A patient's socioeconomic status (SES) should not predict their post-stroke disability but
individuals with low SES are more disabled and have higher mortality rates compared to
individuals with high SES. These inequities are not isolated to low- and middle-income
countries. In the United States, individuals with low SES are more disabled at 3 months and
less likely to be independently ambulatory or discharged to their own homes. There are many
factors contributing to these outcomes; however, one critical feature is access to affordable
care. Many newly developed rehabilitation therapies and technologies require expensive
equipment (e.g. instrumented treadmills, transcranial magnetic stimulation) and extensive
training for clinical staff. The extra costs (financial and training) ensure that these
state-of-the-art options are only available at metropolitan, well-funded institutions or to
individuals who can afford additional healthcare costs. There is an urgent need for
accessible, low-cost solutions capable of being delivered at underfunded hospitals and to
individuals with no or low insurance coverage.
Startle Adjuvant Rehabilitation Therapy (START) represents an accessible and low-cost
solution that can be delivered to rural and socioeconomically disadvantaged populations.
START is the application of a startling, acoustic stimulus alongside traditional therapy.
Distinct from other auditory treatments (e.g. metronome, music), administration of a START
represents an endogenous activation of the brainstem (i.e. reticular formation) a phenomenon
referred to as startReact. Rather than being a standalone treatment, START is adjuvant. An
adjuvant is considered the introduction of an agent (traditionally pharmacological) that
contributes to or enhances an existing medical regimen. Similarly, START is applied within a
standard clinical practice to enhance and accelerate skill re-learning through activation of
the brainstem.
START has been advanced as an adjuvant therapy tool because of the profound way it enhances
training outcomes in individuals with stroke, in particular severe stroke. This is
particularly compelling given the high degree of difficulty in generating functional changes
in individuals with chronic, severe stroke. There is emerging evidence that individuals with
stroke strengthen ipsilateral reticulospinal connections during the process of recovery.
Thus, START may represent a priming of the nervous system to engage the reticular formation,
which is nearly always spared post-stroke, during therapy to enhance both training and
long-term outcomes. Though provocative, there are critical gaps in the literature that are
required before START can be deployed in the clinic. Here, the investigators propose to 1)
perform a rigorous randomized controlled trial during tasks of functional significance (Aim
1), and 2) assess the capacity of START training to generalize to untrained tasks (Aim 2).
Aim 1: Evaluate the capacity of START to enhance training outcomes in individuals with stroke
(iwS). The objective of this aim is to demonstrate that START can enhance tasks of clinical
and functional significance like those performed during therapy. The investigators propose a
randomized, single-blind, parallel, controlled trial evaluating the impact of START on
training outcomes of a functional reaching task in iwS. Hypothesis 1: The rate of learning
and retention will be larger during training with START compared to control (training without
START).
Aim 2: Evaluate the generalizability of START training to untrained tasks. To be viable as an
adjuvant clinical tool to enhance activities of daily living, training benefits attributable
to START must translate beyond the specific tasks trained during therapy. The investigators
propose to evaluate skill transference using sorting and dressing tasks. Hypothesis 2:
Training with START will show higher skill transfer (e.g. time to complete sorting/dressing
task) compared to training without START.
SIGNIFICANCE & IMPACT Imagine the transformative impact of an inexpensive tool that could be
implemented not only in well-funded, metropolitan hospitals but also in small, rural, and
socioeconomically disadvantaged hospitals enhancing recovery for iwS regardless of disability
severity, socioeconomic status, or location. Every year, $43,000,000,000 is paid for care and
therapy of the 7,000,000 stroke survivors living in the US but six months post-stroke 65% of
patients cannot use their impaired hand during activities of daily living (e.g. feeding,
toileting) and 63.5% of stroke survivors will never achieve a total Fugl-Meyer score greater
than 90/226 - i.e. severe disability. These statistics are worse for individuals with low
SES. A recent, 2018 study demonstrated that patients from low SES backgrounds received less
in-patient and out-patient care and were discharged more quickly leading to higher levels of
disability and mortality.
If successful, this study will revolutionize treatment for stroke survivors because START is
non-invasive, inexpensive, and mobile making it accessible to rural and socioeconomically
disadvantaged populations. START's application is a loud, acoustic stimulus timed with
planned motor activity and can be administered via headphones. Unlike many new rehabilitation
devices/techniques, START represents an extremely safe intervention (the application is a
loud sound well beneath OSHA (Occupational Safety and Health Administration) regulations with
no reported adverse reactions since its discovery. Thus, clinical staff training and safety
protocols are minimal further decreasing application costs. Finally, it is mobile and easily
packaged, so it can be administered via the increasing number of telemedicine programs
designed for rural populations. Finally, START allows severe stroke survivors to participate
in and benefit from therapy. The benefits of START are not contained to severe stroke
survivors (e.g. improvement of hand extension in mildly disabled patients) but the capacity
of START to work in severe patients significantly increases the potential of this tool to
assist patients across all levels of disability.