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Vibrotactile Feedback During Vestibular Therapy

The Effects of Vibrotactile Feedback During Vestibular Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02867683
Enrollment
27
Registered
2016-08-16
Start date
2013-10-31
Completion date
2018-01-31
Last updated
2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Disease

Keywords

vibrotactile feedback, vestibular rehabilitation, balance

Brief summary

This study evaluates the use of vibrotactile feedback to traditional vestibular treatment protocols. Half the patients will have vibrotactile feedback added to their treatment protocols while the other half will undergo traditional vestibular treatment without vibrotactile feedback.

Detailed description

Vestibular and balance rehabilitation is an effective way to improve balance for individuals with balance impairments by using the strategies of adaptation, habituation, or substitution. Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with uncompensated unilateral vestibular hypofunction or bilateral vestibular loss, recovery/adaptation is often incomplete and chronic balance impairments result. Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace disrupted or absent vestibular function. The sensory information replaces disrupted or absent vestibular function to give persons additional signals about their body position in space. Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term benefits of training with VTF on balance and function have not been examined.

Interventions

Balance training Vibrotactile feedback applied to the trunk

Sponsors

University of Michigan
CollaboratorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* unilateral peripheral vestibular hypofunction * bilateral peripheral vestibular hypofunction

Exclusion criteria

* confounding neurologic or neuromuscular disorders * pregnancy * inability to stand for 3 minutes * recent lower extremity fracture/severe sprain within the last 6 months * previous lower extremity joint replacement * incapacitating back or lower extremity pain * body too large for equipment

Design outcomes

Primary

MeasureTime frameDescription
Change in Sensory Organization TestingBaseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksPostural sway data will be collected during Computerized Dynamic Posturography using the NeuroCom Equitest.
Change in 10-meter walk testBaseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksParticipants preferred gait velocity will be assessed while walking in a straight path by timing 10-meter walk.
Change in Dynamic Gait Index and Functional Gait AssessmentBaseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksMeasures that assess ability to modify walking in the presence of external demands. Includes tasks such walking with head turns, walking around obstacles, stepping over obstacles, and negotiating stairs. Each task is scored on a 4 point scale (0-3) and a total score is compiled.
Change in Five Times Sit to StandBaseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksA stopwatch is used to record the amount of time it takes the participant to move from a seated position to a standing position back to seated without using their hads for a total of 5 repetitions

Secondary

MeasureTime frameDescription
Change in Dizziness Handicap InventoryBaseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksA self-report instrument which the participants indicates whether or not the listed 25 activities cause dizziness.
Change in Short Form-12Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksA 12 question self-report instrument that provide information about mental and physical functioning as well as health-related quality of life
Change in Activities-specific Balance Confidence ScaleBaseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeksA 16-item self-report instrument which the participants completes by scoring their perceived confidence level during activities of daily living.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026