Health TrialsbyHealthPanel

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

ConditionsMild Traumatic Brain InjuryDizziness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMountain Home Research & Education Corporation

About this trial

The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks.

Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years of age,

diagnosis of mTBI,

documented dizziness (total DHI score ≥ 16) and/or imbalance (total functional gait assessment score < 23/30 or < age-referenced norms)

Disqualifiers

severe neurological disease (e.g., Parkinson's disease, neuropathy),

moderate to severe cognitive impairment (< 23/30 on the Montreal Cognitive Assessment),

significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),

vision impairment (best-corrected visual acuity worse than 20/40 in the better eye), and

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vestibular Rehabilitation Therapy (VRT)

    Behavioral

    customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Standard VRTActive comparator 1 intervention
Group B: Digital VRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12

The DHI is a self-report scale of the impact of dizziness on activities (Jacobson \& Newman, 1990). Total scores range from 0 (no handicap) to 100 (severe handicap).

Time frame
baseline, week 4, week 12

Secondary outcomes

1

Change from baseline in modified Clinical Test of Sensory Interaction and Balance (mCTSIB) at week 4

The mCTSIB assesses sensory integration by measuring postural stability under conditions in which visual and somatosensory feedback is altered. The test is organized into a series of four conditions of increasing difficulty. The first two conditions are performed on a firm surface with eyes open and eyes closed. The final two conditions are performed on a foam surface with eyes open and closed. The maximum duration of each trial is 30 seconds. The total score is the sum of the four conditions with a maximum total of 120 seconds.

Time frame
baseline, week 4
2

Change from baseline in Functional Gait Assessment (FGA) at week 4

The FGA tests dynamic gait. The FGA is a 10-item test that incorporates more difficult gait items, e.g., head turns, narrow base of support, backwards, and with eyes closed (Wrisley et al., 2004). Total FGA scores \< 23/30 indicate high fall risk and there are age-referenced norms for comparison (Walker et al., 2007).

Time frame
baseline, week 4
3

Change from baseline in 10 Meter Walk Test (10MWT) at week 4

The (10MWT) will be used to assess preferred gait speed (Bohannon \& Williams, 2011). Participants will walk at their normal pace on a level, 10-meter walkway. The dependent variable is preferred gait speed (m/s).

Time frame
baseline, week 4
4

Change from baseline in Visual Analogue Scales (VAS) at week 4

The VAS quantifies the impact of dizziness on activities. Participants place a mark on a 10-cm horizontal line with 20% increments indicated (0-100%; Hall \& Herdman, 2006). Patients indicate the percent of time that dizziness interferes with activities.

Time frame
baseline, week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mountain Home Research & Education Corporation

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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