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FallNCT05702801

Vibratory Stimulation to Improve Balance Recovery

A study testing Stochastic Vibratory Stimulation (SVS) in people with Fall and Fall Injury, run by Rutgers, The State University of New Jersey at 1 site in United States.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Fall, Fall Injury
What is being tested?
Stochastic Vibratory Stimulation (SVS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 May 2024to 1 Sep 2029
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nima Toosizadeh, PhD contact

5204445265

ntoosizadeh@arizona.edu

United States1 site, 1 recruiting
  • Rutgers, State University of New Jersey

    Newark, New Jersey, 07107

    Nima Toosizadeh, PhD, 520-444-5265, nima.toosizadeh@rutgers.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Fall, Fall Injury
Being tested
Stochastic Vibratory Stimulation (SVS)
Keywords
Balance recovery, stochastic stimulation intervention, Older adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stochastic Vibratory Stimulation (SVS)Device

    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.

Study groups in NCT05702801
Study groupRoleWhat they receive
Exposure to stochastic vibratory stimulationExperimentalAll participants will be exposed to vibratory stimulations at different levels of 0Hz, 40Hz, and 80Hz.
Receives: Device: Stochastic Vibratory Stimulation (SVS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance recovery outcomes

    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).

    Measured: Baseline for with and without SVS conditions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start1 May 2024
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05702801
Sponsor's protocol ID
Pro2023002282
Status last verified
Jul 2026
First submitted
18 Jan 2023
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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