Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

Substantial evidence indicates that occupational and physical therapy improves outcomes after
stroke, and that larger doses are associated with superior outcomes. However, many patients
receive suboptimal doses of therapy for reasons that include cost, access, and difficulty
with travel. This problem is likely to increase with time given the aging of the population
and the increased rate with which patients survive stroke. Telehealth, defined as the
delivery of health-related services and information via telecommunication technologies, has
enormous potential to address this unmet need.

The current study will test the effectiveness of a novel home-based telehealth system
designed to improve motor recovery and patient education after stroke. A total of 124
subjects (the number may be larger depending on the rate of subject dropout) with arm motor
deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be
randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic
setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the
subject's home via an internet-connected computer). The intensity, duration, and frequency of
this therapy will be identical across the two groups, with subjects in both treatment arms
receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10
minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor
Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is
the focus here because it is commonly affected by stroke, is of central importance to many
human functions, and is strongly linked to disability and well being after stroke.

Telerehabilitation will be evaluated using an assessor-blind, randomized, non-inferiority
study design. This study seeks to establish comparable efficacy between the two treatment
arms based upon a non-inferiority margin of 2.05 points on the arm motor Fugl-Meyer scale.
Key study features include enrollment of a diverse stroke population, standardized and
blinded outcomes assessment, a standardized treatment protocol, covariate-adaptive
randomization, and use of an active comparator that is matched for duration, frequency, and
intensity of therapy. The FDA has determined that this investigation is a non-significant
risk device study.

A minimum of 5 clinical sites will participate in this study. Each clinical site will conduct
all testing and treatment at a single central site, although each clinical site is encouraged
to recruit subjects from their referral hospitals. At the central study site, an Assessment
Therapist will perform all study testing, blinded to treatment assignment (the subject by
necessity is not blinded), while a Treatment Therapist will provide in-clinic therapy as well
as direct home-based telerehabilitation. Potential enrollees may be identified through any of
several routes, for example, during the acute stroke admission at the clinical site or a
referral hospital, during inpatient rehabilitation at the clinical site or a referral
hospital, or through other means of community-based recruitment. Study conduct will be highly
standardized, including selecting therapy content, delivering therapy, and testing.

The current study aims to critically evaluate the utility of a telehealth approach to motor
therapy and stroke education. Telehealth has enormous potential to address unmet needs in the
growing population of stroke survivors.

Inclusion criteria

1. Age ≥18 years at the time of randomization

2. Stroke that is radiologically verified, due to ischemia or to intracerebral
hemorrhage, and with time of stroke onset 4-36 weeks prior to randomization

3. Arm motor FM score of 22-56 (out of 66) at both the Screening Visit and Baseline Visit

4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the
Screening Visit

5. Informed consent signed by the subject

6. Behavioral contract signed by the subject

Exclusion criteria

1. A major, active, coexistent neurological or psychiatric disease, including alcoholism
or dementia

2. A diagnosis (apart from the index stroke) that substantially affects paretic arm
function

3. A major medical disorder that substantially reduces the likelihood that a subject will
be able to comply with all study procedures

4. Severe depression, defined as GDS Score >10

5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22

6. Deficits in communication that interfere with reasonable study participation

7. A new symptomatic stroke has occurred since the index stroke that occurred 4-36 weeks
prior to randomization

8. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least
one eye

9. Life expectancy < 6 months

10. Pregnant

11. Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation
that Botox will be administered to the arm, leg, or trunk prior to completion of the
30 Day Follow Up Visit

12. Unable to successfully perform all 3 of the rehabilitation exercise test examples

13. Unable or unwilling to perform study procedures/therapy, or expectation of
non-compliance with study procedures/therapy

14. Concurrent enrollment in another investigational study

15. Non-English speaking, such that subject does not speak sufficient English to comply
with study procedures

16. Expectation that subject cannot participate in study visits

17. Expectation that subject will not have a single domicile address during the 6 weeks of
therapy, within 25 miles of the central study site and with Verizon wireless
reception.**

- A site may enroll a person who does not meet exclusion criterion # 17 if this is
specifically approved by the site's study PI.

- Because Montreal Cognitive Assessment scores may be difficult to interpret for
patients with aphasia, at the discretion of the site's study PI, exclusion
criterion #5 ("MoCA score cannot be <22") can be waived.