Stroke study: Rehabilitation
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
- The study will find out whether forced aerobic exercise helps stroke survivors regain movement in their arms and legs, and whether it is cheaper than usual rehab. It will also look at how the exercise changes the brain and body.
- Who it's for
- Adults who have experienced a stroke and still have difficulty moving their arms or legs.
- What's involved
- Participants will do supervised, mechanically assisted cycling sessions at an outpatient rehab center, along with standard care, and will undergo motor function tests and other assessments.
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
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.