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
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Among 15 studies in Stroke by University of California, Irvine — 1 open to participants now, 2 under way, none of them phase 3. Stroke · University of California, Irvine.
Among the 15 studies in Stroke by University of California, Irvine, this one is the 14th largest by enrollment, is one of 2 that started in 2018, is one of 10 with no phase, and was the 11th registered.
8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →1 of the 15 studies in Stroke by University of California, Irvine is open now, in 1 country. Recruiting first, the newest first:
University of California, Irvine · Sites in United States
Ages 18–84
By country, each count listing its studies:
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 49 across 6,027 interventional studies indexed under Stroke.
Median enrollment 32 across the 15 interventional studies. Of the 12 that completed or were terminated, 10 (83%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Stroke by University of California, Irvine, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2018 to primary completion in Mar 2019, 7 months.
Results were first posted in Dec 2020, 1 year 8 months after primary completion.
Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 7 months is below that.
Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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