A Phase 1 interventional study of Telerehabilitation Therapy and In-Clinic Therapy in Stroke, sponsored by University of California, Irvine. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by University of California, Irvine · Phase 1, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 124 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Exclusion criteria
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.**
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.
Device: Telerehabilitation 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.
Behavioral: In-Clinic Therapy
18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.
18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
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
| Milestone | Telerehabilitation Therapy | In-Clinic Therapy |
|---|---|---|
| Started | 62 | 62 |
| Completed | 59 | 55 |
| Not completed | 3 | 7 |
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.
| units on a scale | Telerehabilitation Therapy | In-Clinic Therapy |
|---|---|---|
| Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy | 7.86 ± 6.68 | 8.36 ± 7.04 |
Collected over Baseline to 30 days post-therapy. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telerehabilitation Therapy | 0/62 (0%) | 1/62 (1.6%) | 10/62 (16.1%) |
| In-Clinic Therapy | 0/62 (0%) | 6/62 (9.7%) | 7/62 (11.3%) |
| Event | Telerehabilitation Therapy | In-Clinic Therapy |
|---|---|---|
| DizzinessCardiac disorders | 1/62 | 0/62 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/62 | 1/62 |
| HypertensionCardiac disorders | 0/62 | 1/62 |
| FallEar and labyrinth disorders | 0/62 | 1/62 |
| Limb fractureMusculoskeletal and connective tissue disorders | 0/62 | 1/62 |
| Subdural hemorrhageNervous system disorders | 0/62 | 1/62 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/62 | 1/62 |
| Event | Telerehabilitation Therapy | In-Clinic Therapy |
|---|---|---|
| Arm/shoulder painMusculoskeletal and connective tissue disorders | 10/62 | 4/62 |
| FatigueNervous system disorders | 0/62 | 1/62 |
| FractureMusculoskeletal and connective tissue disorders | 0/62 | 1/62 |
| HypotensionCardiac disorders | 0/62 | 1/62 |
All subjects who were randomized.
| Age, Continuous(years) | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| Mean | 62 ± 14 | 60 ± 13 | 61 ± 14 |
| Sex: Female, Male(Participants) | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| Female | 14 | 20 | 34 |
| Male | 48 | 42 | 90 |
| Ethnicity (NIH/OMB)(Participants) | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 59 | 62 | 121 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 18 | 33 |
| White | 41 | 39 | 80 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| United States | 62 | 62 | 124 |
| Arm motor Fugl-Meyer score(units on a scale) | Telerehabilitation Therapy | In-Clinic Therapy | Total |
|---|---|---|---|
| Mean | 42.8 ± 7.8 | 42.7 ± 8.7 | 42.8 ± 8.3 |
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University of California, Irvine