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: Completed NA study of Fall and Dizziness Chronic, sponsored by New York University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Visual Vertigo Analogue Scale (VVAS) is a self-reported questionnaire where a participant rates their visual vertigo on a 10 cm line in 9 different visually challenging environments. A score of 0 indicates no dizziness. Maximal score is 100 (calculated as the measurement on each item X 9 divided by 10). A higher score indicates worse 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 |
What the finished NCT04268745 record still lists
NCT04268745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,306-participant average among 19 other Fall trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Where NCT04268745's enrollment target sits among peer trials
30 14th of 19 higher than 5 of 19 other Fall trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fall trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI