Open Actively Recruiting

Telerehabilitation In The Home After Stroke

About

Brief Summary

Patients with arm weakness due to stroke that happened in the past 90-270 days will be randomized into one of two groups

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
85 Years

Maximum Age: 85

Inclusion Criteria:

  • Age 18-85 years at the time of randomization
  • The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 90-270 days prior to randomization
  • The stroke caused upper extremity deficits as defined by Action Research Arm Test score 14-44 (out of 57) at Baseline Visit 1

Inclusion Criteria:

  • Age 18-85 years at the time of randomization
  • The index stroke was radiologically verified, due to ischemia or intracerebral hemorrhage (ICH), and had time of onset 90-270 days prior to randomization
  • The stroke caused upper extremity deficits as defined by Action Research Arm Test score 14-44 (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
Study Stats
Protocol No.
24-6224
Category
Brain/Neurological Diseases
Principal Investigator
Steven C. Cramer, MD
Steven C. Cramer, MD
Neurorehabilitation
Steven C. Cramer, MD
Contact
  • Ryan Mccarville
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06682429
For detailed technical eligibility, visit ClinicalTrials.gov.