Effectiveness of VestAid App

NCT ID: NCT06683417

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-12-30

Brief Summary

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This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.

Detailed Description

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Conditions

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MTBI - Mild Traumatic Brain Injury Vestibular Disease Balance Deficits Vestibular Disorders Dizziness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VestAid

Use of VestAid tablet application to aid vestibular rehabilitation

Group Type EXPERIMENTAL

Vestibular Rehabilitation Aid

Intervention Type DEVICE

The tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI.

Each participant\'s treating physical therapist will develop their own personalized exercise prescription. The physical therapist will be asked to recommend that the patients complete a home exercise program at least 2-3 times per day for 6 weeks. The exercise prescription will be placed on the VestAid by the physical therapist for the patient to follow. The patient is not able to modify the exercise, only the physical therapist can modify the exercises. Exercises will be modified based on patient\'s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\'s symptoms are greater than or equal to 8/10.

Standard of Care vestibular rehabilitation

Use of standard of care vestibular rehabilitation

Group Type ACTIVE_COMPARATOR

Standard of care vestibular rehabilitation

Intervention Type OTHER

Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Interventions

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Vestibular Rehabilitation Aid

The tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI.

Each participant\'s treating physical therapist will develop their own personalized exercise prescription. The physical therapist will be asked to recommend that the patients complete a home exercise program at least 2-3 times per day for 6 weeks. The exercise prescription will be placed on the VestAid by the physical therapist for the patient to follow. The patient is not able to modify the exercise, only the physical therapist can modify the exercises. Exercises will be modified based on patient\'s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\'s symptoms are greater than or equal to 8/10.

Intervention Type DEVICE

Standard of care vestibular rehabilitation

Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades

Intervention Type OTHER

Other Intervention Names

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VestAid

Eligibility Criteria

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Inclusion Criteria

* Snellen visual acuity (corrected) greater than 20/40
* No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz
* Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity
* At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale)
* Internet access at home
* No significant residual from past musculoskeletal or neuromuscular conditions
* Ability ambulates unassisted
* Diagnosed with a concussion or inner ear problem the last 30 days
* Between 18-60 years of age
* Can read and understand English
* Has complaints of dizziness

Exclusion Criteria

* Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem
* No access to internet at home
* Younger than 18 years of age or older than 60 years of age
* Cannot read or understand English
* No complaints of dizziness and/or balance deficits
* Have significant neuropathy
* Cannot see tablet clearly at 1 meter
* Neck pain \>5 on a 10-point pain scale.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

BlueHalo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA

Role: CONTACT

412-383-6642

Chelsea J Manetta, PT, DPT, NCS

Role: CONTACT

4126487964

Facility Contacts

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Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA

Role: primary

412-383-6642

References

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Essery R, Geraghty AW, Kirby S, Yardley L. Predictors of adherence to home-based physical therapies: a systematic review. Disabil Rehabil. 2017 Mar;39(6):519-534. doi: 10.3109/09638288.2016.1153160. Epub 2016 Apr 21.

Reference Type BACKGROUND
PMID: 27097761 (View on PubMed)

Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.

Reference Type BACKGROUND
PMID: 25106780 (View on PubMed)

Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690.

Reference Type BACKGROUND
PMID: 22027077 (View on PubMed)

Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.

Reference Type BACKGROUND
PMID: 7816453 (View on PubMed)

Gottshall K. Vestibular rehabilitation after mild traumatic brain injury with vestibular pathology. NeuroRehabilitation. 2011;29(2):167-71. doi: 10.3233/NRE-2011-0691.

Reference Type BACKGROUND
PMID: 22027078 (View on PubMed)

Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed.

Reference Type BACKGROUND
PMID: 16796772 (View on PubMed)

Other Identifiers

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STUDY24060038

Identifier Type: -

Identifier Source: org_study_id

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