The aim of this Pilot study is to determine whether robotically targeted lower-limb pedaling therapy can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Forty (40) adult stroke patients and 80 healthy controls will be enrolled in this study. Of the 40 patients, half will be randomly assigned to the robotically-targeted training ("robotic") group and will receive training on the targeted training task. The other half of the patients will perform a duration-matched aerobic pedaling exercise ("control" group). All stroke patients will be scanned before and after their training program while performing or imagining simple motor tasks. Behavioral assessments of motor and cognitive capacities will be collected at each timepoint. Healthy control subjects enrolled for device testing (20) will receive up to 5 training sessions in a modified robotic paradigm and 1 fMRI scan, in order to investigate motor learning and brain activity in a novel motor control task. Additional healthy pilot subjects (up to 60) will test training protocols and assessments during preparatory design phases of the project.
- Robotic therapy Device
Intervention Desc: The "Robotic" group will use a robotic training protocol to incentivize recovery of motor control by changing task demands throughout the training period. One or more target tasks will be chosen to mimic different sub-functions of gait, including some which are not normally excited in typical cycling behavior. Also, tasks may be designed to target non-gait motions such as hip ab/adduction. The required task may be changed periodically. This therapy protocol will occupy 30 minutes of each training session. Prior to testing, EMG electrodes will be placed on the major muscles of both legs, a procedure that takes roughly 15 minutes. Another 15 minutes is for changing clothes, briefing the subject, and other ancillary study activities. The total time per training session is 1 hour. ARM 1: Kind: Experimental Label: Non-Stroke Pilot Group Description: Robotic therapy. Aerobic therapy. Subjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined. ARM 2: Kind: Experimental Label: Non-Stroke Comparison Group Description: Robotic therapy. Healthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke. ARM 3: Kind: Experimental Label: Robotic Training Group Description: Robotic therapy. Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.
- Aerobic therapy Device
Intervention Desc: The Control group protocol is identical to that of the Robotic group, except the robotically-incentivized exercise is replaced with an aerobic exercise. This intervention emulates a commercial motorized exercise bike to improve cardiovascular unfitness contributions to gait impairment. This therapy implements assist-as-needed and constant-velocity control. The patient's target pedaling speed (e.g. 20 rev/min (to be finalized through pilot tests) and power level (set by heart rate to require approximately 50-70% of maximal oxygen uptake) are set at the beginning of each session and a motor provides assistance or resistance to compensate for the performance of the patient. The exercise will be performed in this mode for 30 minutes per training session. ARM 1: Kind: Experimental Label: Non-Stroke Pilot Group Description: Robotic therapy. Aerobic therapy. Subjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined. ARM 2: Kind: Experimental Label: Aerobic Training Group Description: Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change in Six Minute Walk Test (6MWT) Distance||Baseline and at 5 weeks|
|Secondary||Change in Brain Activity in and near Affected Areas, through Functional MRI||Baseline and at 5 weeks|
|Secondary||Change in Timed Up-and-Go Test (TUG)||Baseline and at 5 weeks|
|Secondary||Change in Self-Selected Walking Speed (SSWS)||Baseline and at 5 weeks|
|Secondary||Change in Fastest Comfortable Walking Speed (FCWS)||Baseline and at 5 weeks|
|Secondary||Change in Center of Pressure (COP) Characteristics||Baseline and at 5 weeks|