Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format

This is a longitudinal, single blind, randomized controlled trial with three parallel 6 week
intervention arms that will be conducted over a three-year time period. After obtaining
informed consent, and completing baseline testing, participants will be randomized to one of
three study arms: 1) Home-based BATRAC Telerehab (HBT) + TTT, 2) Lab-based BATRAC (LBB) +
TTT, and 3) Delayed Entry Usual Care. This delayed entry group will serve as a control for
the initial six weeks of enrollment and NOT receive an active study intervention before
randomizing to one of the two active interventions. Weekly phone calls will be conducted
during this control period to record general activity (household or community) and monitor
amount and intensity of arm use.

Participants will complete Home-based BATRAC training or Lab-based BATRAC training three
times a week for 6-9 weeks for a total of 18 training sessions. Participants will then be
asked to return for a follow-up after 8 weeks of no training. A study evaluator blinded to
the intervention assignment will complete all outcome measures at baseline, training
completion, and at the 8 week retention follow-up. The participants in the Home-based BATRAC
telerehabilitation group will be given a VA's MyHealtheVet (www.myhealth.va.gov) website
account for asynchronous communication with the therapist and to access the educational
features and resources about stroke, exercise and caregiver support. The interventions are as
described below.

1. Home-based BATRAC telerehabilitation: The BATRAC training platform will be used in
conjunction with the VA MyHealtheVet website. This group will have a MyHealtheVet
account to access the Secure Messaging Option for VA approved electronic messaging to
the study therapist. The MyHealtheVet will provide asynchronous communication with the
study therapist, and will store performance information entered by the participant and
caregiver related to arm exercise duration, repetitions completed and distances reached.
This account can be securely linked and is VA approved for use on any home device
(computer, cell phone or tablet) with internet. MyHealtheVet training will be completed
at the VA and at a one-time home visit with the participant and their identified
caregiver to verify access, and use.

BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest
periods (see Lab-based BATRAC training details below) followed by 15 minutes of video
guided Transition to Task Training (TTT). These videos will be linked from the VA
MyHealtheVet site to study specific Youtube videos demonstrating the exercise. The
initial training will occur in the lab setting with the therapist for BATRAC instruction
and TTT exercise training. The participant and caregiver will have the opportunity ask
questions and develop proficiency during this training session. For the TTT, each
functional task will be presented via the MyHealtheVet Secure Messaging (SM) and linked
by a URL to an instructive Youtube video clip of exercise sequencing, and level of
difficulty. After completion of each exercise session the participant will complete a
study report form attached to the SM. This information will be available for off-line
assessment of performance by the research therapist. In cases of participant
non-adherence, the therapist can contact the participant via phone to review exercise
barriers and motivate the individual to participate. If necessary, the therapist could
change the exercise parameters and send changes within the My HealtheVet SM. A video of
the training set-up will be completed at the VA at the start and at the end of the
intervention to monitor adherence and consistency with the TTT activities.

2. Lab-based BATRAC + TTT training: Participants randomized to this group will receive 60
minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). The
BATRAC training consists of high intensity bilateral reaching and retrieving (pushing
handles away and pulling them back) on a constrained linear track to promote maximum arm
extension. The track can be set at different angles in the work space. The training
protocol is the same for both groups and will consist of four, 5-minute periods
interspersed with 5-minute rest periods to avoid fatigue. An auditory metronome is set
initially at the participant's preferred speed and for periods 1 and 3 participants move
both arms simultaneously (in-phase). In periods 2 and 4 participants move both arms in
alternating (antiphase) movements. A fifth bout of simultaneous arm movements will be
included to reach the 45 minute training goal. Progression of the auditory cue
frequency, direction of travel (pushing/pulling or in a diagonal) and distance of reach
will be progressed every 3 sessions based on performance. If a progression cannot be
sustained for the five-minute bouts by the end of the session, adjustments towards the
previous level are made. This training will be followed by 15 minutes of transition to
task training (TTT) as described below with supervision and support as needed by the
therapist.

Transition to Task Training (TTT): Each participant will receive 45 minutes of their
randomized BATRAC intervention followed by 15 minutes of TTT. This training is
functionally based in four domains of real-world tasks: homemaking, hygiene, feeding,
and dressing. Two goal directed functional tasks are selected from the four domains
every two weeks and prescribed to the individual based on severity level, general
interests and goal. The task design is progressive in nature and difficulty is added by
changing the parameters (movement amplitude) and demand (resistance) for increased
generalization to real life challenges. Assist by the therapist or caregiver is provided
to prevent compensatory movements from being re-enforced. For the home-based training,
the caregiver will be instructed to provide this assistance through the initial personal
training as well as have access to a set of videos for each of the tasks.

3. Delayed Entry Usual Care: Participants randomized to this group will initially serve as
a control and not receive any study interventions except for the protocol study
evaluations in the same time intervals as those receiving active interventions and
weekly phone calls to record general activity level. After serving as a control, this
group will be entered into their delayed active intervention group of either lab-based
BATRAC + TTT training, or Lab-based Robot+ TTT.

Inclusion Criteria:

- Age 18 years or older

- Have a clinically defined unilateral hemiparetic stroke with radiologic exclusion of
other diagnosis

- Stroke onset of at least 6 months prior to enrollment

- Present with moderate to severe arm impairment based on a Fugl-Meyer score ranging
from 19-50 out of 66

- No previous experience using the BATRAC

- Ability to use and interact with the tele-rehabilitation platform according to study
protocol

- Have an identified individual/caregiver to perform the TTT exercises if randomized to
the Home Telerehabilitation group

Exclusion Criteria:

- Musculoskeletal diagnosis or significant arm pain that would interfere with
positioning and use of the intervention (BATRAC) devices

- Cognitive impairment such that the participant is unable to understand the study
requirements to answer the Evaluation to Sign Consent Form tool accurately

- Absence of a working telephone line or cell phone for telerehabilitation set-up if
randomized to this group

- Enrollment in a concurrent rehabilitation study or actively receiving therapy for
their stroke affected (study) arm

- Having received a botulinum toxin injection to the stroke affected (study) arm within
3 months of enrollment