Stroke
Conditions
Brief summary
The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.
Detailed description
Substantial evidence indicates that occupational and physical therapy improves outcomes after stroke, and that larger doses are associated with superior outcomes. However, many patients receive suboptimal doses of therapy for reasons that include cost, access, and difficulty with travel. This problem is likely to increase with time given the aging of the population and the increased rate with which patients survive stroke. Telehealth, defined as the delivery of health-related services and information via telecommunication technologies, has enormous potential to address this unmet need. The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke. Telerehabilitation will be evaluated using an assessor-blind, randomized, non-inferiority study design. This study seeks to establish comparable efficacy between the two treatment arms based upon a non-inferiority margin of 2.05 points on the arm motor Fugl-Meyer scale. Key study features include enrollment of a diverse stroke population, standardized and blinded outcomes assessment, a standardized treatment protocol, covariate-adaptive randomization, and use of an active comparator that is matched for duration, frequency, and intensity of therapy. The FDA has determined that this investigation is a non-significant risk device study. A minimum of 5 clinical sites will participate in this study. Each clinical site will conduct all testing and treatment at a single central site, although each clinical site is encouraged to recruit subjects from their referral hospitals. At the central study site, an Assessment Therapist will perform all study testing, blinded to treatment assignment (the subject by necessity is not blinded), while a Treatment Therapist will provide in-clinic therapy as well as direct home-based telerehabilitation. Potential enrollees may be identified through any of several routes, for example, during the acute stroke admission at the clinical site or a referral hospital, during inpatient rehabilitation at the clinical site or a referral hospital, or through other means of community-based recruitment. Study conduct will be highly standardized, including selecting therapy content, delivering therapy, and testing. The current study aims to critically evaluate the utility of a telehealth approach to motor therapy and stroke education. Telehealth has enormous potential to address unmet needs in the growing population of stroke survivors.
Interventions
18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.
BEHAVIORALIn-Clinic Therapy
18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years at the time of randomization 2. Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset 4-36 weeks prior to randomization 3. Arm motor FM score of 22-56 (out of 66) at both the Screening Visit and Baseline Visit 4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the Screening 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 GDS Score \>10 5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score \< 22 6. Deficits in communication that interfere with reasonable study participation 7. A new symptomatic stroke has occurred since the index stroke that occurred 4-36 weeks prior to randomization 8. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye 9. Life expectancy \< 6 months 10. Pregnant 11. 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 the 30 Day Follow Up Visit 12. Unable to successfully perform all 3 of the rehabilitation exercise test examples 13. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy 14. Concurrent enrollment in another investigational study 15. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures 16. Expectation that subject cannot participate in study visits 17. Expectation that subject will not have a single domicile address during the 6 weeks of therapy, within 25 miles of the central study site and with Verizon wireless reception.\*\* * A site may enroll a person who does not meet exclusion criterion # 17 if this is specifically approved by the site's study PI. * Because Montreal Cognitive Assessment scores may be difficult to interpret for patients with aphasia, at the discretion of the site's study PI, exclusion criterion #5 (MoCA score cannot be \<22) can be waived.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy | from the Baseline Visit to the 30 Day Follow Up Visit | The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telerehabilitation Therapy The Telerehabilitation arm of this study 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 half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions. | 62 |
| In-Clinic Therapy The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.
In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions. | 62 |
| Total | 124 |
Baseline characteristics
| Characteristic | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 14 |
| Arm motor Fugl-Meyer score | 42.8 units on a scale STANDARD_DEVIATION 7.8 | 42.7 units on a scale STANDARD_DEVIATION 8.7 | 42.8 units on a scale STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 62 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 18 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 41 Participants | 39 Participants | 80 Participants |
| Region of Enrollment United States | 62 participants | 62 participants | 124 participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 34 Participants |
| Sex: Female, Male Male | 48 Participants | 42 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 10 / 62 | 7 / 62 |
| serious Total, serious adverse events | 1 / 62 | 6 / 62 |
Outcome results
Primary
Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy
The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.
Time frame: from the Baseline Visit to the 30 Day Follow Up Visit
Population: Intention-to-Treat with multiple imputation of missing outcomes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation Therapy | Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy | 7.86 units on a scale | Standard Deviation 6.68 |
| In-Clinic Therapy | Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy | 8.36 units on a scale | Standard Deviation 7.04 |
p-value: 0.9695% CI: [-2.14, 2.26]Regression, Linear