Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

NCT01672658 | Completed Results

• 1 other identifier: NUSTU58913
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study at RIC is to determine the value and benefit of the SK multimodal balance training system through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in balance and functional assessments. This study is primarily funded through Engineering Acoustics as a subcontract for a phase II Small Business Innovation Research by the Department of Defense. 3\) Hypotheses \& Research Objectives and Purpose: The specific research questions to be addressed are:

1. 1.How does an 8-week SKBS+VRT training intervention compare to an 8-week standard VRT intervention on balance and functional gait measures in mild traumatic brain injury (mTBI) participants.
2. 2.How do SKBS measurement tools compare to standard clinical assessments of gait and balance in mTBI patients The purpose of this clinical research study is to compare the value and benefit of the SK multimodal balance training system in combination with traditional vestibular rehabilitation vs. traditional vestibular rehabilitation alone through independent clinical evaluations. The functional benefit of the SK Balance system will be measured by any improvements in clinical measures of balance, functional mobility, and gait assessment.

Conditions

Traumatic Brain Injury; Vestibular Deficits

Keywords

TBI,; vestibular

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale

  The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.

  Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)

• Functional Gait Assessment (FGA)

  Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect. 10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment 1. = moderate impairment 2. = mild impairment 3. = normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device

  Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)

Secondary Outcomes (6)

• 10 Meter Walk Test

  Pre-training, mid training (4 weeks), post training (8 weeks)

• Six Minute Walk Test

  Pre-training, mid training (4 weeks), post training (8 weeks)

• Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed

  Pre-training, mid training, post training

• Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open

  Pre-training, mid training (4 weeks), post training (8 weeks)

• Activities Balance Confidence Scale (ABC)

  Pre-training, mid training, post training

Study Arms (2)

Sensory Kinectics Balance System

EXPERIMENTAL

Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.

Device: Sensory Kinetics Balance System

Traditional Vestibular Rehabilitation

ACTIVE COMPARATOR

Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.

Other: Traditional Vestibular Rehabilitation

Interventions

Sensory Kinetics Balance System DEVICE

Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.

Sensory Kinectics Balance System

Traditional Vestibular Rehabilitation OTHER

Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.

Traditional Vestibular Rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate Traumatic Brain Injury
• Adults 18 years-75 years old
• Vestibular \&/or balance deficit following mild/moderate TBI and confirmed by healthcare professional
• Subjects reporting head injury from exposure to a blast/concussion injury with one or more of the following symptoms: dizziness, vertigo, headache, migraine, oscillopsia, movement induced vertigo.
• Able to sit unaided for two minutes
• Able to stand independently with or without a cane, or with no more than moderate assistance from the physical therapist/researcher.

You may not qualify if:

• Multiple trauma
• Severe brain injury as defined above
• Pacemakers
• Weight greater than 250 lbs
• Mini Mental Status Exam score of less than 24 and/or Cognitive Log score of less than 25
• A diagnosis of:
• Peripheral neuropathy
• Severe neuromuscular diseases
• Severe Cardiovascular disease
• Associated high-level stroke or spinal cord injury
• Amputees

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• United States Department of Defense: collaborator
• Edward Hines Jr. VA Hospital: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Arun Jayaraman, PT, PhD
• Organization: Rehabilitation Instititute of Chicago

a-jayaraman@northwestern.edu

312-238-2091

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 27, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: November 1, 2014
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Locations

US (1)