Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Nervous System Diseases, Stroke, Vascular Diseases
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Arm Motor Scale | 90 days | measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Leg Motor Scale | 90 days | measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Home-based Telerehabilitation |
|---|---|
| Age, Continuous | 61 years |
| Arm motor Fugl-Meyer score | 46 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Leg motor Fugl-Meyer score | 28 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 9 Participants |
| Time post-stroke | 129 days |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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
Population: All patients who signed informed consent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home-based Telerehabilitation | Fugl-Meyer Arm Motor Scale | 59 units on a scale |
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
Population: All patients who signed informed consent
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Home-based Telerehabilitation | Fugl-Meyer Leg Motor Scale | 28 units on a scale |