Phase 1
N=124
Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02360488 ↗Enrolled (actual)
124
Serious AEs
5.7%
Results posted
Feb 2020
Primary outcome: Primary: Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy — 7.86; 8.36 units on a scale — p=.96
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Telerehabilitation Therapy (Device); In-Clinic Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy |
7.86; 8.36 | .96 |
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.
Eligibility Criteria
Inclusion criteria
- Age ≥18 years at the time of randomization
- Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset 4-36 weeks prior to randomization
- Arm motor FM score of 22-56 (out of 66) at both the Screening Visit and Baseline Visit
- Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the Screening Visit
- Informed consent signed by the subject
- Behavioral contract signed by the subject
Exclusion criteria
- A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia
- A diagnosis (apart from the index stroke) that substantially affects paretic arm function
- A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
- Severe depression, defined as GDS Score >10
- Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22
- Deficits in communication that interfere with reasonable study participation
- A new symptomatic stroke has occurred since the index stroke that occurred 4-36 weeks prior to randomization
- Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
- Life expectancy < 6 months
- Pregnant
- 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
- Unable to successfully perform all 3 of the rehabilitation exercise test examples
- Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy
- Concurrent enrollment in another investigational study
- Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
- Expectation that subject cannot participate in study visits
- 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.
Data sourced from ClinicalTrials.gov (NCT02360488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.