Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 3 - 18 |
| Updated: | 3/22/2019 |
| Start Date: | March 1, 2016 |
| End Date: | January 2020 |
| Contact: | Jacob R Brodsky, MD |
| Email: | jacob.brodsky@childrens.harvard.edu |
| Phone: | 781-216-2799 |
The investigators aim to compare rehabilitation progress between control patients who will
undergo routine vestibular rehabilitation exercises and experimental patients who will
undergo exercises using a vibrotactile balance belt (Sensory Kinetics Balance Rehabilitation
System) in addition to their routine vestibular rehabilitation regimen during recovery from
diseases affecting the vestibular system. The results of this pilot study will help to
determine if the vibrotactile balance belt is a useful supplement to traditional vestibular
rehabilitation techniques in children suffering from vestibular impairment.
undergo routine vestibular rehabilitation exercises and experimental patients who will
undergo exercises using a vibrotactile balance belt (Sensory Kinetics Balance Rehabilitation
System) in addition to their routine vestibular rehabilitation regimen during recovery from
diseases affecting the vestibular system. The results of this pilot study will help to
determine if the vibrotactile balance belt is a useful supplement to traditional vestibular
rehabilitation techniques in children suffering from vestibular impairment.
The investigators will conduct a randomized pilot trial to examine the efficacy of the
vibrotactile balance belt on vestibular rehabilitation in the pediatric population. All
consented patients will be randomly allocated by a statistician to either the experimental
group where participants will undergo SKBRS exercises in addition to their routine vestibular
rehabilitation regimen, or to the control group where participants will undergo routine
vestibular rehabilitation exercises without the SKBRS.
All subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of
12 sessions). During these sessions, standard balance training exercises will be done at the
discretion of the therapists. Experimental subjects will also undergo 15 minutes of SKBRS
exercises during each standard vestibular rehabilitation session. This device uses
video-based exercises and a non-invasive vibrotactile belt to measure the subject's position
in space and trunk tilt/sway while performing various balance tasks.
All subjects will undergo the following 3 routine tests throughout the course of the therapy
to determine their progress: The Balance Error Scoring System (BESS) to measure the subject's
static balance, the Clinical Test of Sensory Integration and Balance (CTSIB), an office-based
version of the computerized dynamic postuography test, and the Dynamic Gait Index (DGI),
which measures dynamic balance. Finally, the investigators will ask all subjects to provide
their subjective opinion of their vestibular rehabilitation program and their opinion of the
SKBRS by filling out questionnaires.
The primary outcome measure is a comparison of relative balance improvement between subjects
who underwent standard vestibular rehabilitation exercises and those who underwent additional
therapy with the SKBRS during their rehab sessions. This progress will be measured by the
degree of change in the BESS, CTSIB, and DGI scores between subjects' first and final
vestibular rehabilitation sessions. The secondary outcome will be the subjects' subjective
assessments of the effectiveness of their vestibular rehabilitation (measured by the VRBQ) as
well as the experimental subjects' feedback on the SKBRS device (measured by the SKBRS
feedback survey).
vibrotactile balance belt on vestibular rehabilitation in the pediatric population. All
consented patients will be randomly allocated by a statistician to either the experimental
group where participants will undergo SKBRS exercises in addition to their routine vestibular
rehabilitation regimen, or to the control group where participants will undergo routine
vestibular rehabilitation exercises without the SKBRS.
All subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of
12 sessions). During these sessions, standard balance training exercises will be done at the
discretion of the therapists. Experimental subjects will also undergo 15 minutes of SKBRS
exercises during each standard vestibular rehabilitation session. This device uses
video-based exercises and a non-invasive vibrotactile belt to measure the subject's position
in space and trunk tilt/sway while performing various balance tasks.
All subjects will undergo the following 3 routine tests throughout the course of the therapy
to determine their progress: The Balance Error Scoring System (BESS) to measure the subject's
static balance, the Clinical Test of Sensory Integration and Balance (CTSIB), an office-based
version of the computerized dynamic postuography test, and the Dynamic Gait Index (DGI),
which measures dynamic balance. Finally, the investigators will ask all subjects to provide
their subjective opinion of their vestibular rehabilitation program and their opinion of the
SKBRS by filling out questionnaires.
The primary outcome measure is a comparison of relative balance improvement between subjects
who underwent standard vestibular rehabilitation exercises and those who underwent additional
therapy with the SKBRS during their rehab sessions. This progress will be measured by the
degree of change in the BESS, CTSIB, and DGI scores between subjects' first and final
vestibular rehabilitation sessions. The secondary outcome will be the subjects' subjective
assessments of the effectiveness of their vestibular rehabilitation (measured by the VRBQ) as
well as the experimental subjects' feedback on the SKBRS device (measured by the SKBRS
feedback survey).
Inclusion Criteria:
- Referred for vestibular rehabilitation due to balance impairment at Boston Children's
Hospital.
- English speaking
- Understanding of how to use the device
- Intention to complete full 3 months of vestibular rehabilitation
Exclusion Criteria:
- Patients with developmental delay to a degree that prevents them from understanding
how to use the device or that prevents them from being able to provide feedback on
their experience with the device.
- Patients who are unable to stand for the 15 minutes necessary to complete the SKBRS
exercises
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