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

Not Applicable

Completed

• Conditions: Vestibular Diseases
• Interventions: Device: Vestibular Rehabilitation/Balance Belt; Other: Standard Vestibular Rehabilitation

• Registration Number: NCT02722486
• Lead Sponsor: 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 (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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-30
• Primary Completion: 2022-03-03
• Study Completion: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular Rehabilitation/Balance Belt	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.
Standard Vestibular Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change in CTSIB Score from baseline to 3 months	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).
Change in DGI Score from baseline to 3 months	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).
Change in BESS Score from baseline to 3 months	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).

Secondary Outcome Measures

Name	Time	Method
Sensory Kinetics Balance Rehabilitation System Feedback	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).
Change in subjective symptoms from baseline to 3 months	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.

Trial Locations

Locations (1)

Boston Children's Hospital Waltham; 🇺🇸 Waltham, Massachusetts, United States