Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Diseases
• Intervention / Treatment: Other: Standard Vestibular Rehabilitation; Device: Vestibular Rehabilitation/Balance Belt

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).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Boston Children's Hospital Waltham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Vestibular Rehabilitation; Subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of 12 sessions of an hour each). During these sessions, standard balance training exercises will be done at the discretion of the physical therapists.	Other: Standard Vestibular Rehabilitation; This is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital.
Experimental: Vestibular Rehabilitation/Balance Belt; Subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of 12 sessions). They will undergo standard balance training exercises with the physical therapists like the control group, but will also undergo an additional 15 minutes of Balance Belt exercises during each session.	Device: Vestibular Rehabilitation/Balance Belt; With this device, a subject stands on a force platform on the ground, which measures his/her center of pressure. Additionally, there is laptop displaying the video-based exercise programs and a camera that senses the subject's linear sway, roll, and pitch. Information about the subject's position is transmitted via Bluetooth technology to a non-invasive vibrotactile belt which fits comfortably around the subject's waist, over his/her clothing. Using the Sensory Kinetics software, the subject will play a series of games projected on the laptop screen, which prompt him/her to sway in various directions while keeping both feet planted on the force platform.; Other Names: Sensory Kinetics Balance Rehabilitation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BESS Score from baseline to 3 months	The investigators will measure the change in BESS score between the first vestibular rehabilitation session and the last session (3 months later).	0-3 months
Change in CTSIB Score from baseline to 3 months	The investigators will measure the change in CTSIB score between the first vestibular rehabilitation session and the last session (3 months later).	0-3 months
Change in DGI Score from baseline to 3 months	The investigators will measure the change in DGI score between the first vestibular rehabilitation session and the last session (3 months later).	0-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective symptoms from baseline to 3 months	Subjects will fill out validated Vestibular Rehabilitation Benefit Questionnaire before and after 3 months of treatment to determine the change in their subjective dizziness/imbalance symptoms. This will allow the investigators to evaluate the subjective effectiveness of vestibular rehabilitation.	0-3 months
Sensory Kinetics Balance Rehabilitation System Feedback	Experimental subjects will use this questionnaire to give feedback on their experience using the SKBRS. This will be administered on their last visit (3 month point).	3 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Jacob R Brodsky, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: IRB-P00019992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes