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MyoRegulator® Device for Post-Stroke Muscle Spasms (RECOVER Trial)
RECOVER Trial Summary
This trial will compare the effects of a new device called the MyoRegulator®, which uses electrical stimulation, to a sham device in stroke patients with upper-extremity spasticity. The study will last for 5 days, and safety and performance of the MyoRegulator® will be assessed.
RECOVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRECOVER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RECOVER Trial Design
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Who is running the clinical trial?
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- I haven't had phenol or alcohol injections in the limb for the study in the last 6 months.I agree not to undergo arm therapy while in the study.I have one brain lesion, confirmed by MRI or CT, diagnosed over 6 months ago.I have had surgery before to address muscle stiffness.I agree not to use certain muscle treatments or specific drugs during the study.I have not had botulinum toxin injections in the limb for the study in the last 12 weeks.I haven't changed my muscle spasm medication in the last 2 months.My arm stiffness has been stable for 6 weeks and is moderately severe.I am between 18 and 84 years old.I haven't used digitalis, morphine, or an intrathecal pump in the last week.Criterion: You have damaged skin or sensory issues at the stimulation sites, implants that can be affected by electricity, metal in the path of the current flow, a history of seizures or loss of consciousness, certain neurological conditions, other medical conditions that may interfere with the study, previous participation in a similar study, or are pregnant.I have had brain or spinal cord stimulation treatment before.I can understand and follow the study's instructions.I agree to keep taking my current spasticity and neurotransmitter medications during the study.My wrist affected by spasticity is severely stiff or has significant muscle loss.
- Group 1: Active Stimulation
- Group 2: Sham Stimulation
- 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
Are senior citizens above the age of 85 eligible for this experiment?
"The age range for this clinical trial spans from 18 to 85 years old."
What is the endgame of this medical experiment?
"The primary outcome of this clinical trial, monitored over a 2-6 week period after the treatment has been administered, is to observe any fluctuations in wrist flexor spasticity when compared to the baseline as evaluated by the Modified Ashworth Scale score. Secondary outcomes include changes in Upper-Extremity Fugl-Meyer motor domain scores from prior and post 5 treatments up to 3 months later; alterations in Modified Tardieu Scale total upper limb score following 5 days of treatment comparably with its pre-treatment state; and lastly shifts in Modified Ashworth Scale total upper limb score also following 5 days of therapy relative to its"
To whom is this clinical trial open for enrolment?
"This trial is recruiting 76 individuals aged 18-85 that have experienced a stroke. To qualify for the study, patients must satisfy several criteria such as having stable spasticity symptoms with a Modified Ashworth Scale score of 1+ to 3 (on the 0, 1, 1+, 2, 3, 4 scale), being willing to abstain from certain treatments and therapies during their participation in the study; demonstrating sufficient cognitive function; and presenting evidence of a single focal unilateral hemisphere lesion verified by brain imaging at least 6 months prior to enrollment."
Are there vacancies available in this clinical trial?
"According to the online resources of clinicaltrials.gov, this medical trial is currently seeking enrolment from volunteers. It was initially posted on March 4th 2022 and has been revised more recently on July 22nd 2022."
What is the current enrolment number for this clinical trial?
"Affirmative. Clinicaltrials.gov signifies that this research trial, which was originally published on March 4th 2022 is actively recruiting individuals to participate. Currently, 76 participants must be enlisted across two different medical centres."
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