Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04268745 · ClinicalTrials.gov registry record · NA
Virtual Environments for Vestibular Rehabilitation
A NA study of Fall and Dizziness Chronic, sponsored by New York University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT04268745 is a NA study of Fall and Dizziness Chronic that has completed, run by New York University. The registered enrollment target is 30 participants, below the 1,306-participant average among 19 other Fall trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04268745, a NA study of Fall and Dizziness Chronic, has completed, sponsored by New York University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The specific aims of this pilot project are: Aim #1: Determine the extent to which sensory integration strategies differ between 28 individuals with unilateral vestibular hypofunction and 28 age-matched peers. Participants' postural sway will be recorded as they experience two levels of moving stars10 and white noise, while standing on the floor or a compliant surface. Our working hypothesis is that patients with vestibular hypofunction utilize substitution strategies such that they will demonstrate greater visual and auditory reliance compared with controls, particularly when somatosensory cues are reduced via the support surface. We will then explore whether these mechanism changes after training. Aim #2: Develop the protocol and establish the feasibility of a randomized controlled trial (RCT) comparing C.S.I. training to standard vestibular rehabilitation. Following the assessment, the 28 patients will be randomized into standard vestibular rehabilitation vs. C.S.I. training. This pilot study will enable us to test the feasibility of our recruitment, randomization procedures, establish attrition rate, and test the training protocol. Aim #3: Generate pilot data for sample size calculation for a properly powered RCT. The follow up RCT will test the effect of C.S.I. training on: Visual Vertigo Analog Scale (VVAS), Functional Gait Analysis (primary); balance confidence, overall disability (descriptive). In our preliminary study, 8 patients met the inclusion criteria for the current proposal. Following the C.S.I. training, they had a large effect size of 1.17 on the VVAS. The current study will allow us to identify the between-group effect size for the VVAS and for a functional gait outcome.
Conditions Studied
Interventions
- BEHAVIORAL Balance training
- BEHAVIORAL Traditional Vestibular Rehabilitation
Study Locations (2)
New York
- New York Eye and Ear Infirmary of Mount Sinai - New York
- New York University Physical Therapy Department - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-08-21 |
| Est. Completion | 2022-05-23 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04268745
The ClinicalTrials.gov registry entry for NCT04268745 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,306-participant average among 19 other Fall trials with a reported enrollment target (98% lower). The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Fall appearing as the primary indexed condition, and to 2 interventions - of which Balance training is the first listed.
NCT04268745 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04268745 about?
NCT04268745 is a clinical study titled "Virtual Environments for Vestibular Rehabilitation". The specific aims of this pilot project are: Aim #1: Determine the extent to which sensory integration strategies differ between 28 individuals with unilateral vestibular hypofunction and 28 age-matched peers. Participants' postural sway will be recorded as they experience two levels of moving star...
What is the current status of trial NCT04268745?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-08-21. Estimated completion is 2022-05-23.
What conditions does trial NCT04268745 study?
This clinical trial studies the following conditions: Fall, Dizziness Chronic, Vertigo, Peripheral.
What interventions are being tested in trial NCT04268745?
The interventions under investigation include: Balance training (BEHAVIORAL), Traditional Vestibular Rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04268745?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04268745 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fall
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The Geriatric Emergency Department Pharmacologic Harm Prevention Project
RECRUITING · NA
-
Optimizing a Technology-based Body and Mind Intervention
RECRUITING · NA
-
Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults
RECRUITING · NA
-
Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression
RECRUITING · NA
-
Real-life Dual-Task Training
RECRUITING · NA
-
Exercise Program for Deaf Seniors to Increase Their Balance and Fitness
ACTIVE NOT RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.