Clinical trial NCT03460587: Long-term Telerehabilitation for Patients With Stroke
Official title: Long-term Telerehabilitation for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 telerehabilitation.

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 platform.

Detailed description: 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 systems.

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.

Eligibility criteria: 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 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 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.

Primary outcomes:
measure: Fugl-Meyer Arm Motor Scale
timeFrame: 90 days
Secondary outcomes:
measure: Fugl-Meyer Leg Motor Scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: UC Irvine
name: Steven Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodakian L, McKenzie AL, Le V, See J, Pearson-Fuhrhop K, Burke Quinlan E, Zhou RJ, Augsberger R, Tran XA, Friedman N, Reinkensmeyer DJ, Cramer SC. A Home-Based Telerehabilitation Program for Patients With Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):923-933. doi: 10.1177/1545968317733818. Epub 2017 Oct 26.
citation: Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.
citation: Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.
citation: Cramer SC, Dodakian L, Le V, McKenzie A, See J, Augsburger R, Zhou RJ, Raefsky SM, Nguyen T, Vanderschelden B, Wong G, Bandak D, Nazarzai L, Dhand A, Scacchi W, Heckhausen J. A Feasibility Study of Expanded Home-Based Telerehabilitation After Stroke. Front Neurol. 2021 Feb 3;11:611453. doi: 10.3389/fneur.2020.611453. eCollection 2020.