Recruiting

SVS

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05702801

Conditions

Fall

Fall Injury

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Stochastic Vibratory Stimulation (SVS)

Study Details

Brief summary:

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.

Conditions

Fall

Fall Injury

Study ID

NCT05702801

Start date

May 1, 2024

Status verified date

Jul, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • age 65 years or older
  • the ability to understand study instructions.

Exclusion Criteria:

  • disorders associated with severe motor and balance deficits, including stroke, Parkinson's disease, severe arthritis, lower-extremity amputation, spinal cord pathologies (e.g., spinal stenosis), and diabetes
  • history of severe vestibular disorder such as bilateral vestibular hypofunction or poorly-compensated unilateral vestibular hypofunction, or Dizziness Handicap Inventory (DHI) > 40
  • central nervous disease
  • cognitive impairment (MoCA score<20)
  • vision problems including cataract, presbyopia, and similar problems that can influence balance
  • sedating medication or alcohol consumption within 24 hours.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Exposure to stochastic vibratory stimulation

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

Interventions

Stochastic Vibratory Stimulation (SVS)

Investigators implement stochastic vibratory stimulation (SVS) to alter proprioceptive performance by increasing excitement of type Ia afferents in muscle spindles. Based on previous preliminary data, vibration frequencies around 40Hz may provide adequate noise for enhancing aging-related proprioceptive deficits. To make a subsensory noise investigators set it to 90% of the sensory threshold amplitude, which has been effectively used previously for influencing mechanoreceptor sensation in older adults. Stimulation will be imposed bilaterally on: 1) distal ankle (tibialis anterior, peroneus longus, soleus, gastrocnemius); and 2) proximal hip (quadriceps, gluteus medius, and paraspinals). Investigators use Gaussian noise to reduce the anticipative and preemptive adjustments of muscle spindles to the vibration. For SVS investigators use a magnetic actuator system and a Universal Controller (C-2HDLF Tactor/TDK), to provide programmable frequency ranges.

Primary outcome measure

  • Balance recovery outcomes [ Time Frame: Baseline for with and without SVS conditions ]

Central Contacts and Locations

Central contacts

Nima Toosizadeh, PhD

5204445265ntoosizadeh@arizona.edu

Locations

Rutgers, State University of New Jersey

Recruiting

Newark, New Jersey, United States, 07107

Contacts

Nima Toosizadeh, PhD

520-444-5265nima.toosizadeh@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Balance recovery
  • stochastic stimulation intervention
  • Older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.