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Device-Assisted ADL Practice for Stroke Recovery
Study Summary
This trial looks at the effects of using a device to help practice activities of daily living for people with moderate to severe stroke. The goal is to improve UE motor recovery by measuring changes in clinical outcomes, UE kinematics, and functional and morphologic neuroplasticity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a tumor in my brainstem or cerebellum.I experience significant pain in my arms or back, rating it 5 or more out of 10.I have severe stiffness in my elbow, wrist, and fingers.I cannot lift my arm sideways or upwards to a right angle.I can attend sessions 3 times a week for 8 weeks and all evaluations.I have a history of a neurological disorder, but not stroke.My skin is healthy on the arm affected by my stroke.I have completed all my physical rehabilitation.You are currently using oxygen.You are able to have an MRI scan without any problems.I had arm or hand movement problems before my stroke.I have weakness or numbness in the limb not affected by my condition.I can open my hand at least 4 cm wide with help from a device and therapist.I understand and can agree to the study's procedures and risks.I have weakness on one side of my body, affecting my arm but can still move it a little.You have very serious loss of feeling in your hands, as shown by specific tests.I haven't had specific muscle-relaxing injections in my affected arm in the past 6-12 months.You have a cardiac pacemaker, implanted cardioverter defibrillator, or a neurostimulation device in your brain or spinal cord.My cognitive function score is 23 or higher.I do not have severe health issues like heart problems or uncontrolled high blood pressure.I have had an amputation above the wrist.I am between 21 and 80 years old.I have had a seizure in the past 6 months.I can lift my arm and straighten my elbow somewhat against gravity.I can sit for at least 1 hour without discomfort.
- Group 1: ReIn-Hand
- Group 2: ReIn-hand and robot
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What progressions or results do researchers anticipate from this clinical trial?
"This trial will assess the efficacy of a given intervention by gauging changes in Box and Blocks Test (BBT) scores from baseline to post-intervention. Secondary outcomes include alterations in Cortical Activity Ratio (CAR), Motor Activity Log, and Stroke Impact Scale (SIS). Data collection is set to occur twice prior to treatment, once per week during treatment, one more time after conclusion of said treatment, as well as at 3 months follow up."
Is this research initiative inviting individuals aged 50 and above to participate?
"This trial is seeking participants aged 21 up to 80 years. For individuals that fall outside this age range, there are 38 trials for those under 18 and 1006 studies available for seniors over 65."
Who is able to register for participation in this trial?
"This medical trial is enrolling 60 individuals aged 21-80 who are currently living with stroke. To be eligible, they must possess the ability to elevate their limb against gravity up to 75 degrees of shoulder flexion and generate active elbow extension; open hand with a thumb-to-index finger distance ≥4 cm when supported by the ReIn-Hand device; exercise sufficient motor control as indicated on UE FMA (10-40/66) and CMSA_H stage of the hand section ≤ 4 scales; have no need for physical rehabilitation or therapy post discharge; display intact skin on affected arm area; tolerate sitting for 1 hour minimum"
What is the limit of participants currently authorized for this research?
"Affirmative. Clinicaltrials.gov reveals that recruitment for this trial commenced on September 23rd 2019 and was last updated April 12th 2022, with 60 individuals required to participate across 2 sites."
Could potential participants still join this experiment?
"This clinical trial is presently welcoming enrollees, with the initial posting having been made on September 23rd 2019 and the most recent revision taking place on April 12th 2022 (as indicated by information provided at clinicaltrials.gov)."
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