Recruiting

Intensive Stroke CyclingI-Score: Intensive Stroke Cycling for Optimal Recovery and Economic Value

Sponsor:

The Cleveland Clinic

Code:

NCT06585943

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Forced Rate Exercise + Rehab

Rehabilitation

Study Details

Brief summary:

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. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance.

Conditions

Stroke

Study ID

NCT06585943

Start date

Sep 18, 2024

Status verified date

Sep, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

1. 3-9 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging (ie: first-time stroke)
2. Fugl-Meyer motor score 19-55 in the involved UE
3. Fugl-Meyer score <34 in the involved LE demonstrating residual hemiparesis
4. Ambulatory ≥ 20 meters with no more than contact guard assistance
5. 18-85 years of age

Exclusion criteria include:

1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
2. cardiac arrhythmia
3. hypertrophic cardiomyopathy
4. history of multiple strokes
5. actively undergoing physical or occupational therapy or enrolled in another interventional study
6. severe aortic stenosis
7. untreated deep vein thrombosis or pulmonary embolus
8. unstable angina
9. uncontrolled hypertension
10. implanted pacemaker or defibrillator
11. dyspnea at rest
12. clinically significant neurologic condition/diagnosis other than stroke
13. recent history of elicit drug or alcohol misuse or significant mental health illness
14. significant contractures
15. anti-spasticity injection within 3 months of enrollment
16. skull hardware (e.g. screws/plates) or prior craniotomies that could shunt current flow altering EEG measures
17. other contraindication to exercise or EEGs

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Forced Rate Exercise + Rehabilitation

The forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to >75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).

active comparator: Rehabilitation

The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).

Interventions

Forced Rate Exercise + Rehab

The FE+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to >75 RPM. Target heart rate zone will be set to 60-80% of HR reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).

Rehabilitation

Primary outcome measure

Upper Extremity Fugl-Meyer Motor Assessment [ Time Frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months ]
Gait Velocity [ Time Frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months ]
Plasma IGF-1 [ Time Frame: Before and after first and 24th treatment session ]
Serum BDNF [ Time Frame: Before and after first and 24th treatment session ]
electroencephalograms [ Time Frame: Baseline and end of treatment at 12 weeks ]
electroencephalograms [ Time Frame: Baseline and end of treatment at 12 weeks ]
electroencephalograms [ Time Frame: Baseline and end of treatment at 12 weeks ]
Incremental cost-effectiveness ratio [ Time Frame: baseline to end of treatment at 12 weeks and baseline to end of treatment + 6 months ]
Stroke Impact Scale [ Time Frame: Baseline to end of treatment at 12 weeks and end of treatment + 6 months ]

Central Contacts and Locations

Central contacts

Courtney Miller, PT, DPT

216 509-7012 millerc5@ccf.org

Donayja Harris, BS

216 445-2007 harrisD47@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Courtney R Miller, DPT

216-509-7012 millerc5@ccf.org

Donayja Harris, BS

harrisd47@ccf.org

Principal Investigator:

Susan M Linder, DPT, PhD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

aerobic exercise
physical therapy
occupational therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.