being tested
- Experimental: Cawthorne and Cooksey exercises group
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Cawthorne and Cooksey exercises groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cawthorne and Cooksey exercises group | Experimental | 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. Receives: Other: Experimental: Cawthorne and Cooksey exercises group |
| control group | No intervention | intervention: The control group will not perform the active exercise that will be applied to intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities-specific Balance Confidence scale (ABC)
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.
Measured: Baseline and after 6 weeks of intervention
Secondary outcomes (2)
UCLA Dizziness Questionnaire (UCLA-DQ)
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.
Measured: Baseline and after 6 weeks of intervention
Dizziness Handicap Inventory (DHI),
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.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746770
- Sponsor's protocol ID
- vestibularuja
- Status last verified
- Apr 2016
- First submitted
- 25 Feb 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy in Vestibular Disorders
- ClinicalTrials.gov ID
- NCT02746770
- Acronym / sponsor ID
- vestibularuja
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spanish population with unilateral peripheral vestibular disorders.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cawthorne and Cooksey exercises group | Experimental | Other: Experimental: Cawthorne and Cooksey exercises groupIntervention: 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. |
| control group | No intervention | –intervention: The control group will not perform the active exercise that will be applied to intervention group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with with unilateral peripheral vestibular disorders
Key exclusion criteria (3 listed)
- Bilateral vestibular disorders
- Fluctuating or active unilateral vestibular disease
- Or other medical conditions in the acute phase were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Cawthorne and Cooksey exercises groupExperimental: intervention group. Patients assigned to the experimental group will perform the Cawthorne and Cooksey exercises for vestibular rehabilitation in addition to their habitual treatment. | Other | Cawthorne and Cooksey exercises group |
Primary outcome
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.
2 secondary outcomes
UCLA Dizziness Questionnaire (UCLA-DQ)
Time frame: Baseline and after 6 weeks of intervention
Dizziness Handicap Inventory (DHI),
Time frame: Baseline and after 6 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Cawthorne and Cooksey exercises group in people with Vestibular Disorder, run by University of Jaén.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities-specific Balance Confidence scale (ABC) (time frame: Baseline and after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.