Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

March 10, 2025 updated by: Steven C. Cramer, MD, FAAN, FAHA, University of California, Los Angeles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Participants with arm weakness due to a stroke in the past 30 days will be randomized into one of three groups: (1) TR + Sinemet on top of usual care, (2) TR + placebo (sugar pill) on top of usual care, or (3) usual care only (no TR, no pill). The hypothesis of this study is patients receiving TR will have significantly greater recovery of arm function compared to patients receiving usual care. In addition, Sinemet is hypothesized to significantly enhancing this improvement.

Study participation will last up to 3 months and includes 4 in-person visits. At these visits, patients will undergo a battery of assessments including arm function, a single MRI scan of the brain, and blood draw for genotyping. Patients undergoing TR will receive arm motor training, which consists of 36 sessions of of assigned exercises, games, and stroke education; these are 70 minutes in length and take 6 days a week over 6-8 weeks. Subjects receiving TR will take a pill (Sinemet or placebo) prior to the TR training for the first 18 TR sessions; TR subjects will also continue usual care. Patients in the usual care group will not engage in TR or take a study pill, but will instead continue all of the therapies recommended by their medical team. At the end of the study, participants in the usual care group will be offered TR.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90067
        • California Rehabilitation Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

  1. Age 18 years or older
  2. Stroke that has been radiologically verified and has time of onset 30 days or less from the time of randomization
  3. ARAT score of <32 (out of 57) at Visit 1

  4. At Visit 1, either

    1. BBT score with affected arm is at least 1 block in 60 seconds OR
    2. There is a visible flicker in each of the following movements with gravity eliminated: wrist extension and finger flexion

  5. At Visit 1, either

    1. The range of motion against gravity must be ≥45 degrees in both the paretic shoulder and elbow OR
    2. the patient must be able to use at least 3 different telerehab system input devices
  6. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)

EXCLUSION CRITERIA

  1. A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
  2. Major medical disorder that reduces subject's ability to comply with study procedures
  3. Severe depression, defined as CES-D score >24 at screening visit

  4. Significant cognitive impairment, defined as presence of either

    1. Montreal Cognitive Assessment (MoCA) score <22 OR
    2. Trail Making Test: Part A score ≤14
    3. Note that lower scores may be permitted if due to aphasia and if the patient is specifically allowed by Dr. Cramer
  5. Deficits in communication that interfere with reasonable study participation
  6. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
  7. Life expectancy <6 months
  8. Pregnant
  9. Botox to arms, legs or trunk in the preceding 4 months, or expectation that Botox will be administered to the arm, leg or trunk within 3 months of study enrollment
  10. Unable to successfully perform all 3 rehabilitation exercise test examples
  11. Unable or unwilling to perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
  12. Non-English or non-Spanish speaking, such that subject does not speak either language sufficiently to comply with study procedures
  13. Isolation due to active COVID-19

  14. Any contraindication to L-Dopa:

    1. Patient is currently taking a monoamine oxidase inhibitor; if the patient took such a drug in the past, it must be discontinued at least two weeks prior to study enrollment
    2. Known hypersensitivity to any component of Sinemet
    3. Narrow-angle glaucoma; if wide-angle glaucoma is present, the patient can only be enrolled with explicit written approval from their ophthalmologist
    4. History of melanoma or suspected melanoma
    5. Patient is currently taking phenytoin, papaverine, isoniazid, or a dopamine D2 receptor antagonist (such as a phenothiazine, butyrophenone, or risperidone)
    6. Currently taking a direct dopaminergic agonist
  15. Expectation that subject will not have single domicile address during 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for TR system, and is within 30 miles of Cal Rehab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Telerehabilitation + Sinemet
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Sinemet is taken one hour before starting TR, for the first 18 sessions.
Device: Telerehabilitation
The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
Drug: Sinemet Pill
Sinemet 25/100 will be taken 1 hour prior to TR, for the first 18 sessions.
Placebo Comparator: Telerehabilitation + Placebo
Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Placebo is taken one hour before starting TR, for the first 18 sessions.
Device: Telerehabilitation
The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.
Drug: Placebo
Placebo will be taken 1 hour prior to TR, for the first 18 sessions.
No Intervention: Usual care
Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Action Research Arm Test Score From Baseline to 3 Months
Time Frame: Measured at baseline and 3 months later
Measures arm function using a scale that runs from 0 to 57 points, with higher scores indicating greater arm function.
Measured at baseline and 3 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Arm Motor Fugl-Meyer Scale From Baseline to 3 Months
Time Frame: Measured at baseline and 3 months later
Measures arm motor impairment using a scale that runs from 0 to 66 points, with higher scores indicating greater arm motor function (less impairment)
Measured at baseline and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Steven Cramer, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

March 11, 2024

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-000104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified dataset will be shared with appropriate personnel after the main study manuscript is published

IPD Sharing Time Frame

likely starting 1-2 years after study completion, lasting for several years thereafter

IPD Sharing Access Criteria

Data will be shared using common data formats with appropriate personnel

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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