Sensory Training for Orientation and Balance

NCT04331561 | Withdrawn

• 4 other identifiers: 2020-0087A176000EDUC/KINESIOLOGYProtocol Version 12/22/2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness; Vertigo; Dizziness; Fall

Outcome Measures

Primary Outcomes (3)

• Percent of Participants Enrolled Relative to Approached

  Study feasibility is a primary outcome of this study. Feasibility will be measured using enrollment rates: the number of participants enrolled relative to the number of potential participants approached. This study will be considered 'feasible' with an enrollment rate higher than 70%

  Up to 30 minutes

• Participant Drop out Rate

  Tolerance of the intervention is a primary outcome of this study. Tolerance will be measured using the participant drop out rate. This study will be considered tolerable if the drop out rate is less than 20%

  Up to 3 weeks

• Post-Intervention Virtual Reality Sickness Questionnaire (VRSQ) Score

  This questionnaire will be administered on paper immediately following each instance of testing and each round of training. Additional rest time will be required if participants symptoms are scored as \> 33% on the VRSQ (see below for more information regarding VRSQ scoring). Symptoms must return to baseline before participants are permitted to begin a round of testing or training. The VRSQ is comprised of nine items from two domains (oculomotor: general discomfort, fatigue, eye strain, and difficulty focusing; disorientation: headache, fullness of head, blurred vision, dizzy (eyes closed), and vertigo). The intensity of each item is rated on a 4-point Likert scale: 0 = not at all, 1 = slightly, 2 = moderately, and 3 = very. Scores for each sub-scale and the total score range from 0 to 100. Higher scores indicate greater symptom intensity. The VRSQ is an adaptation of the Simulator Sickness Questionnaire (SSQ) for use in virtual environments.

  Visit 3 (Week 2)

Secondary Outcomes (8)

• Change in Motion Sensitivity Assessment Questionnaire (MSAQ) Overall Score

  Visit 1 (Week 1) and Visit 3 (Week 2)

• Change in Visual Vertical Analogue Scale (VVAS) Total Score

  Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)

• Change in Vision-related Dizziness Questionnaire (VRDQ) Total Score

  Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)

• Change in Rod and Disk Test (RDT) Mean Performance

  Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)

• Change in Subjective Visual Vertical (SVV) Mean Performance

  Visit 1 (Week 1), Visit 2 (in Week 2), Visit 3 (in Week 2)

Study Arms (1)

Sensory Re-weighting

EXPERIMENTAL

Adults with self-reported visually-induced dizziness will be recruited to help establish the feasibility and tolerability of the testing and training methods, as well as observe for any effects of the sensory re-weighting intervention. Tests involve assessing motion sickness, vision, somatosensation, balance, and perception of verticality. The treatment provided is designed to facilitate re-weighting of sensory feedback for orientation and balance. Participants will serve as their own controls.

Behavioral: sensory re-weighting

Interventions

sensory re-weighting BEHAVIORAL

Participants will be supported in quiet standing by a safety harness and crisscrossing strap system. A cervical collar will be used to maintain consistent alignment between the head and trunk. A virtual reality headset is used to create a virtual environment in which visual stimuli will be presented. Three different body positions will be used during training: earth-vertical and clockwise and counterclockwise tilted 16º in the frontal plane. Sensory re-weighting will be driven by priming upregulation of somatosensory cues. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity.

Sensory Re-weighting

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Motion Sickness; Vertigo; Dizziness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Sensation Disorders

Study Officials

• Kreg G Gruben, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking is not practical for this pilot trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized, single group design with 2 baseline and 1 post-treatment assessment time points

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)