Trial Outcomes & Findings for Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation (NCT NCT01672658)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

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

Results posted on

2016-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Overall Study STARTED	16	15
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	42.5 years STANDARD_DEVIATION 16.4 • n=5 Participants	41.9 years STANDARD_DEVIATION 9.6 • n=7 Participants	42.2 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Berg Balance Scale Post Training	50 Units on a continuous scale Standard Deviation 8.932851355	47 Units on a continuous scale Standard Deviation 11.25649995
Berg Balance Scale Pre training	45 Units on a continuous scale Standard Deviation 10.94969558	44 Units on a continuous scale Standard Deviation 10.65338
Berg Balance Scale Mid Training	48 Units on a continuous scale Standard Deviation 10.83743512	47 Units on a continuous scale Standard Deviation 10.27212167

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Functional Gait Assessment (FGA) Pre-training	15.714 units on a scale Standard Deviation 6.51	17.125 units on a scale Standard Deviation 5.72
Functional Gait Assessment (FGA) Mid-training assessment (4 weeks)	18.929 units on a scale Standard Deviation 6.52	21.21 units on a scale Standard Deviation 6.65
Functional Gait Assessment (FGA) Post-training (8 weeks)	20.642 units on a scale Standard Deviation 6.52	23.36 units on a scale Standard Deviation 6.87

SECONDARY outcome

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

assesses walking speed of short duration

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
10 Meter Walk Test Post-training (8 weeks)	1.021 m/s Standard Deviation 0.652	1.253 m/s Standard Deviation 0.749
10 Meter Walk Test Pre-training	0.873 m/s Standard Deviation 0.496	1.067 m/s Standard Deviation 0.532
10 Meter Walk Test Mid-training assessment (4 weeks)	0.944 m/s Standard Deviation 0.617	1.236 m/s Standard Deviation 0.632

SECONDARY outcome

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

Assesses distance walked over 6 minutes

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Six Minute Walk Test Pre-training	1021.6 Feet Standard Deviation 544.1	1158.2 Feet Standard Deviation 490.5
Six Minute Walk Test Mid-training assessment (4 weeks)	1075.4 Feet Standard Deviation 624.1	1271.1 Feet Standard Deviation 566.1
Six Minute Walk Test Post-training (8 weeks)	1165.6 Feet Standard Deviation 662.1	1312.7 Feet Standard Deviation 627.5

SECONDARY outcome

Timeframe: Pre-training, mid training, post training

Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges. The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts. The scores of the 3 trials are averages

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed Pre-Training	11.18375 sec Standard Deviation 10.15539992	9.119280952 sec Standard Deviation 7.06647348
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed Mid Training	15.98062479 sec Standard Deviation 12.19808074	16.99357119 sec Standard Deviation 11.85259485
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed Post Training	17.986458 sec Standard Deviation 11.13131861	20.423095 sec Standard Deviation 9.057258643

SECONDARY outcome

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

The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions. The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts. The scores of the 3 trials are averages

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open Pre-training	21.13041667 sec Standard Deviation 10.59997686	21.13333333 sec Standard Deviation 10.93591753
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open Mid Training	27.039375 sec Standard Deviation 10.71693518	25.715 sec Standard Deviation 9.43461609
Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open Post Training	27.467271 sec Standard Deviation 9.635670393	26.277143 sec Standard Deviation 9.195793711

SECONDARY outcome

Timeframe: Pre-training, mid training, post training

Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. 16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: "How confident are you that you will not lose your balance or become unsteady when you..." Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=16 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=14 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Activities Balance Confidence Scale (ABC) Post Training	72.445313 units on a scale Standard Deviation 22.50808738	66.151786 units on a scale Standard Deviation 19.0398228
Activities Balance Confidence Scale (ABC) Pre-training	60.1396875 units on a scale Standard Deviation 23.04021958	55.53035714 units on a scale Standard Deviation 23.85675041
Activities Balance Confidence Scale (ABC) Mid Training	71.1828125 units on a scale Standard Deviation 21.01544763	60.11178571 units on a scale Standard Deviation 20.51856435

SECONDARY outcome

Timeframe: Pre-training, mid training, post training

Population: This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.

A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness. Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)

Outcome measures

Outcome measures
Measure	Sensory Kinectics Balance System n=10 Participants 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. Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.	Traditional Vestibular Rehabilitation n=4 Participants 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. Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
Dizziness Handicap Inventory Pre-training	40.6 Units on a scale Standard Deviation 26.87	40.5 Units on a scale Standard Deviation 10.88
Dizziness Handicap Inventory Mid Training	37.0 Units on a scale Standard Deviation 28.41	38.5 Units on a scale Standard Deviation 11.47
Dizziness Handicap Inventory Post Training	32.6 Units on a scale Standard Deviation 25.58	26.0 Units on a scale Standard Deviation 9.09

Adverse Events

Sensory Kinectics Balance System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Vestibular Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arun Jayaraman, PT, PhD

Rehabilitation Instititute of Chicago

Phone: 312-238-2091

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place