The Intensive Stroke Cycling for Optimal Recovery and Economic Value Trial: Protocol for a Randomized Clinical Trial.
Courtney R Miller, Dawn Taylor, Francois Bethoux, Andrea Bischof-Bockbrader, Tara M DeSilva, Matthew C Streicher, Brittany Lapin, Belinda L Udeh, Tamanna Singh, Cynthia Clark, Lindsay Kwasny, Mary O'Neill, Donayja Harris, Susan M Linder
Abstract
Open AccessIMPORTANCE: Current rehabilitative approaches for the recovery of upper extremity (UE) and lower extremity (LE) function following stroke involve costly time- and personnel-intensive 1-on-1 motor learning-based training. Preliminary data in chronic stroke indicate facilitated aerobic exercise (FE), where volitional LE movements are mechanically supplemented, enhances UE motor recovery associated with task-based practice. OBJECTIVE: The goals of the Intensive Stroke Cycling for Optimal Recovery and Economic Value trial are to determine effects of FE in facilitating UE and LE motor recovery post-subacute stroke, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost-effectiveness of a FE-centered intervention. DESIGN: A prospective, single-center, parallel group, rater-blind, pragmatic randomized clinical trial will be conducted. SETTING: The setting will be a large academic medical institution. PARTICIPANTS: Individuals with hemiparesis due to subacute stroke (N = 66) will be enrolled. INTERVENTIONS: Participants will be randomized into FE followed by abbreviated sessions of physical and occupational therapy (FE + rehab) or usual care consisting of consecutive sessions of physical and occupational therapy (rehab). All participants will receive a comparable dose of contact time: 90 minutes, 2 times per week for 12 weeks. MAIN OUTCOMES: Motor outcomes will be collected at baseline, end of treatment (EOT) and EOT + 6 months. Electroencephalograms and blood biomarkers will be collected at baseline and EOT. Cost-effectiveness will be modeled over immediate and long-term horizons. RELEVANCE: 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. The mechanistic aim will explore the effects of each approach on substrates underlying neuroplasticity.