Vestibular DiseasesNCT02722486
Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
A study testing Vestibular Rehabilitation/Balance Belt and Standard Vestibular Rehabilitation in people with Vestibular Diseases, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Vestibular Diseases
- What is being tested?
- Vestibular Rehabilitation/Balance Belt and Standard Vestibular Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital Waltham
Waltham, Massachusetts, 02453
About this study
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.
Read the 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).
- Conditions
- Vestibular Diseases
- Being tested
- Vestibular Rehabilitation/Balance Belt, Standard Vestibular Rehabilitation
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation/Balance BeltDevice
Also called Sensory Kinetics Balance Rehabilitation System
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.
Standard Vestibular RehabilitationOther
This is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Vestibular Rehabilitation/Balance Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 0-3 months
Secondary outcomes (2)
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.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion3 Mar 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Brodsky, Boston Children's Hospital
- Investigators
- Jacob R Brodsky, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722486
- Sponsor's protocol ID
- IRB-P00019992
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2016
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20588096Wall 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.
PubMed 19345107Wall 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.
PubMed 17271374Wall 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.
PubMed 22255100
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
- ClinicalTrials.gov ID
- NCT02722486
- Acronym / sponsor ID
- IRB-P00019992
- Conditions
- Vestibular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Vestibular Rehabilitation | Active comparator | Other: Standard Vestibular RehabilitationSubjects 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. |
| Vestibular Rehabilitation/Balance Belt | Experimental | Device: Vestibular Rehabilitation/Balance BeltSubjects 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation/Balance BeltAlso: Sensory Kinetics Balance Rehabilitation SystemWith 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. | Device | Vestibular Rehabilitation/Balance Belt |
| Standard Vestibular RehabilitationThis is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital. | Other | Standard Vestibular Rehabilitation |
Primary outcome
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).
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).
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).
2 secondary outcomes
Change in subjective symptoms from baseline to 3 months
Time frame: 0-3 months
Sensory Kinetics Balance Rehabilitation System Feedback
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Background: PubMed 20588096Wall 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.
- Background: PubMed 19345107Wall 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.
- Background: PubMed 17271374Wall 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.
- Background: PubMed 22255100Wall 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.
- Individual participant dataSharing planned: No
Related trials for Vestibular Diseases
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Recruiting
Human Visual and Vestibular Motion Perception Study
Vestibular Disease
Not yet recruitingObservational study
Prevalence and Diagnosis of Persistent Postural-perceptual Dizziness
Persistent Postural-perceptual Dizziness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob R Brodsky, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation/Balance Belt and Standard Vestibular Rehabilitation in people with Vestibular Diseases, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BESS Score from baseline to 3 months (time frame: 0-3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722486, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.