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

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ClinicalTrials.gov Identifier: NCT02722486
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jacob Brodsky, Boston Children’s Hospital

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 (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.

Condition or disease Intervention/treatment Phase
Vestibular Diseases Device: Vestibular Rehabilitation/Balance Belt Other: Standard Vestibular Rehabilitation Not Applicable

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 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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 Name: Sensory Kinetics Balance Rehabilitation System




Primary Outcome Measures :
  1. Change in BESS Score from baseline to 3 months [ Time Frame: 0-3 months ]
    The investigators will measure the change in BESS score between the first vestibular rehabilitation session and the last session (3 months later).

  2. Change in CTSIB Score from baseline to 3 months [ Time Frame: 0-3 months ]
    The investigators will measure the change in CTSIB score between the first vestibular rehabilitation session and the last session (3 months later).

  3. Change in DGI Score from baseline to 3 months [ Time Frame: 0-3 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 :
  1. Change in subjective symptoms from baseline to 3 months [ Time Frame: 0-3 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.

  2. Sensory Kinetics Balance Rehabilitation System Feedback [ Time Frame: 3 months ]
    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).



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722486


Contacts
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Contact: Jacob R Brodsky, MD 781-216-2799 jacob.brodsky@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Waltham Recruiting
Waltham, Massachusetts, United States, 02453
Contact: Jacob R Brodsky, MD    781-216-2849    jacob.brodsky@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Jacob R Brodsky, MD Boston Children’s Hospital

Publications:
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Responsible Party: Jacob Brodsky, Associate in Otolaryngology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02722486     History of Changes
Other Study ID Numbers: IRB-P00019992
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases