Telerehabilitation + Sinemet for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
California Rehabilitation Institute, Los Angeles, CA
Stroke
Telerehabilitation - Device
Eligibility
18+
All Sexes
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Study Summary

This study explores the effects of telerehabilitation and a study medication on rehabilitation outcomes in patients with stroke resulting in arm weakness. Patients with arm weakness due to a stroke that happened in the past 30 days will be randomized into one of three groups: [1] TR and placebo (a sugar pill) on top of usual care; [2] TR and a medication (Sinemet 25/100) on top of usual care; [3] or usual care alone (no TR and no pill, but people in this 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Measured at baseline and 3 months later

Month 3
Change in Action Research Arm Test score from baseline to 3 months
Change in Arm Motor Fugl-Meyer Scale from baseline to 3 months

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Telerehabilitation + Sinemet
1 of 3
Usual care
1 of 3
Telerehabilitation + Placebo
1 of 3
Active Control
Non-Treatment Group

72 Total Participants · 3 Treatment Groups

Primary Treatment: Telerehabilitation + Sinemet · Has Placebo Group · Phase 1 & 2

Telerehabilitation + SinemetActiveComparator Group · 2 Interventions: Telerehabilitation, Sinemet Pill · Intervention Types: Device, Drug
Telerehabilitation + PlaceboPlaceboComparator Group · 2 Interventions: Telerehabilitation, Placebo · Intervention Types: Device, Drug
Usual careNoIntervention Group · 1 Intervention: Usual care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at baseline and 3 months later
Closest Location: California Rehabilitation Institute · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2020First Recorded Clinical Trial
3 TrialsResearching Stroke
2 CompletedClinical Trials

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,381 Previous Clinical Trials
6,521,075 Total Patients Enrolled
30 Trials studying Stroke
3,330 Patients Enrolled for Stroke
Steven CramerPrincipal InvestigatorUniversity of California, Los Angeles

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be between the ages of 18 and 65 years old.
You must be able to use at least 3 different input devices.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References