Long-term Telerehabilitation for Patients With Stroke

Conditions:Peripheral Vascular Disease, Cardiology, Neurology, Neurology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Age Range:18 - Any
Start Date:August 29, 2018
End Date:March 31, 2019
Contact:Lucy Dodakian, MA

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The aim of the current protocol is to study 40 patients, each for 12 weeks, to address
hypotheses related to the ability of a telerehabilitation system to (a) improve motor status
and disability, (b) collect various forms of patient data from the home, (c) improve risk
factor knowledge and control, and (d) assess patient compliance with home-based

Patients who have returned to their home after stroke will be provided with a telehealth
system and be asked to use it 6 days/week for 12 weeks, during which time subjects will use
this system for daily rehabilitation therapy, assessments, and education--all on one

Stroke is perennially one of the leading causes of human disability. Stroke is truly a
chronic disease, with survivors living for years or decades after the event. Increasing
evidence describes years of steady decline in several health measures for stroke survivors.
Many factors contribute to this, including further strokes, uncontrolled risk factors,
development of late complications of stroke, and limited access to rehabilitation therapy.

New approaches are needed that address the many needs of stroke survivors, efficiently and in
aggregate. Emerging telehealth technologies have high potential to address this major unmet
need, but substantial innovation will be needed. The long-term goal is to establish a
telehealth platform to treat chronic stroke.

A telehealth system will be delivered to enrollee's home. Patients will be asked to interact
with their system daily (at least 6 days/wk) for 12 weeks. For 3 times per week, during the
first 2 weeks, and then 1 time per week thereafter, a study therapist or research assistant
in the lab will use the telehealth system to have a videoconference with the subject, to
answer questions, provide feedback, review progress, and make any changes needed in the
therapy plan. Study personnel will monitor usage statistics and performance measures for all

A key strategy is to measure in parallel, patient behaviors in three categories of health
issues central to chronic stroke: (1) medical management issues including risk factor
knowledge and control, (2) disability issues including motor function, and (3) psychological
issues including depression and anxiety.

Inclusion Criteria:

1. Age ≥18 years at the time of randomization

2. Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage
or subarachnoid hemorrhage, and with any time of stroke onset prior to randomization

3. Arm motor Fugl Meyer score of 28-66; if Arm motor Fugl Meyer score> 59, must also have
Box & Blocks on affected side >25% lower

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

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 Geriatric Depression Scale Score >11

5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22;
note that this exclusion criteria can be waived at the discretion of the study PI,
e.g., for aphasia

6. Deficits in communication that interfere with reasonable study participation

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

8. Life expectancy < 6 months

9. 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
participation in this study

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

11. Unable or unwilling to perform study procedures/therapy, or expectation of
non-compliance with study procedures/therapy, or expectation that subject will be
unable to participate in study visits

12. Concurrent enrollment in another investigational study

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

14. Expectation that subject will not have a single domicile address during the 12 weeks
of therapy, within 75 miles of the central study site

15. Note that the presence of wireless home internet connectivity is not an exclusion
criterion, but preference may be given to enrollees who do have wireless home internet
connectivity because this will enable testing of study hypotheses.
We found this trial at
Irvine, California 92697
Phone: 949-824-8748
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
Irvine, CA
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