Vestibular DiseaseNCT02867683
Vibrotactile Feedback During Vestibular Therapy
A study testing Vibrotactile Feedback in people with Vestibular Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disease
- What is being tested?
- Vibrotactile Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 31 Jan 2018
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral peripheral vestibular hypofunction
- bilateral peripheral vestibular hypofunction
Who cannot join
- confounding neurologic or neuromuscular disorders
- pregnancy
- inability to stand for 3 minutes
- recent lower extremity fracture/severe sprain within the last 6 months
- previous lower extremity joint replacement
- incapacitating back or lower extremity pain
- body too large for equipment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
About this study
Official title: The Effects of Vibrotactile Feedback During Vestibular Rehabilitation
This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback.
Read the detailed description
Vestibular and balance rehabilitation is an effective way to improve balance for individuals with balance impairments by using the strategies of adaptation, habituation, or substitution. Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with uncompensated unilateral vestibular hypofunction or bilateral vestibular loss, recovery/adaptation is often incomplete and chronic balance impairments result.
Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace disrupted or absent vestibular function. The sensory information replaces disrupted or absent vestibular function to give persons additional signals about their body position in space. Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term benefits of training with VTF on balance and function have not been examined.
- Conditions
- Vestibular Disease
- Being tested
- Vibrotactile Feedback
- Keywords
- vibrotactile feedback, vestibular rehabilitation, balance
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile FeedbackOther
Balance training Vibrotactile feedback applied to the trunk
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Feedback | Experimental | Balance exercises completed while vibration was applied to the trunk (anterior, posterior, right, and left) if postural sway exceeded a pre-determined threshold during the exercise. Receives: Other: Vibrotactile Feedback |
| Without Vibrotactile Feedback | No intervention | Balance training without feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sensory Organization Testing
Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in 10-meter walk test
Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Dynamic Gait Index and Functional Gait Assessment
Measures that assess ability to modify walking in the presence of external demands. Includes tasks such walking with head turns, walking around obstacles, stepping over obstacles, and negotiating stairs. Each task is scored on a 4 point scale (0-3) and a total score is compiled.
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Five Times Sit to Stand
A stopwatch is used to record the amount of time it takes the participant to move from a seated position to a standing position back to seated without using their hads for a total of 5 repetitions
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Secondary outcomes (3)
Change in Activities-specific Balance Confidence Scale
A 16-item self-report instrument which the participants completes by scoring their perceived confidence level during activities of daily living.
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Dizziness Handicap Inventory
A self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness.
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Short Form-12
A 12 question self-report instrument that provide information about mental and physical functioning as well as health-related quality of life
Measured: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2013
- Primary completion1 Aug 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Susan Whitney, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867683
- Sponsor's protocol ID
- PRO13020399
- Other IDs
- 5R21DC012410
- Status last verified
- Feb 2018
- First submitted
- 4 Aug 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vibrotactile Feedback During Vestibular Rehabilitation
- ClinicalTrials.gov ID
- NCT02867683
- Acronym / sponsor ID
- PRO13020399
- Conditions
- Vestibular Disease
- Keywords
- vibrotactile feedback, vestibular rehabilitation, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Oct 2013
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 16 Aug 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.
This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback.
Detailed description
Vestibular and balance rehabilitation is an effective way to improve balance for individuals with balance impairments by using the strategies of adaptation, habituation, or substitution. Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with uncompensated unilateral vestibular hypofunction or bilateral vestibular loss, recovery/adaptation is often incomplete and chronic balance impairments result.
Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace disrupted or absent vestibular function. The sensory information replaces disrupted or absent vestibular function to give persons additional signals about their body position in space. Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term benefits of training with VTF on balance and function have not been examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Feedback | Experimental | Other: Vibrotactile FeedbackBalance exercises completed while vibration was applied to the trunk (anterior, posterior, right, and left) if postural sway exceeded a pre-determined threshold during the exercise. |
| Without Vibrotactile Feedback | No intervention | –Balance training without feedback |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral peripheral vestibular hypofunction
- bilateral peripheral vestibular hypofunction
Key exclusion criteria (7 listed)
- confounding neurologic or neuromuscular disorders
- pregnancy
- inability to stand for 3 minutes
- recent lower extremity fracture/severe sprain within the last 6 months
- previous lower extremity joint replacement
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 |
|---|---|---|
| Vibrotactile FeedbackBalance training Vibrotactile feedback applied to the trunk | Other | Vibrotactile Feedback |
Primary outcome
Change in Sensory Organization Testing
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Postural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
Change in 10-meter walk test
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Participants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
Change in Dynamic Gait Index and Functional Gait Assessment
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Measures that assess ability to modify walking in the presence of external demands. Includes tasks such walking with head turns, walking around obstacles, stepping over obstacles, and negotiating stairs. Each task is scored on a 4 point scale (0-3) and a total score is compiled.
Change in Five Times Sit to Stand
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
A stopwatch is used to record the amount of time it takes the participant to move from a seated position to a standing position back to seated without using their hads for a total of 5 repetitions
3 secondary outcomes
Change in Activities-specific Balance Confidence Scale
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Dizziness Handicap Inventory
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Change in Short Form-12
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Feedback in people with Vestibular Disease, run by University of Pittsburgh at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Sensory Organization Testing (time frame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks). The study lists 4 primary outcomes in all. 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 6 Feb 2018.