N/A
N=19
Telerehabilitation Early After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04657770 ↗Enrolled (actual)
19
Serious AEs
21.1%
Results posted
Apr 2023
Primary outcome: Primary: Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days) — 18.07 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telerehabilitation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days) |
18.07 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Stroke that has been radiologically verified
- Arm motor FM 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
- 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 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
- Expectation that subject will not have a single domicile address during the 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for the telerehab system
Data sourced from ClinicalTrials.gov (NCT04657770). 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.