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

NCT06585943 | Recruiting DMC

• 1 other identifier: IRB 23-1262
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

aerobic exercise; physical therapy; occupational therapy

Outcome Measures

Primary Outcomes (9)

• Upper Extremity Fugl-Meyer Motor Assessment

  Impairment-based measure of the upper extremity post-stroke.

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

• Gait Velocity

  Gait velocity obtained using motion capture.

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

• Plasma IGF-1

  Blood biomarker for neuroplasticity

  Before and after first and 24th treatment session

• Serum BDNF

  Blood biomarker for neuroplasticity

  Before and after first and 24th treatment session

• electroencephalograms

  Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas during active/passive UE and LE movements

  Baseline and end of treatment at 12 weeks

• electroencephalograms

  Electroencephalograms will be obtained to determine the degree of active engagement of different cortical areas under each cycling condition

  Baseline and end of treatment at 12 weeks

• electroencephalograms

  Electroencephalograms will be obtained to quantify inter-area communication and direction of information flow.

  Baseline and end of treatment at 12 weeks

• Incremental cost-effectiveness ratio

  Incremental cost-effectiveness ratio (ICER) expressed as cost per quality of life years (QALY) will be computed using a healthcare perspective.

  baseline to end of treatment at 12 weeks and baseline to end of treatment + 6 months

• Stroke Impact Scale

  Self-reported quality of life measure, normalized to a score from 0-100 with higher scores indicative of better self-reported quality of life

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

Secondary Outcomes (19)

• Action Research Arm Test

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

• Biomechanical Dexterity Task

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

• Biomechanical measure of maximum grasp force

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

• Bimanual Dexterity Task

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

• Six minute walk test

  Baseline to end of treatment at 12 weeks and end of treatment + 6 months

Study Arms (2)

Forced Rate Exercise + Rehabilitation

ACTIVE COMPARATOR

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).

Behavioral: Forced Rate Exercise + Rehab

Rehabilitation

ACTIVE COMPARATOR

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).

Behavioral: Rehabilitation

Interventions

Forced Rate Exercise + Rehab BEHAVIORAL

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).

Forced Rate Exercise + Rehabilitation

Rehabilitation BEHAVIORAL

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).

Rehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify 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 interventional 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Susan Linder, PT, DPT, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Miller, PT, DPT

CONTACT

216 509-7012; millerc5@ccf.org

Donayja Harris, BS

CONTACT

216 445-2007; harrisD47@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective, single-center, parallel group, rater-blind, pragmatic randomized clinical trial

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)