Self Directed Stations for the Stroke Patient

1 BACKGROUND AND RATIONALE

1.1 Background

Due to the high incidence of stroke, increased risk of developing secondary (e.g., pain,
depression, urinary tract infections, pressure ulcers, falls, and seizures) and chronic
conditions (e.g., second stroke, CVD), high medical costs 1, evolving healthcare system
(e.g., reimbursement, length of stay, staffing productivity 2, healthcare professionals are
challenged to explore and develop innovative strategies to continue to achieve the best
clinical practice and outcomes for patients. Functional activity levels are typically low
during inpatient rehabilitation post stroke 3-6, emphasized by King and colleagues 7 who
reported that patients post stroke undergoing inpatient rehabilitation spent 76% of their day
in their bedroom and 62% being inactive. Consequently, since dose of functional activity
(amount of active time and/or quantity of repetitions) is posited to relate to outcomes 8-11,
the optimal conditions for inpatient rehabilitation are being questioned. The literature is
clear that low functional activity reflects low potential for neuroplasticity. Consequently,
novel and feasible methods to provide higher doses of functional activity during inpatient
rehabilitation, that realistically considers cost-effectiveness and resource allocation 12,
are important to improve functional outcomes post stroke 13.

1.2 Rationale for Protocol

Early initiation of therapy post stroke has been associated with improved long-term outcomes
14, and functional activity dose (e.g., activity time, number of repetitions) during the
first week of inpatient rehabilitation predicts both gait velocity at discharge and length of
time to independent walking 15. Specifically, patients who completed more than the median
number of exercise repetitions (703) during the first week of inpatient rehabilitation
experienced quicker recovery of unassisted walking 15. This lack of activity is a significant
issue during inpatient rehabilitation and for overall recovery as repetitive task practice is
argued to drive neural plasticity following stroke 16,17. Specifically, there is a growing
body of evidence indicating that increased functional activity and large volume of practice
during inpatient rehabilitation is required to induce improved stretch reflex modulation and
increased neuromuscular activation 11, thus leading to meaningful neural adaptations and
recovery following stroke 16. However, our current clinical practice of 3-hours of therapy
during inpatient rehabilitation (which is standard of care for inpatient rehabilitation
hospitals) may not be adequate to facilitate neuroplasticity and achieve optimal functional
outcomes 10. This is emphasized by the fact that Medicare beneficiaries with stroke
undergoing inpatient rehabilitation experienced shorter LOS, had worsening admission and
discharge function, and had fewer community discharges 18. Therefore, our objective in this
proposal is to evaluate the feasibility and effectiveness of implementing a novel
intervention to facilitate patient-directed activity for individuals undergoing inpatient
rehabilitation. The goal of the intervention is to increase repetition, stimulation,
attention, and therapeutic activity of the affected extremities and trunk to facilitate
improved outcomes following stroke 17,19,20. This will be achieved by adding up to 1.5-hours
of daily patient-directed activities into the individuals schedule beyond the 3-hours of
therapy provided by clinicians, thus increasing daily therapeutic activity time by up to 50%.
The activities will include physical (PT) and occupational therapy (OT) tasks (see table 1
below for more details). The activities are therapeutic in nature, include typical activities
that patients would complete during the 3-hours of therapy provided as standard of care, are
low intensity, and include activities that involve being seated or prone on a gym mat.

It is important to note that the clinical team at Baylor Institute for Rehabilitation has
been implementing up to 1.5-hours of additional daily therapy into standard of care since
January 2014. However, to date we have not collected any effectiveness data so the clinical
and research team wanted to demonstrate through a research project that the addition of the
extra 1.5-hours of daily therapy is beneficial beyond the 3-hours of therapy currently
provided as standard of care. Since starting the additional therapy in January 2014 the
clinical team has had 25 patients successfully move through rehabilitation and no patients
have had any adverse events.

2.1 Primary Objectives

Pilot the feasibility of integrating the novel patient-directed activity program into
inpatient rehabilitation following stroke. Based on guidelines for conducting an a priori
pilot study we will assess aspects of the process (e.g., eligibility, randomization),
resources (e.g., equipment, space), management (e.g., staff capacity for data entry and
management), and scientific basis (e.g., sensitive outcome measures) of the intervention. Our
working hypothesis is that that the patient-directed activity program will be successfully
integrated into patient and clinical schedule.

2.2 Secondary Objectives

To identify if participation in the novel patient-directed activity program improves
functional ability and health related quality of life (HRQOL) in patients post stroke. Our
working hypothesis is that patients' post stroke that actively participate in the program
will manifest significant increases in functional ability and HRQOL at discharge to inpatient
rehabilitation and at the follow-up appointment within 6 months of discharge when compared to
controls.

3 INVESTIGATIONAL PLAN

3.1 Study Design

We will use a randomized controlled trial and include stroke patients who are undergoing
inpatient rehabilitation at Baylor Institute for Rehabilitation (BIR). Participants will be
randomized into an experimental (patient-directed station program) or control group (standard
of care).

Inclusion Criteria:

- 18 years of age and older

- Safe to be left unsupervised as deemed by therapist or has caregiver present

- Diagnosed with stroke in past six months

- Medically stable as deemed by therapy team

- >3 on FIM comprehension

- Primary diagnosis of stroke (all types)

Exclusion Criteria:

- Pre-morbid developmental disability

- Significant pre-morbid psychological diagnosis or concurrent TBI

- Other cognitive impairment that would prevent participation as determined by the
clinician