Clinical trial NCT02722486: Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
Official title: Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 (SKBRS - 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.

Detailed description: 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 posturography 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in BESS Score from baseline to 3 months
timeFrame: 0-3 months
measure: Change in CTSIB Score from baseline to 3 months
timeFrame: 0-3 months
measure: Change in DGI Score from baseline to 3 months
timeFrame: 0-3 months
Secondary outcomes:
measure: Change in subjective symptoms from baseline to 3 months
timeFrame: 0-3 months
measure: Sensory Kinetics Balance Rehabilitation System Feedback
timeFrame: 3 months
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston Children's Hospital Waltham
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jacob R Brodsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wall C 3rd. Application of vibrotactile feedback of body motion to improve rehabilitation in individuals with imbalance. J Neurol Phys Ther. 2010 Jun;34(2):98-104. doi: 10.1097/NPT.0b013e3181dde6f0.
citation: Wall C 3rd, Wrisley DM, Statler KD. Vibrotactile tilt feedback improves dynamic gait index: a fall risk indicator in older adults. Gait Posture. 2009 Jul;30(1):16-21. doi: 10.1016/j.gaitpost.2009.02.019. Epub 2009 Apr 2.
citation: Wall C 3rd, Oddsson LE, Horak FB, Wrisley DW, Dozza M. Applications of vibrotactile display of body tilt for rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:4763-5. doi: 10.1109/IEMBS.2004.1404318.
citation: Wall C 3rd, Lyford ND, Sienko KH, Balkwill MD. The design and development of a production prototype balance belt. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3524-8. doi: 10.1109/IEMBS.2011.6090585.