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Vestibular Training for Balance Improvement

N/A
Waitlist Available
Led By Daniel M Merfeld, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intervention first group: days 1, 6, 13, 36, 41; placebo first group: days 1, 6, 11, 18, 41
Awards & highlights

Study Summary

This trial studies a 6-day program to improve perception of body tilts and balance, with pre- and post-tests and 100-300 reps of training each day.

Who is the study for?
This trial is for healthy adults who can stand without assistance, have no leg or foot amputations, no lower limb braces, are not dizzy/lightheaded, not pregnant, and weigh under 275 pounds. It excludes those with vestibular disorders (except age-related), neurologic conditions affecting balance, recent surgeries or severe injuries to the upper body or eyes.Check my eligibility
What is being tested?
The study tests a perceptual learning protocol aimed at improving balance by training participants' perception of their body's tilts. Over six days, they undergo pre-tests, multiple training repetitions using feedback during passive body tilts and post-tests to assess changes in perception and balance.See study design
What are the potential side effects?
Since this intervention involves passive movement exercises designed to improve balance and perception without medication or invasive procedures, side effects are minimal but may include temporary dizziness or nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intervention first group: days 1, 6, 13, 36, 41; placebo first group: days 1, 6, 11, 18, 41
This trial's timeline: 3 weeks for screening, Varies for treatment, and intervention first group: days 1, 6, 13, 36, 41; placebo first group: days 1, 6, 11, 18, 41 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Postural Sway during the Sensory Organization Test
Change in Vestibular Roll Tilt Perceptual Thresholds
Change in the Postural Sway During the Modified Romberg Balance Test
Secondary outcome measures
Change in Pass/Fail Performance on the Modified Romberg Balance Test
Change in the Time to Failure During the Modified Romberg Balance Test

Trial Design

8Treatment groups
Experimental Treatment
Group I: Training Protocol 4 - Placebo FirstExperimental Treatment2 Interventions
Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds AND improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.
Group II: Training Protocol 4 - Intervention FirstExperimental Treatment2 Interventions
Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds AND improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.
Group III: Training Protocol 3 - Placebo FirstExperimental Treatment2 Interventions
Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.
Group IV: Training Protocol 3 - Intervention FirstExperimental Treatment2 Interventions
Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, three-down, one-up (3D/1U), or six-down, one-up (6D/1U) staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.
Group V: Training Protocol 2 - Placebo FirstExperimental Treatment2 Interventions
Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, left anterior/right posterior (LARP) tilt, or right anterior/left posterior (RALP) tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.
Group VI: Training Protocol 2 - Intervention FirstExperimental Treatment2 Interventions
Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, three-down, one-up (3D/1U), or six-down, one-up (6D/1U) staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.
Group VII: Training Protocol 1 - Placebo FirstExperimental Treatment2 Interventions
Participants will complete a roll tilt training protocol previously shown to reduce roll tilt thresholds. The training stimulus parameters are as follows: 0.5 Hz roll tilt motion, stimulus size will be adjusted based upon subject responses using a 2D/1U staircase, and only auditory feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.
Group VIII: Training Protocol 1 - Intervention FirstExperimental Treatment2 Interventions
Participants will complete a roll tilt training protocol previously shown to reduce roll tilt thresholds. The training stimulus parameters are as follows: 0.5 Hz roll tilt motion, stimulus size will be adjusted based upon subject responses using a 2-down, 1-up (2D/1U) staircase, and only auditory feedback will be provided.The training protocol will be completed first, followed by the placebo intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Intervention
2011
N/A
~610

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Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,703 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,023 Total Patients Enrolled
13 Trials studying Healthy Aging
1,514 Patients Enrolled for Healthy Aging
Daniel M Merfeld, PhDPrincipal InvestigatorOhio State University

Media Library

Placebo Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05818787 — N/A
Healthy Aging Research Study Groups: Training Protocol 2 - Intervention First, Training Protocol 2 - Placebo First, Training Protocol 3 - Intervention First, Training Protocol 1 - Intervention First, Training Protocol 1 - Placebo First, Training Protocol 3 - Placebo First, Training Protocol 4 - Intervention First, Training Protocol 4 - Placebo First
Healthy Aging Clinical Trial 2023: Placebo Intervention Highlights & Side Effects. Trial Name: NCT05818787 — N/A
Placebo Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05818787 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment offering enrollment opportunities at the present time?

"The clinicaltrials.gov portal reveals that this trial is not recruiting participants at present, as the last update was made on April 5th 2023. Although there are no patients being sought for this particular study currently, 52 other trials are actively seeking individuals to join their research teams."

Answered by AI

Does this investigation accept volunteers aged 50 and up?

"This study has 2 distinct enrollment criteria, with those under 18 years old being limited to 1 trial and those over 65 needing to join 50 studies."

Answered by AI

Who is eligible to partake in this experiment?

"This research trial is recruiting 40 participants aged 65 to 89 who are in good health. To qualify, applicants must demonstrate the ability to stand up unaided, not feel dizzy or lightheaded, and have no history of lower limb amputations nor bracing."

Answered by AI
~27 spots leftby Dec 2025