NCT02722486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

March 4, 2016

Last Update Submit

April 10, 2023

Conditions

Vestibular Diseases

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in subjective symptoms from baseline to 3 months

    0-3 months

  • Sensory Kinetics Balance Rehabilitation System Feedback

    3 months

Study Arms (2)

Standard Vestibular Rehabilitation

ACTIVE COMPARATOR

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

Vestibular Rehabilitation/Balance Belt

EXPERIMENTAL

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

Interventions

Vestibular Rehabilitation/Balance BeltDEVICE

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.

Also known as: Sensory Kinetics Balance Rehabilitation System
Vestibular Rehabilitation/Balance Belt
Standard Vestibular RehabilitationOTHER

This is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital.

Standard Vestibular Rehabilitation

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital Waltham

Waltham, Massachusetts, 02453, United States

Location

Related Publications (4)

  • 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.

    PMID: 20588096BACKGROUND

  • 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.

    PMID: 19345107BACKGROUND

  • 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.

    PMID: 17271374BACKGROUND

  • 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.

    PMID: 22255100BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jacob R Brodsky, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate in Otolaryngology

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 30, 2016

Study Start

March 1, 2016

Primary Completion

March 3, 2022

Study Completion

January 1, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)