Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation
This study is currently recruiting participants.
Verified March 2013 by Rehabilitation Institute of Chicago
Sponsor:
Rehabilitation Institute of Chicago
Collaborators:
Edward Hines Jr. VA Hospital
Information provided by (Responsible Party):
Arun Jayaraman, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01672658
First received: August 14, 2012
Last updated: March 5, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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:
- 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.
- 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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury Vestibular Deficits |
Device: Sensory Kinetics Balance System Other: Traditional Vestibular Rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Standard Vestibular Rehabilitation Training (VRT) vs. Sensory Kinetics Balance System (SKBS) + VRT on Balance and Functional Outcomes in the Mild Traumatic Brain Injury (mTBI) Population. |
Resource links provided by NLM:
Further study details as provided by Rehabilitation Institute of Chicago:
Primary Outcome Measures:
- Berg Balance Scale [ Time Frame: Pre-training,change from baseline to mid training (4 weeks), change from bseline to post training (8 weeks) ] [ Designated as safety issue: Yes ]14 item measure designed to assess static balance and fall risk.
- Functional Gait Assessment (FGA) [ Time Frame: pre-training,change from baseline to mid-training (4 weeks), change from baseline to post-training (8weeks) ] [ Designated as safety issue: Yes ]Assesses postural stability during walking tasks.
- Modified Clinical Test of Sensory Interaction and Balance (CTSIB) [ Time Frame: pre-training, change from baseline to mid-training (4 weeks) and change from baseline to post-training (8 weeks) ] [ Designated as safety issue: Yes ]Assesses balance under a variety of conditions including vision blocked and surface challenges.
Secondary Outcome Measures:
- 10 meter walk test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]assesses walking speed of short duration
- Activities-specific and Balance Confidence Scale (ABC): [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]Subjective measure of confidence in performing various ambulatory activities without falling
- Dizziness Handicap Inventory [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]if dizziness is present: assesses the degree of disability associated with any cause of dizziness.
- Six Minute walk test [ Time Frame: Pre-training, mid training (4 weeks), post training (8 weeks) ] [ Designated as safety issue: No ]Assesses distance walked over 6 minutes
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sensory Kinectics Balance System
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
Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
|
|
Active Comparator: Traditional Vestibular Rehabilitation
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
Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672658
Contacts
| Contact: Arun Jayaraman, PT, PhD | 312-238-6875 | ajayaraman@ric.org |
| Contact: Gayatri R Mathur, PT | 312-238-3840 | gmathur@ric.org |
Locations
| United States, Illinois | |
| Rehabilitation Institute of Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Arun Jayaraman, PhD 312-238-6875 ajayaraman@ric.org | |
| Contact: Gayatri Mathur, PT 312-238-3840 gmathur@ric.org | |
| Principal Investigator: Arun Jayaraman, PT, Phd | |
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Edward Hines Jr. VA Hospital
Investigators
| Principal Investigator: | Arun Jayaraman, PT, PhD | Rehabilitation Institute of Chicago |
More Information
No publications provided
| Responsible Party: | Arun Jayaraman, Research Scientist, Rehabilitation Institute of Chicago |
| ClinicalTrials.gov Identifier: | NCT01672658 History of Changes |
| Other Study ID Numbers: | NUSTU58913 |
| Study First Received: | August 14, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rehabilitation Institute of Chicago:
|
TBI, vestibular |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013