Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

Traumatic Brain Injury Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672658
• Other study ID #: NUSTU58913
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: November 3, 2014
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Rehabilitation Institute of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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. 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.

Description:

Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent neurological damage. In some cases, symptoms can continue over time and contribute to disability. Dizziness and vertigo are associated with nearly all reported studies of mild Traumatic Brain Injury (mTBI) and are a significant and functionally limiting component of the overall disability.

TBI is one of the many risks faced by military personnel in combat activities . In a RAND Corporation survey of service members who had been deployed to Iraq or Afghanistan, 19% reported probable TBI. Dizziness and vertigo are associated with nearly all reported studies of mTBI and are a significant and debilitating component of the overall disability. mTBI are currently caused by both blast and impact injuries resulting in variable disabilities . Overt symptoms may include balance and spatial disorientation problems (vertigo) related to vestibular dysfunction, vision disturbances, inner-ear edema, and/or other sensory integration deficits.

Treatment of this particular population group has several challenges which include: 1) difficulty with early and specific injury assessment 2) the determination of appropriate return-to-duty measures 3) selection of effective individualized balance rehabilitation and treatment tools 4) Prolonged length of rehabilitation and uncertain measureable endpoints. The group is also highly variable in the nature and extent of balance deficits and cognitive and / or related psychological impairments. It appears that almost all subjects with mTBI show some susceptibility to vestibular or vestibular/ocular disorders.

After assessment of disequilibrium, rehabilitation is often a course of remedial physical therapy (PT). To affect change in mobility by standard physical therapy, sensory and motor systems are "habituated" through exercise, with hope of rehabilitating the system and "compensating" by instructing the patient to alter skill sets associated with a task. Compensation (without immediate sensory feedback) is problematic and prone to patient (and caregiver) interpretation and error, because it may not address the underlying problems and may not have long term therapeutic benefits. There is also a very limited pool of PTs who specialize in the treatment of neurological problems resulting from brain injuries. Individual vestibular rehabilitation treatment programs are designed by these specialist PTs who also monitor and participate in each patient's recovery. This approach is labor intensive, time consuming (up to 14 weeks of therapy is often needed) and some patients do not recover fully .

The overall objective of this research effort is to use novel combinations of multi-modal sensory guided feedback (especially tactile) and traditional vestibular rehabilitation to retrain military personnel suffering balance disorders as a result of mTBI. The investigators therapeutic goal is to test technology that will return the patient, in the shortest period of time, to a level of balance performance consistent with return to the community and/or military duty.

The sense of touch is intrinsically linked with the neuro-motor channel, both at the reflex and higher cognitive regions, which makes it uniquely tied to orientation and localization. Vibrotactile arrays are therefore intuitive and are an effective sensory feedback pathway.

Recent research has also demonstrated that tactile cueing yield significantly faster and more accurate performance than comparable spatial auditory cues. Further research has demonstrated this finding is relatively stable across a variety of body orientations, even when spatial translation is required and under physiological stress.

Over a Phase I SBIR and current Phase II effort, Engineering Acoustics Inc. has developed the Sensory Kinetics (SK) Balance System. In the SK system, patients move on a force platform (see Figure 1) while movement and posture data is interpreted by advanced software a mapped to a wearable vibrotactile belt array and visual display. Vibrotactile cueing provides continuous and instantaneous feedback to the patient that compliments their postural and mobility decisions. The investigators believe that vibrotactile feedback can greatly increase spatial awareness and consequently mobility. Further, the ability of the brain to re-organize and relearn functional movement activities provides an intriguing potential pathway for the retention of learned functional mobility strategies.Vibrotactile cueing involves short duration bursts of mechanical vibration from actuators, or tactors, that are mounted within a torso worn belt. The person's position is measured and calculated using a force plate sensor and camera sensors. The computerized system is then used as part of physical therapy balance training to improve the patient's balance and potentially reduce their risk of falling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Vestibular Deficits

Intervention

Device:
• Sensory Kinetics Balance System
Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.

Other:
• Traditional Vestibular Rehabilitation
Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rehabilitation Institute of Chicago	Edward Hines Jr. VA Hospital, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	14 item measure designed to assess static balance and fall risk.	Pre-training,change from baseline to mid training (4 weeks), change from bseline to post training (8 weeks)	Yes
Primary	Functional Gait Assessment (FGA)	Assesses postural stability during walking tasks.	pre-training,change from baseline to mid-training (4 weeks), change from baseline to post-training (8weeks)	Yes
Primary	Modified Clinical Test of Sensory Interaction and Balance (CTSIB)	Assesses balance under a variety of conditions including vision blocked and surface challenges.	pre-training, change from baseline to mid-training (4 weeks) and change from baseline to post-training (8 weeks)	Yes
Secondary	10 meter walk test	assesses walking speed of short duration	Pre-training, mid training (4 weeks), post training (8 weeks)	No
Secondary	Activities-specific and Balance Confidence Scale (ABC):	Subjective measure of confidence in performing various ambulatory activities without falling	Pre-training, mid training (4 weeks), post training (8 weeks)	No
Secondary	Dizziness Handicap Inventory	if dizziness is present: assesses the degree of disability associated with any cause of dizziness.	Pre-training, mid training (4 weeks), post training (8 weeks)	No
Secondary	Six Minute walk test	Assesses distance walked over 6 minutes	Pre-training, mid training (4 weeks), post training (8 weeks)	No