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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Telerehabilitation | Experimental | Home-based Telerehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Device | The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Arm Motor Scale | measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Leg Motor Scale | measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Cramer, MD | UC Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29072556 | Background | 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. | |
| 21482550 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home-based Telerehabilitation | Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients who signed informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-based Telerehabilitation | Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer Arm Motor Scale | measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment | All patients who signed informed consent. | Posted | Median | Inter-Quartile Range | units on a scale | 90 days |
|
From enrollment to 90 days later
All adverse events and serious adverse events were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home-based Telerehabilitation | Home-based Telerehabilitation Telerehabilitation: The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven C. Cramer, MD | UCLA | 424-522-7273 | sccramer@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2020 | Nov 22, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2020 | Nov 22, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| 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. |
| 10421300 | Background | 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. |
| 33613417 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Time post-stroke | Median | Inter-Quartile Range | days |
|
| Arm motor Fugl-Meyer score | Median | Inter-Quartile Range | units on a scale |
|
| Leg motor Fugl-Meyer score | Median | Inter-Quartile Range | units on a scale |
|
|
|
| Secondary | Fugl-Meyer Leg Motor Scale | measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment | All patients who signed informed consent | Posted | Median | Inter-Quartile Range | units on a scale | 90 days |
|
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| 0 |
| 13 |
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| 13 |
| 0 |
| 13 |
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| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |