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.
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
- Are there results?
- Not yet: the study is under way
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.
United States1 site, 1 recruiting
- Recruiting
Rutgers, State University of New Jersey
Newark, New Jersey, 07107
Nima Toosizadeh, PhD, 520-444-5265, nima.toosizadeh@rutgers.edu
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 group | Role | What they receive |
|---|---|---|
| Exposure to stochastic vibratory stimulation | Experimental | All 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.
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.
- First posted27 Jan 2023
- Study start1 May 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Nima Toosizadeh, PhD, Rutgers, The State University of New Jersey
- Investigators
- Nima Toosizadeh, PhD, Principal investigator, Rutgers University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subsensory Stochastic Vibratory Stimulation to Assess and Improve Aging Related Proprioceptive Deficits Associated With Balance Recovery
- ClinicalTrials.gov ID
- NCT05702801
- Acronym / sponsor ID
- Pro2023002282
- Conditions
- Fall, Fall Injury
- Keywords
- Balance recovery, stochastic stimulation intervention, Older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure to stochastic vibratory stimulation | Experimental | Device: Stochastic Vibratory Stimulation (SVS)All participants will be exposed to vibratory stimulations at different levels of 0Hz, 40Hz, and 80Hz. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65 years or older
- the ability to understand study instructions.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Exposure to stochastic vibratory stimulation |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nima Toosizadeh, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nima Toosizadeh, PhD (5204445265, ntoosizadeh@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance recovery outcomes (time frame: Baseline for with and without SVS conditions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.