Vibratory Stimulation for Falling

Overseen By Nima Toosizadeh, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Sedatives, Alcohol

Disqualifiers: Stroke, Parkinson's, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how vibratory stimulation might improve balance in older adults who frequently trip and fall. The goal is to determine if Stochastic Vibratory Stimulation (SVS) can enhance muscle function related to balance and reduce fall risk. Participants will experience various vibration levels to assess its effects. The trial targets individuals 65 and older who struggle with balance but do not have severe motor disorders or major vision issues. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to improved balance solutions for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should avoid sedating medications or alcohol within 24 hours of participation.

What prior data suggests that this method is safe for older adults with proprioceptive deficits?

Research has shown that stochastic vibratory stimulation (SVS) is generally safe and well-tolerated. Past studies have used SVS to improve balance and stability without significant side effects. For instance, low levels of SVS effectively enhanced stability while walking, indicating safety at these levels.

In another study, participants wore a harness to prevent falls during SVS application, demonstrating the safety precautions taken during testing. This also suggested that the treatment itself did not cause harm. The goal was to improve the body's ability to sense movement and position without causing discomfort or harm.

Overall, these findings suggest that SVS can safely improve balance and body awareness, especially when used with proper safety measures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stochastic vibratory stimulation (SVS) because it offers a novel approach to preventing falls. Unlike traditional treatments for fall prevention, which often focus on exercise, balance training, or medication, SVS uses vibrations at specific frequencies to potentially enhance sensory feedback and improve balance. This non-invasive method could provide a new, drug-free option for individuals at risk of falling, offering a fresh alternative to current standards of care.

What evidence suggests that stochastic vibratory stimulation is effective for improving balance recovery in older adults with proprioceptive deficits?

Research shows that gentle vibrations, known as stochastic vibratory stimulation (SVS), can help older adults enhance their balance and body movement awareness. Previous studies found that SVS enabled seniors at high risk of falling to stand more steadily and perform better on the "Get Up and Go" (TUG) test. Other research has shown that special vibrating shoe inserts can significantly improve balance and reduce the risk of falls. Additionally, studies report noticeable improvements in balance after using SVS. These findings suggest that SVS might enhance muscle function related to balance and decrease the chance of falls in older adults. In this trial, participants will experience vibratory stimulations at levels of 0Hz, 40Hz, and 80Hz to evaluate its effects on balance and fall risk. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older who can follow study instructions. It's not for those with central nervous diseases, severe motor and balance issues like stroke or Parkinson's, major arthritis, limb loss, spinal problems, serious vestibular disorders, cognitive impairment (low MoCA score), significant vision issues affecting balance, or recent sedative or alcohol use.

Inclusion Criteria

The ability to understand study instructions

I am 65 years old or older.

Exclusion Criteria

I have vision issues like cataracts that affect my balance.

I have a condition affecting my brain or spinal cord.

Sedating medication or alcohol consumption within 24 hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including fall risk assessment, clinical questionnaires, proprioceptive measurement, and treadmill perturbation

1-2 weeks

2 visits (in-person)

Treatment

Participants receive stochastic vibratory stimulation (SVS) at different levels (0Hz, 40Hz, 80Hz) to assess and improve proprioceptive performance

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for balance recovery performance and muscle activity using wearable sensors

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stochastic Vibratory Stimulation (SVS)

Trial Overview The trial tests if Stochastic Vibratory Stimulation (SVS) can improve muscle function related to sensing body position and movement (proprioception) in older adults. This could help them recover their balance after tripping by enhancing the performance of muscles spindles that are crucial for stability.

How Is the Trial Designed?

Group I: Exposure to stochastic vibratory stimulation Experimental Treatment 1 Intervention

All participants will be exposed to vibratory stimulations at different levels of 0Hz, 40Hz, and 80Hz.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

The study found that the temporary threshold shift of vibratory sensation (TTS(v)) in the fingertip increases significantly with longer exposure to hand-arm vibration, indicating a clear relationship between exposure duration and sensory threshold changes.

The recovery of TTS(v) after vibration exposure follows an exponential pattern, suggesting that the time taken to return to baseline sensitivity may require improved measurement methods for more accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dependency of temporary threshold shift of vibratory sensation in fingertip on 1/3 octave-band hand-arm vibration exposure period. Nishiyama, K., Taoda, K.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05702801?cond=Fall&lastUpdPost=2020-09-09_&viewType=Table&rank=4

Vibratory Stimulation to Improve Balance Recovery In this study investigators will assess the application of a novel methodology, stochastic vibratory stimulation (SVS), for enhancing proprioceptive performance ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10149870/

Effects of stochastic resonance whole-body vibration on ... Six studies found statistically significant improvements of balance from baseline to post measurement after SR-WBV interventions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6360177/

The Promise of Stochastic Resonance in Falls Prevention - PMC Vibrotactile noisy stimulation was found to improve balance performance particularly in the older adults (Dettmer et al., 2015). This ...

4. clinicaltrial.be clinicaltrial.be/en/details/189911?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Vibratory Stimulation to Improve Balance Recovery - Clini... In this study investigators will assess the application of a novel methodology, stochastic vibratory stimulation (SVS), for enhancing ...

5. wyss.harvard.edu wyss.harvard.edu/news/study-shows-vibrating-insoles-could-reduce-falls-among-seniors/

Study Shows Vibrating Insoles Could Reduce Falls Among ... Results of this study demonstrated that the vibratory insoles significantly improved performance on the timed “Get Up and Go” test, reduced ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2093791113000279

Stochastic Resonance Whole-Body Vibration ... SR-WBV seems to be an efficient option in primary prevention of musculoskeletal complaints and falls at work. ... Vibration training, biomechanical stimulation ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4547107/

Using low levels of stochastic vestibular stimulation to improve ... This study shows the effectiveness of using low imperceptible levels of SVS to improve dynamic stability during walking on a laterally oscillating treadmill via ...