Vestibular DisorderNCT03952936
Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study
A study testing Vestibular Rehabilitation in people with Vestibular Disorder and Fall, run by Methodist University, North Carolina at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder, Fall, Coordination and Balance Disturbances
- What is being tested?
- Vestibular Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Aug 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Central vestibular deficits
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Universtiy
Fayetteville, North Carolina, 28311
About this study
Official title: Vestibular Rehabilitation for Chronic Central Vestibular Deficits Due to Cerebellar Dysfunction
The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.
Read the detailed description
The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.
Investigators will test the subject initially at 4 weeks, 8 weeks and 6 months post start date to assess for symptom improvement.
- Being tested
- Vestibular Rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular RehabilitationOther
standard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject
| Study group | Role | What they receive |
|---|---|---|
| Mobility | Other | Self comparison of data from pre-post intervention. Receives: Other: Vestibular Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Specific Balance Confidence Scale
Perceived self confidence with balance. 16 items are scored on a 0-100% scale. Items are totaled and then averaged. The higher the average score the higher the confidence with balance and the less likely risk there is for falling.
Measured: 2-6 months
Secondary outcomes (4)
Dizziness handicap inventory
Perceived handicap from dizziness. Items are scored on a 0, 2 or 4 point scale with adding up the total number of the 26 items. The lower the score, the less perceived amount of handicap is present.
Measured: 2-6 months
Functional Gait Assessment
Gait and balance test. 10 item test rated on each item from 0-3. total score is calculated of 10 items. the higher the score the less likely risk for falling is present.
Measured: 2-6 months
Motion Sensitivity Quotient
Motion sickness indicator. 16 items are scored based on symptom severity and duration. positive items are calculated together to receive a percentage. the lower the percentage the less motion sensitivity a person has.
Measured: 2-6 months
Modified Clinical Test for Sensory Integration in Balance
balance test for sensory system inputs. 6 item test to check for sensory integration with balance. each of the 6 items is calculated for length of time and amount of sway. the less the sway, the lower the score and the better the balance.
Measured: 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Nov 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
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
- Not applicable
- Intervention model
- Single group
- Model description
- Case study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist University, North Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacia Hall, Methodist University, North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952936
- Sponsor's protocol ID
- 5/14/2020 CVD
- Status last verified
- Oct 2023
- First submitted
- 14 May 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation for Chronic Central Vestibular Deficits Due to Cerebellar Dysfunction
- ClinicalTrials.gov ID
- NCT03952936
- Acronym / sponsor ID
- 5/14/2020 CVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Methodist University, North CarolinaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.
Detailed description
The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.
Investigators will test the subject initially at 4 weeks, 8 weeks and 6 months post start date to assess for symptom improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case study
| Arm | Type | Receives |
|---|---|---|
| Mobility | Other | Other: Vestibular RehabilitationSelf comparison of data from pre-post intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Central vestibular deficits
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Vestibular Rehabilitationstandard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject | Other | Mobility |
Primary outcome
Activity Specific Balance Confidence Scale
Time frame: 2-6 months
Perceived self confidence with balance. 16 items are scored on a 0-100% scale. Items are totaled and then averaged. The higher the average score the higher the confidence with balance and the less likely risk there is for falling.
4 secondary outcomes
Dizziness handicap inventory
Time frame: 2-6 months
Functional Gait Assessment
Time frame: 2-6 months
Motion Sensitivity Quotient
Time frame: 2-6 months
Modified Clinical Test for Sensory Integration in Balance
Time frame: 2-6 months
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 23 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Vestibular Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
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 Vestibular Rehabilitation in people with Vestibular Disorder and Fall, run by Methodist University, North Carolina 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 1 inclusion and 1 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 23 Oct 2023. 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?
Activity Specific Balance Confidence Scale (time frame: 2-6 months). 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 23 Oct 2023.