Skip to main content
Clinical Trials/NCT04657770
NCT04657770
Completed
Not Applicable

Telerehabilitation Early After Stroke

University of California, Los Angeles2 sites in 1 country19 target enrollmentMay 13, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of California, Los Angeles
Enrollment
19
Locations
2
Primary Endpoint
Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this research study is to assess the feasibility of initiating telerehab in early stages after stroke during patient admission to an inpatient rehabilitation facility. Patients will complete 36 sessions of telerehab 6 days/week up to 8 weeks with a telehealth system provided in their hospital room and at their home. The system will include rehabilitation activities/exercises, education, and assessments to evaluate the patient experience and measure patient outcomes at the end of a 6-week course of telerehab.

Detailed Description

Stroke is a major cause of disability. Loss of movement is a major part of this. Studies show that high doses of rehabilitation therapy can reduce disability, but many patients do not receive this, e.g., due to obstacles such as difficulty accessing care. The research team has previously found that telerehabilitation is an effective way to deliver care and improve outcomes. These prior studies were performed after hospital discharge, when patients were already back at home. The current study aims to extend this work by introducing telerehabilitation to the bedside of patients admitted to an inpatient rehabilitation facility. In this study, key areas of interest include issues related to, and the clinical effects of, telerehabilitation that is started during the rehab admission and is continued after discharge in the patient's home.

Registry
clinicaltrials.gov
Start Date
May 13, 2021
End Date
June 22, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven C. Cramer, MD, FAAN, FAHA

Professor

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Stroke that has been radiologically verified
  • Arm motor FM score \<56 (out of 66) at initial visit
  • Box \& Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit
  • Informed consent and behavioral contract signed by the subject
  • Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation

Exclusion Criteria

  • A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
  • A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
  • Severe depression, as defined as Geriatric Depression Scale Score \>10 at initial visit
  • Significant cognitive impairment, as defined as Montreal Cognitive Assessment score \<22 (lower score permitted if due to aphasia with approval from Dr. Cramer)
  • Deficits in communication that interfere with reasonable study participation
  • Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
  • Life expectancy \<6 months
  • 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 within 3 months of study enrollment
  • Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
  • Non-English speaking, such that subject does not speak sufficient English to comply with study procedures

Outcomes

Primary Outcomes

Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days)

Time Frame: 60 days

Measure of arm impairment. Scores range from 0-66, with higher numbers reflecting less arm impairment. We will be measuring change in scores from baseline to end of treatment (60 days).

Study Sites (2)

Loading locations...

Similar Trials