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Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population
N/A
Waitlist Available
Led By Jacob R Brodsky, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a special vibrating belt to help children with balance problems. The belt gives gentle vibrations to guide their movements during exercises. Researchers want to see if this belt helps more than regular balance exercises alone.
Eligible Conditions
- Peripheral Vestibular Disease
- Vestibular Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in BESS Score from baseline to 3 months
Change in CTSIB Score from baseline to 3 months
Change in DGI Score from baseline to 3 months
Secondary study objectives
Change in subjective symptoms from baseline to 3 months
Sensory Kinetics Balance Rehabilitation System Feedback
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vestibular Rehabilitation/Balance BeltExperimental Treatment1 Intervention
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.
Group II: Standard Vestibular RehabilitationActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vestibular Rehabilitation/Balance Belt
2016
N/A
~40
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
788 Previous Clinical Trials
5,582,537 Total Patients Enrolled
Jacob R Brodsky, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
221 Total Patients Enrolled