500 Participants Needed

Rehab System for Vestibular Hypofunction

(MINDGAPS Trial)

Recruiting at 1 trial location
BL
AK
Overseen ByAndy Kittelson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Montana
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests the MINDGAPS system, a remote tool to help active-duty and Veteran Service Members with balance and psychological issues after a mild brain injury. It measures balance and visual stability to tailor treatments and track improvements. The goal is to enhance both physical and mental health in this specific group.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Rehab, Vestibular Rehabilitation Therapy, VRT, Balance Rehabilitation Therapy, Balance Retraining Therapy for Vestibular Hypofunction?

Research shows that Vestibular Rehabilitation Therapy (VRT) is effective for improving balance and reducing dizziness in patients with vestibular dysfunction, including the elderly and those with chronic conditions. Studies indicate that VRT can significantly enhance balance performance and reduce self-reported handicaps related to dizziness and imbalance.12345

Is vestibular rehabilitation therapy (VRT) safe for humans?

The research does not specifically mention safety concerns, suggesting that vestibular rehabilitation therapy (VRT) is generally considered safe for humans.12345

How is the treatment for vestibular hypofunction different from other treatments?

Vestibular Rehabilitation Therapy (VRT) is unique because it is an exercise-based program designed to help the brain compensate for inner ear problems, improving balance and reducing dizziness. Unlike medications, which may only mask symptoms, VRT focuses on retraining the brain to adapt to balance issues, making it a more effective long-term solution for many patients.13567

Eligibility Criteria

This trial is for veterans or active duty military members who can stand on their own and consent for themselves. It's not for those currently in physical therapy for balance/dizziness, with recent severe head injuries, blindness, certain eye or neck conditions, history of stroke/neurodegenerative diseases, or brain tumors.

Inclusion Criteria

I am legally able to make my own health decisions.
Veteran or Active Duty Military Service Member
I can stand up on my own.

Exclusion Criteria

I have a spine disorder in my neck.
I have been diagnosed with artery problems in my neck.
Acute head injury within the previous 2 months
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a double-baseline assessment with no intervention

2 weeks
2 visits (in-person)

Treatment

6 weeks of vestibular physical therapy guided by the MINDGAPS system

6 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Rehab
Trial OverviewThe study aims to set norms for inner ear function and psychological health measures and test the MINDGAPS system—a remote monitoring tool during rehab after concussions/mild Traumatic Brain Injury affecting vestibular health.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: RehabExperimental Treatment1 Intervention
6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system
Group II: ObservationalActive Control1 Intervention
Normative data development of performance on vestibular measures following mTBI

Rehab is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Vestibular Rehabilitation Therapy for:
  • Inner ear disorders
  • Concussion and post-concussion syndrome
  • Traumatic brain injury
  • Vestibular migraines
  • Benign paroxysmal positional vertigo (BPPV)
  • Meniere’s disease
  • Persistent postural-perceptual dizziness (PPPD)
🇨🇦
Approved in Canada as Vestibular Rehabilitation Therapy for:
  • Inner ear disorders
  • Concussion and post-concussion syndrome
  • Traumatic brain injury
  • Vestibular migraines
  • Benign paroxysmal positional vertigo (BPPV)
  • Meniere’s disease
  • Persistent postural-perceptual dizziness (PPPD)
🇪🇺
Approved in European Union as Vestibular Rehabilitation Therapy for:
  • Inner ear disorders
  • Concussion and post-concussion syndrome
  • Traumatic brain injury
  • Vestibular migraines
  • Benign paroxysmal positional vertigo (BPPV)
  • Meniere’s disease
  • Persistent postural-perceptual dizziness (PPPD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials
29
Recruited
4,700+

United States Naval Medical Center, San Diego

Collaborator

Trials
110
Recruited
24,200+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Findings from Research

Vestibular rehabilitation therapy (VRT) significantly improved dizziness in elderly patients with chronic vestibular dysfunction, as shown by a notable decrease in dizziness handicap inventory (DHI) scores after 8 weeks of therapy.
In a study of 33 patients over 60 years old, VRT exercises led to marked improvements in balance and function, particularly in those with abnormal canal paralysis, indicating its efficacy as a treatment option.
Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction.Bayat, A., Pourbakht, A., Saki, N., et al.[2022]
In a study of 74 participants with chronic dizziness, those who received expert physiotherapist guidance in a home-based vestibular rehabilitation therapy (VRT) program showed significantly greater improvement in their dizziness scores compared to those who exercised without specific instructions.
Both groups improved over the 8-week study, but the intervention group experienced a more substantial reduction in their Dizziness Handicap Inventory scores, highlighting the importance of tailored instructions for maximizing the effectiveness of home exercise programs.
Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT).Kellerer, S., Amberger, T., Schlick, C., et al.[2023]
Vestibular Rehabilitation Therapy (VRT) is an effective treatment for many patients with vestibular disorders and balance dysfunctions, helping to improve their symptoms.
The paper outlines various assessment methods and treatment strategies for VRT, emphasizing its importance in managing balance-related issues in patients seeking help from otolaryngologists.
Vestibular rehabilitation therapy for the patient with dizziness and balance disorders.Girardi, M., Konrad, HR.[2005]

References

Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. [2022]
Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT). [2023]
Vestibular rehabilitation therapy for the patient with dizziness and balance disorders. [2005]
Relationship between change in balance and self-reported handicap after vestibular rehabilitation therapy. [2019]
Vestibular rehabilitation therapy for the dizzy patient. [2022]
Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. [2022]
The value of close monitoring in vestibular rehabilitation therapy. [2019]