Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300840
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-13
Brief Title:
Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction UVH
Sponsor:
Hanna van Eijsden
Organization:
Gelre Hospitals
Study Overview
Official Title:
Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction a Single-case Experiment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIBE
Brief Summary:
The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance fear of falling fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction
The main questions it aims to answer are does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility fear of falling fatigue and overall functioning does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing
Participants will goes through different phases in an randomized order a baseline phase a sham phase ie wearing the BalanceBelt while it is switched off and an intervention phase ie wearing the BalanceBelt while it is switched on
It is expected that just as with patients with bilateral loss of the balance organ patients with a unilateral loss will also benefit from the BalanceBelt
The main questions it aims to answer are does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility fear of falling fatigue and overall functioning does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing
Participants will goes through different phases in an randomized order a baseline phase a sham phase ie wearing the BalanceBelt while it is switched off and an intervention phase ie wearing the BalanceBelt while it is switched on
It is expected that just as with patients with bilateral loss of the balance organ patients with a unilateral loss will also benefit from the BalanceBelt
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8456207523 | OTHER | METC ISALA | None |