Vibratory Stimulation to Improve Balance Recovery

July 6, 2026 updated by: Nima Toosizadeh, PhD, Rutgers, The State University of New Jersey

Subsensory Stochastic Vibratory Stimulation to Assess and Improve Aging Related Proprioceptive Deficits Associated With Balance Recovery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study investigators will assess the application of a novel methodology, stochastic vibratory stimulation (SVS), for enhancing proprioceptive performance in high fall risk older adults. It is hypothesized that SVS can alter muscle spindle activation. In high fall risk older adults, this additional activation effect on muscle spindle can improve deficits in proprioception. Two groups of low and high fall risk older adults, aged 65 and older, will be recruited. Both groups will go through several testing, including fall risk assessment, clinical questionnaires, proprioceptive measurement, and treadmill perturbation. Investigators will perform Stopping Elderly Accidents, Deaths & Injuries (STEADI) for fall screening, which includes: 1) fall history, unsteadiness, and fear of falling; 2) timed-up-and-go; 3) 30-second chair stand; and 4) four stage Romberg balance test. Questionnaires include: 1) fear of falling (Falls Efficacy Scale-International (FES-I)); 2) cognition (Montreal Cognitive Assessment - MoCA); 3) comorbidity (CMS Hierarchical Condition Category - CMS-HCC); 4) depression (Patient Health Questionnaire - PHQ-9); 5) pain in lower-extremity (Visual Analog Scale - VAS); and 6) vestibular-related symptoms (Dizziness Handicap Inventory - DHI). For proprioceptive measurement, investigators will assess joint position sense for ankle and hip with and without SVS. In both tests, participants perform the assessments in a safe platform. For the ankle joint, investigators will assess targeted angles of 5° and 10° plantarflexion and 5° dorsiflexion in random order. For the hip joint, participants will flex the trunk and be instructed to stop at 25, 50, and 75% of the range of motion in a random order. Further, both groups of participants will be exposed to low-speed treadmill perturbation (sudden backward treadmill movement to impose a trip-like disturbance) with and without SVS. During the perturbation, participants will be protected from falling using a secure harness. SVS will be applied to the ankle and hip muscles randomly in two separate sessions to influence proprioceptive performance from each of these sites. For the ankle joint SVS will be applied to tibialis anterior, peroneus longus, soleus, gastrocnemius, and for the hip joint it will be applied to quadriceps, gluteus medius, and paraspinals. In each session, after practicing and warming up twice at a slow treadmill speed (0.1m/s), each participant will go through six trials of perturbation within two bouts (0.35m/s), one with SVS and one without. To minimize the anticipation effect, one trial of forward belt movement will be randomly assigned (0.2m/s). All participants will be exposed to all testing conditions (ankle and hip SVS exposures). Investigators will measure balance recovery performance from the treadmill perturbation based on kinematics and muscle activity measures using wearable sensors. Kinematics outcomes will assess response time, recovery step execution, and lower-extremity and trunk motion during recovery. Assessment of muscle activity will provide insights regarding the onset of muscle activities during the balance recovery for tibialis anterior, peroneus longus, soleus, gastrocnemius, quadriceps, and paraspinals, using surface electromyography. Investigators will perform multivariable repeated measures analysis using mixed effects modeling to assess: 1) the effect of vibration area on each individual balance recovery outcome; and 2) the association between ankle (or hip) proprioceptive performance and ankle (or hip) SVS-imposed changes in balance recovery outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07107
        • Recruiting
        • Rutgers, State University of New Jersey
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exposure to stochastic vibratory stimulation
All participants will be exposed to vibratory stimulations at different levels of 0Hz, 40Hz, and 80Hz.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Balance recovery outcomes
Time Frame: Baseline for with and without SVS conditions
Investigators will extract outcomes treadmill perturbation. Failing to recover from the perturbation will be identified if the entire body weight is supported by the harness. Recoveries with integrated weight support greater than 5% of the weight × second will be classified as harness-assisted recoveries. All other recoveries will be considered successful and will be used for kinematics and muscle response analysis. Kinematics outcomes will assess response time, recovery step execution, and lower-extremity and trunk motion during recovery. Investigators will also assess muscle activities (from tibialis anterior, peroneus longus, soleus, gastrocnemius, quadriceps, and paraspinals).
Baseline for with and without SVS conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nima Toosizadeh, PhD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2023002282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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