Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Traditional Balance vs Vibrotactile Feedback Training for Vestibular Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01672658
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Collaborators:
United States Department of Defense
Edward Hines Jr. VA Hospital
Information provided by (Responsible Party):
Arun Jayaraman, Shirley Ryan AbilityLab

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Traumatic Brain Injury
Vestibular Deficits
Interventions Device: Sensory Kinetics Balance System
Other: Traditional Vestibular Rehabilitation
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 16 15
Completed 16 14
Not Completed 0 1
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
<=18 years
1
   6.3%
0
   0.0%
1
   3.3%
Between 18 and 65 years
13
  81.3%
14
 100.0%
27
  90.0%
>=65 years
2
  12.5%
0
   0.0%
2
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
42.5  (16.4) 41.9  (9.6) 42.2  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
5
  31.3%
6
  42.9%
11
  36.7%
Male
11
  68.8%
8
  57.1%
19
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Berg Balance Scale
Hide Description 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.
Time Frame Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: Units on a continuous scale
Pre training 45  (10.94969558) 44  (10.65338)
Mid Training 48  (10.83743512) 47  (10.27212167)
Post Training 50  (8.932851355) 47  (11.25649995)
2.Primary Outcome
Title Functional Gait Assessment (FGA)
Hide Description

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
Time Frame Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-training 15.714  (6.51) 17.125  (5.72)
Mid-training assessment (4 weeks) 18.929  (6.52) 21.21  (6.65)
Post-training (8 weeks) 20.642  (6.52) 23.36  (6.87)
3.Secondary Outcome
Title 10 Meter Walk Test
Hide Description assesses walking speed of short duration
Time Frame Pre-training, mid training (4 weeks), post training (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: m/s
Pre-training 0.873  (0.496) 1.067  (0.532)
Mid-training assessment (4 weeks) 0.944  (0.617) 1.236  (0.632)
Post-training (8 weeks) 1.021  (0.652) 1.253  (0.749)
4.Secondary Outcome
Title Six Minute Walk Test
Hide Description Assesses distance walked over 6 minutes
Time Frame Pre-training, mid training (4 weeks), post training (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: Feet
Pre-training 1021.6  (544.1) 1158.2  (490.5)
Mid-training assessment (4 weeks) 1075.4  (624.1) 1271.1  (566.1)
Post-training (8 weeks) 1165.6  (662.1) 1312.7  (627.5)
5.Secondary Outcome
Title Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed
Hide Description

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

Time Frame Pre-training, mid training, post training
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: sec
Pre-Training 11.18375  (10.15539992) 9.119280952  (7.06647348)
Mid Training 15.98062479  (12.19808074) 16.99357119  (11.85259485)
Post Training 17.986458  (11.13131861) 20.423095  (9.057258643)
6.Secondary Outcome
Title Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open
Hide Description

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

Time Frame Pre-training, mid training (4 weeks), post training (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: sec
Pre-training 21.13041667  (10.59997686) 21.13333333  (10.93591753)
Mid Training 27.039375  (10.71693518) 25.715  (9.43461609)
Post Training 27.467271  (9.635670393) 26.277143  (9.195793711)
7.Secondary Outcome
Title Activities Balance Confidence Scale (ABC)
Hide Description

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

Time Frame Pre-training, mid training, post training
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-training 60.1396875  (23.04021958) 55.53035714  (23.85675041)
Mid Training 71.1828125  (21.01544763) 60.11178571  (20.51856435)
Post Training 72.445313  (22.50808738) 66.151786  (19.0398228)
8.Secondary Outcome
Title Dizziness Handicap Inventory
Hide Description

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)

Time Frame Pre-training, mid training, post training
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pre-training 40.6  (26.87) 40.5  (10.88)
Mid Training 37.0  (28.41) 38.5  (11.47)
Post Training 32.6  (25.58) 26.0  (9.09)
Time Frame [Not Specified]
Adverse Event Reporting Description 0% Indicates that no adverse events were encountered during the study.
 
Arm/Group Title Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Hide Arm/Group Description

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 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.

All-Cause Mortality
Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sensory Kinectics Balance System Traditional Vestibular Rehabilitation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arun Jayaraman, PT, PhD
Organization: Rehabilitation Instititute of Chicago
Phone: 312-238-2091
EMail: a-jayaraman@northwestern.edu
Layout table for additonal information
Responsible Party: Arun Jayaraman, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT01672658     History of Changes
Other Study ID Numbers: NUSTU58913
First Submitted: August 14, 2012
First Posted: August 27, 2012
Results First Submitted: May 22, 2015
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016