Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)

NCT06300840 | Not Yet Recruiting DMC

• 2 other identifiers: 2023_49NL84562.075.23
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., 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.

Conditions

Vestibular Disorder

Keywords

vibrotactile feedback

Outcome Measures

Primary Outcomes (1)

• Mobility and Balance Score (MBS)

  The MBS is a rating given by the patient on a scale ranging from 0 to 10, as a subjective grading of his or her overall mobility and balance in daily life. Where a higher score means a better score.

  Daily for 7 weeks

Secondary Outcomes (12)

• General functioning

  Daily for 7 weeks

• physical activity_NRS

  Daily for 7 weeks

• physical activity_steps

  Daily for 7 weeks

• Fear of falling

  Daily for 7 weeks

• fatigue

  Daily for 7 weeks

Other Outcomes (7)

• age

  Baseline

• time since onset of the vestibular hypofunction

  Baseline

• cause of vestibular hypofunction

  Baseline

Study Arms (3)

Baseline

NO INTERVENTION

Wearing no Balancebelt.

Sham condition

SHAM COMPARATOR

Wearing the BalanceBelt while it is switched off

Device: BalanceBelt

Intervention

EXPERIMENTAL

Wearing the BalanceBelt while it is switched on

Device: BalanceBelt

Interventions

BalanceBelt DEVICE

The vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback).

Intervention; Sham condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with severe unilateral vestibular dysfunction (i.e., a gain below 0.6 of the affected side and a gain between 0.8 and 1.1 of the contralateral side measured by the video-Head Impulse Test (vHIIT)).
• Duration of dizziness complaints \>3 months (i.e. chronic dizziness).
• Self-reported imbalance with a fear of falling and/or actual falls.
• Is able to walk (with or without a walking aid).
• Self-reported overall Mobility and Balance Score (MBS) of 3-5 points
• Motivated to try the BalanceBelt.
• Provides written informed consent.

You may not qualify if:

• Age \< 18 years
• Presence of neurological, psychiatric or orthopaedic disorders, Persistent postural-perceptual dizziness (PPPD), reduced proprioceptive sensitivity or impaired vision which influences the postural stability.
• Not able to understand instructions and questionnaires in Dutch
• Not able/willing to visit Gelre Hospital Apeldoorn for necessary visits.
• Wheelchair bound at home

Sponsors & Collaborators

• Hanna van Eijsden: lead

Study Sites (1)

Gelre Hospitals

Apeldoorn, Gelderland, 7334 DZ, Netherlands

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Tjasse Bruintjes, PhD

  Gelre Hop

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Koppelaar - van Eijsden, MSc

CONTACT

+31555818470; h.van.eijsden@gelre.nl

Tjard Schermer, PhD

CONTACT

t.schermer@gelre.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data-analyst and test-observer are masked
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical investigator

Model Details: Single-case-experiment (SCE) with a reversal design and with randomization of phases.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)