An interventional study of Telerehabilitation in Stroke, Cerebrovascular Disorders and Brain Diseases, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Home-based Telerehabilitation
Device: 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.
Fugl-Meyer Arm Motor Scale
measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment
Time frame: 90 days
Fugl-Meyer Leg Motor Scale
measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment
Time frame: 90 days
| Milestone | Home-based Telerehabilitation |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment
| units on a scale | Home-based Telerehabilitation |
|---|---|
| Fugl-Meyer Arm Motor Scale | 59 (52.5 to 61.5) |
measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment
| units on a scale | Home-based Telerehabilitation |
|---|---|
| Fugl-Meyer Leg Motor Scale | 28 (27 to 30.5) |
Collected over From enrollment to 90 days later. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home-based Telerehabilitation | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
All patients who signed informed consent.
| Age, Continuous(years) | Home-based Telerehabilitation |
|---|---|
| Median | 61 (52 to 65.5) |
| Sex: Female, Male(Participants) | Home-based Telerehabilitation |
|---|---|
| Female | 4 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Home-based Telerehabilitation |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Home-based Telerehabilitation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Home-based Telerehabilitation |
|---|---|
| United States | 13 |
| Time post-stroke(days) | Home-based Telerehabilitation |
|---|---|
| Median | 129 (52 to 486) |
| Arm motor Fugl-Meyer score(units on a scale) | Home-based Telerehabilitation |
|---|---|
| Median | 46 (42 to 57) |
| Leg motor Fugl-Meyer score(units on a scale) | Home-based Telerehabilitation |
|---|---|
| Median | 28 (23.5 to 29) |
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University of California, Irvine