Telerehabilitation in the Home After Stroke

About

Brief Summary

The purpose of this research study is to evaluate whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone.

Patients with arm weakness due to stroke that happened in the past 90-150 days will be randomized into one of two groups: [1] TR and usual care; [2] usual care only (no TR), but people in the usual care group will be offered TR once the study is done. TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

Inclusion Criteria:

Age 18-80 years at the time of randomization
The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 120±30 days prior to randomization
The stroke caused upper extremity deficits as defined by Action Research Arm Test score 18-44 (out of 57) at Baseline Visit 1
Box & Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit 1
Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit 1
Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)

Exclusion Criteria:

A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures
Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits
A diagnosis (apart from the index stroke) that substantially affects paretic arm function
Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit 1
Significant cognitive impairment, defined as Montreal Cognitive Assessment score <22 [a lower score is permitted if due to aphasia and allowed by the site PI]
Deficits in communication that interfere with reasonable study participation
Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis
Modified Rankin Scale score was >2 prior to the index stroke
A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke
Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
Life expectancy < 9 months
Pregnant; women of child-bearing potential must have a negative pregnancy test
Botulinum toxin to the paretic arm: received in the prior 3 months OR expected by the 8-Month Visit
Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study
Subject lacks sufficient English or Spanish to comply with study procedures and TR instructions
Expectation that subject will not have a single domicile address during the 6 weeks of therapy that is within 1.5-hr drive of the central study site [this can be waived at the discretion of the site PI]
Contraindication to MRI
On isolation precautions, e.g., due to active COVID-19