Clinical trial NCT02867683: Vibrotactile Feedback During Vestibular Therapy
Official title: The Effects of Vibrotactile Feedback During Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disease
Keywords: vibrotactile feedback
vestibular rehabilitation
balance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2016-08-16
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sensory Organization Testing
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
measure: Change in 10-meter walk test
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
measure: Change in Dynamic Gait Index and Functional Gait Assessment
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
measure: Change in Five Times Sit to Stand
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Secondary outcomes:
measure: Change in Activities-specific Balance Confidence Scale
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
measure: Change in Dizziness Handicap Inventory
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
measure: Change in Short Form-12
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks, & 30 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References: