Stroke Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People whose affected arm scores between 22 and 50 (inclusive) on a standard arm movement assessment called the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE).
• People whose FMA-UE arm assessment score changes by no more than 3 points between the first screening appointment and the baseline appointment.
• People aged 18 to 80 years (inclusive).
• People who had a stroke caused by a blocked blood vessel or a bleed within the brain.
• People who are more than 6 months but no more than 5 years past their stroke.
• People whose affected arm can move at least 1 block in 60 seconds on a standard hand function test (Box & Block Test) at the baseline visit.
• People who are able to sit using the study device for 40 minutes in a row.
• People who can follow a 3-step spoken instruction (for example: "take the paper, fold it in half, and return it to me"), or an equivalent non-verbal instruction.
• People who are willing to take part in physical exercises during the study sessions.
• People who have a family member or other caregiver available to help during study treatment sessions and visits.
• Women who are not pregnant, not breastfeeding, and not planning to become pregnant during the study period.
• People who have signed a consent form agreeing to take part.

Who may not be able to join:

• People with severe inattention or neglect that would interfere with assessments or treatment.
• People with severe depression, defined as scoring more than 10 out of 15 on a standard depression scale (GDS).
• People who have implanted devices or retained metal objects that are not safe for MRI scanning, or who have a life-sustaining device such as a pacemaker or internal heart defibrillator (even if MRI-compatible).
• People with active epilepsy, currently taking medication to control seizures, or who have had any epileptic seizure in the last 5 years.
• People who have received botulinum toxin (such as Botox) injections in the affected arm within the past 3 months, or who are expected to receive such injections before the 6-month study visit.
• People with severe stiffness or tightness (spasticity) in the affected arm, specifically a score of 3 or higher on a standard spasticity scale in either the biceps or chest muscle, or a fixed tightening of the arm joints (contracture).
• People with a pre-existing neurological condition (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, brain injury, or spinal cord injury) or a physical limitation that would significantly interfere with participation or make it hard to evaluate results.
• People with significant vision problems — existing before or caused by the stroke — that cannot be corrected and would significantly interfere with participation or evaluation.
• People with a serious unstable health condition (such as active cancer, severe heart failure, or a major active psychiatric condition) or a life expectancy of less than 12 months.
• People with a history of alcohol or illicit drug misuse in the past 6 months that is likely to affect their ability to fully take part in the trial.
• People currently taking part in another interventional research trial that could conflict with this study.
• People who have taken part in a formal upper limb rehabilitation program run by a licensed provider in the 4 weeks before the screening visit, or who plan to do so at any point between the screening visit and the primary endpoint visit.
• Employees of the company sponsoring this trial.
• People who are currently imprisoned.

Important: Always verify eligibility with the trial site directly before applying.