Robotic Pedaling Therapy for Targeted Neural Plasticity

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • 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.

Outcomes

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

Sponsors