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Dopaminergic Agent
Dopaminergic Therapy + Telerehabilitation for Stroke
Phase 1 & 2
Waitlist Available
Led By Steven Cramer
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At Visit 1, either BBT score with affected arm is at least 1 block in 60 seconds OR there is a visible flicker in each of the following movements with gravity eliminated: wrist extension and finger flexion
At Visit 1, either the range of motion against gravity must be ≥45 degrees in both the paretic shoulder and elbow OR the patient must be able to use at least 3 different telerehab system input devices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and 3 months later
Awards & highlights
Study Summary
This trial will test whether adding telerehabilitation and/or a medication to usual care can help improve arm function in patients with recent stroke.
Who is the study for?
This trial is for adults who've had a stroke within the last 30 days, resulting in arm weakness. They must be able to perform certain movements or use telerehab system devices, and not have any major medical issues that would prevent participation. Pregnant individuals, those with severe communication deficits, or anyone on specific medications like monoamine oxidase inhibitors are excluded.Check my eligibility
What is being tested?
The study tests if telerehabilitation (TR) and Sinemet (a medication) improve arm function after a stroke compared to usual care alone. Participants will either do TR exercises with a placebo pill, TR with Sinemet, or just receive their regular care without TR or pills.See study design
What are the potential side effects?
Sinemet may cause side effects such as nausea, dizziness upon standing up quickly due to low blood pressure (orthostatic hypotension), involuntary movements (dyskinesia), dry mouth, and trouble sleeping.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can move a block with my affected arm or slightly move my wrist and fingers without gravity.
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I can move my shoulder and elbow against gravity or use 3 different devices for remote rehab.
Select...
I had a stroke confirmed by imaging within the last 30 days.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline and 3 months later
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and 3 months later
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Action Research Arm Test score from baseline to 3 months
Secondary outcome measures
Change in Arm Motor Fugl-Meyer Scale from baseline to 3 months
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Telerehabilitation + SinemetActive Control2 Interventions
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.
Group II: Usual careActive Control1 Intervention
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.
Group III: Telerehabilitation + PlaceboPlacebo Group2 Interventions
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.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,537 Previous Clinical Trials
10,266,941 Total Patients Enrolled
35 Trials studying Stroke
8,340 Patients Enrolled for Stroke
Steven CramerPrincipal InvestigatorUniversity of California, Los Angeles
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or might have had melanoma in the past.I can move a block with my affected arm or slightly move my wrist and fingers without gravity.You are currently isolated because of having active COVID-19.You scored less than 32 out of 57 on a test at your first visit.You have trouble communicating in a way that would make it hard for you to take part in the study.You are not expected to live for more than 6 months.I have not had Botox in my arms, legs, or trunk in the last 4 months and do not plan to within the next 3 months.My best eye sees worse than 20/50, even with glasses or contacts.I cannot speak English or Spanish well enough for medical procedures.You cannot complete all three rehabilitation exercise tests.I am currently taking medications like phenytoin or risperidone.I can move my shoulder and elbow against gravity or use 3 different devices for remote rehab.I had a stroke confirmed by imaging within the last 30 days.You have trouble remembering things or following instructions, as shown by specific tests.You have narrow-angle glaucoma, unless your eye doctor gives written permission for you to participate.I will live within 30 miles of Cal Rehab and have a stable home with Verizon or WiFi for 6 weeks.I am willing and able to follow the study's procedures and attend all visits.I am 18 years old or older.I am currently on medication that directly stimulates dopamine receptors.I am not currently on any monoamine oxidase inhibitors, or I stopped them at least two weeks ago.You have a significant ongoing neurological or mental health condition, like alcoholism or dementia.You are allergic to any part of Sinemet.I have severe depression based on my CES-D score.
Research Study Groups:
This trial has the following groups:- Group 1: Telerehabilitation + Sinemet
- Group 2: Telerehabilitation + Placebo
- Group 3: Usual care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this medical trial?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which originated on August 1st 2022, is actively enrolling participants at present. The study requires 72 patients from a single medical centre to join it."
Answered by AI
What is the cap for participants involved in this experiment?
"Affirmative, the listing on clinicaltrials.gov reveals that this medical experiment is currently in search of participants. It was initially posted on August 1st 2022 and has seen its last update occur on September 14th 2022. In total, 72 individuals need to be enrolled from a single research site."
Answered by AI
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