Clinical trial NCT04331561: Sensory Training for Orientation and Balance
Official title: Sensory Re-weighting Training for Orientation and Equilibrium: A Pilot Trial for the Treatment of Visually-induced Dizziness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Motion Sickness
Vertigo
Dizziness
Fall
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2020-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, single group design with 2 baseline and 1 post-treatment assessment time points
Primary purpose: TREATMENT

Brief summary: This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. The researchers will use the new tests and treatments with adults who are affected by visually-induced dizziness. Testing is done twice before and once after treatment. The total time participants are involved in the study is approximately two weeks.

Detailed description: This is a preliminary study of how human beings control balance and how symptoms of visually-induced dizziness may result in falls. The researchers created new tests of orientation and balance, as well as a new treatment for visually-induced dizziness. It is not known whether the new tests of orientation and balance are better, worse, or the same as existing tests in the ability to detect problems, nor is it known if the new treatment technique is any better, worse, or the same as existing treatments for dizziness and imbalance. However, the researchers hypothesize that the new tests will improve the ability to detect problems. They hypothesize that the treatment will result in less dizziness, better balance, and reduced risk of falling for those who receive it and that it is a better alternative to treatments that are already available to patients.

In order to see if this is true, the researchers will use the new tests and treatments with adults who are affected by dizziness. All participants in this study will undergo the same tests and will receive the same treatment. Testing is done twice before and once after the treatment period. The tests and treatment are done while standing on a computerized platform that measures balance and can tilt people from side to side. During these study procedures, participants wear virtual reality goggles that show them simple images in an otherwise dark environment.

The goal of the tests and the treatment is for participants to use what they feel to help them decide if the images shown inside the goggles are aligned with the person's sense of gravity. Participation in this study is voluntary and people who decide to participate may stop at any time without penalty.

Eligibility criteria: Inclusion Criteria:

* Participants must have self-reported symptoms of visually-induced dizziness
* Participants must have normal self-reported cognitive function
* Participants must speak English fluently
* Weigh less than 225 pounds
* Be able to support their body weight in an upright posture for 15 minutes at a time
* Be able to follow the guidelines regarding permitted and prohibited additional treatments outlined in the study protocol.

Exclusion Criteria:

* Participants must not be participating in vestibular and balance rehabilitation therapy
* Pregnant or planning to become pregnant while in "on study" status
* Best-corrected visual acuity \> 20/70
* Any self-reported, uncompensated, binocular vision abnormality, such as strabismus, amblyopia, or diplopia
* Peripheral neuropathy
* Self-reported history of frequent syncope (\>1/month).

Primary outcomes:
measure: Percent of Participants Enrolled Relative to Approached
timeFrame: Up to 30 minutes
measure: Participant Drop out Rate
timeFrame: Up to 3 weeks
measure: Post-Intervention Virtual Reality Sickness Questionnaire (VRSQ) Score
timeFrame: Visit 3 (Week 2)
Secondary outcomes:
measure: Change in Motion Sensitivity Assessment Questionnaire (MSAQ) Overall Score
timeFrame: Visit 1 (Week 1) and Visit 3 (Week 2)
measure: Change in Visual Vertical Analogue Scale (VVAS) Total Score
timeFrame: Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)
measure: Change in Vision-related Dizziness Questionnaire (VRDQ) Total Score
timeFrame: Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)
measure: Change in Rod and Disk Test (RDT) Mean Performance
timeFrame: Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)
measure: Change in Subjective Visual Vertical (SVV) Mean Performance
timeFrame: Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)
measure: Change in Rod and Frame Test (RFT) Mean Performance
timeFrame: Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)
measure: Change in Multisensory Balance Evaluation (MBE) as measured by the Intersection Point Height
timeFrame: Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)
measure: Change in Semmes-Weinstein Monofilament Examination (SWME) Discrimination Threshold
timeFrame: Visit 2 (in Week 2) and Visit 3 (in Week 2)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kreg G Gruben, PhD
role: PRINCIPAL_INVESTIGATOR
References: