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

Primary Purpose

Vestibular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Rehabilitation/Balance Belt
Standard Vestibular Rehabilitation
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Diseases

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital Waltham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Vestibular Rehabilitation

Vestibular Rehabilitation/Balance Belt

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 4, 2016
Last Updated
April 10, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02722486
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Vestibular Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vestibular Rehabilitation/Balance Belt
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vestibular Rehabilitation/Balance Belt
Other Intervention Name(s)
Sensory Kinetics Balance Rehabilitation System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Vestibular Rehabilitation
Intervention Description
This is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital.
Primary Outcome Measure Information:
Title
Change in BESS Score from baseline to 3 months
Description
The investigators will measure the change in BESS score between the first vestibular rehabilitation session and the last session (3 months later).
Time Frame
0-3 months
Title
Change in CTSIB Score from baseline to 3 months
Description
The investigators will measure the change in CTSIB score between the first vestibular rehabilitation session and the last session (3 months later).
Time Frame
0-3 months
Title
Change in DGI Score from baseline to 3 months
Description
The investigators will measure the change in DGI score between the first vestibular rehabilitation session and the last session (3 months later).
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
Change in subjective symptoms from baseline to 3 months
Description
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.
Time Frame
0-3 months
Title
Sensory Kinetics Balance Rehabilitation System Feedback
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob R Brodsky, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital Waltham
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20588096
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.
Results Reference
background
PubMed Identifier
19345107
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.
Results Reference
background
PubMed Identifier
17271374
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.
Results Reference
background
PubMed Identifier
22255100
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.
Results Reference
background

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

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