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New treatment option for Stroke
Official title I-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value
ClinicalTrials.gov ID: NCT06585943
What this study is testing
- What it's testing
- Traditional rehabilitation approaches are time and personnel intensive and costly, and leave \~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Sixty-six individuals with chronic stroke able to provide informed consent who meet the following criteria for inclusion will be recruited from the...
- 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
- Fugl-Meyer motor score 19-55 in the involved UE
- Fugl-Meyer score \<34 in the involved LE demonstrating residual hemiparesis
- Ambulatory ≥ 20 meters with no more than contact guard assistance
You likely can't join if
- include:
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
- cardiac arrhythmia
- hypertrophic cardiomyopathy
- history of multiple strokes
- actively undergoing physical or occupational therapy or enrolled in another treatment study
See the full eligibility criteria
- Sixty-six individuals with chronic stroke able to provide informed consent who meet the following criteria for inclusion will be recruited from the Cleveland Clinic:
- 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
- Fugl-Meyer motor score 19-55 in the involved UE
- Fugl-Meyer score \<34 in the involved LE demonstrating residual hemiparesis
- Ambulatory ≥ 20 meters with no more than contact guard assistance
- 18-85 years of age
- include:
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
- cardiac arrhythmia
- hypertrophic cardiomyopathy
- history of multiple strokes
- actively undergoing physical or occupational therapy or enrolled in another treatment study
- severe aortic stenosis
- untreated deep vein thrombosis or pulmonary embolus
- unstable angina
- uncontrolled hypertension
- implanted pacemaker or defibrillator
- dyspnea at rest
- clinically significant neurologic condition/diagnosis other than stroke
- recent history of elicit drug or alcohol misuse or significant mental health illness
- significant contractures
- anti-spasticity injection within 3 months of enrollment
- skull hardware (e.g. screws/plates) or prior craniotomies that could shunt current flow altering EEG measures
- other contraindication to exercise or EEGs
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.