Wearable technology to characterize and treat mild traumatic brain injury subtypes: Study protocol for a randomized controlled trial on biofeedback-based precision rehabilitation (SuBTyPE)
Abstract
Background Rehabilitation of persistent imbalance in people with mild traumatic brain injury (mTBI) is challenging, and responsiveness to rehabilitation is often suboptimal. One reason for suboptimal outcomes may be patient heterogeneity within rehabilitation referrals. Specifically, people with greater vestibular and/or ocular-motor (V/O) symptoms may respond better to vestibular rehabilitation therapy (VRT) compared to those with greater mood or cognition symptoms. Poor performance of exercises may also explain suboptimal outcomes. This study aims to 1) assess if a wearable sensor-based multidimensional biofeedback system could enhance rehabilitation, 2) examine responsiveness to rehabilitation depending on the severity of V/O deficits, 3) characterize the impact of V/O deficits on gait and turning during seven days of unsupervised daily living and establish normative mobility data from active-duty service members. Methods This study is a single-blinded randomized controlled trial involving 100 individuals experiencing persistent symptoms from subacute and chronic mTBI. Participants will be randomized into VRT with or without sensor-based biofeedback. Both groups will receive a 6-week VRT. All participants will be tested for balance, gait, turning, and V/O performance before and after VRT. We will compare the efficacy of VRT with or without biofeedback, stratified by the severity of V/O symptoms. Additionally, a subset of 50 participants with mTBI and 40 healthy…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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