Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Intervention: Telerehabilitation Therapy; In-Clinic Therapy
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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

          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.