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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Falls are the primary cause of traumatic injury in older adults, and tripping is the leading cause of falls. A robust method for improving aging-related proprioceptive deficits is lacking, while strong evidence shows that proprioception deficits are highly associated with poor balance recovery from tripping. Previous research suggested that stochastic vibratory stimulation (SVS) can influence proprioception (i.e., muscle spindle function) among healthy controls; however, it is not clear how older adults with deficits in muscle spindle function would react to SVS. In previous work the investigators showed promising findings of standing balance and timed-up-and-go (TUG) improvements using SVS among high fall risk older adults with history of fall 15-18. They will implement SVS in the current project to improve aging-related proprioceptive deficits. The hypothesis is that SVS improves muscle spindle function and balance recovery from tripping in older adults with proprioceptive deficits.

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 data supports the effectiveness of the treatment Stochastic Vibratory Stimulation (SVS) for falling?

Research shows that applying vibratory stimulation to the feet can reduce walking variability and improve balance in older adults, which may help prevent falls. Studies have found that this type of stimulation can decrease fluctuations in foot movement and improve stability during walking, suggesting it could be effective in reducing fall risk. ^{1 2 3 4 5}

Is vibratory stimulation safe for humans?

Research on vibratory stimulation, including stochastic vestibular stimulation (SVS) and subsensory vibrations, suggests it is generally safe for humans. Studies have shown that low levels of SVS can improve stability without causing discomfort, and subsensory vibrations to the feet have been used to reduce gait variability in elderly individuals without reported safety concerns. ^{1 2 4 6 7}

How is Stochastic Vibratory Stimulation (SVS) different from other treatments for falling?

Stochastic Vibratory Stimulation (SVS) is unique because it uses gentle vibrations applied to the skin to enhance sensory feedback, which can improve balance and coordination. This approach targets the sensory system rather than just focusing on muscle strength, making it different from traditional rehabilitation methods that primarily address motor control. ^{8 9 10 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Subsensory vibrations to the feet reduce gait variability in elderly fallers. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Subthreshold white noise vibration alters trembling sway in older adults. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Alterations in the ability to maintain balance as a result of stochastic resonance whole body vibration in women. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Using low levels of stochastic vestibular stimulation to improve locomotor stability. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Reducing the foot trajectory variabilities during walking through vibratory stimulation of the plantar surface of the foot. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Electrical vestibular stimuli to enhance vestibulo-motor output and improve subject comfort. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Temporal correlations in postural sway moderate effects of stochastic resonance on postural stability. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Vibratory stimulation increase the electro-cutaneous sensory detection and pain thresholds in women but not in men. [2018]

9. Japan 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A novel pneumatic stimulator for the investigation of noise-enhanced proprioception. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of manual segmental vibration on neuromuscular excitability. [2004]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Steady-state vibration somatosensory evoked potentials: physiological characteristics and tuning function. [2019]