Vibratory Stimulation to Improve Balance Recovery

NCT05702801 | Not Yet Recruiting

• 1 other identifier: STUDY00000207
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Balance recovery; stochastic stimulation intervention; Older adults

Outcome Measures

Primary Outcomes (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).

  Baseline for with and without SVS conditions

Study Arms (1)

Exposure to stochastic vibratory stimulation

EXPERIMENTAL

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

Device: Stochastic Vibratory Stimulation (SVS)

Interventions

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.

Exposure to stochastic vibratory stimulation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

Location

Central Study Contacts

Nima Toosizadeh, PhD

CONTACT

5204445265; ntoosizadeh@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: September 20, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

US (1)