Robotic Pedaling Therapy for Targeted Neural Plasticity

University of Wisconsin (UW)

Status

Terminated

Conditions

Stroke

Treatments

Device: Aerobic therapy

Device: Robotic therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03300258

ENGR\MECHANICAL ENGR (Other Identifier)

2016-1279

Protocol Version 1.8, 3/2017 (Other Identifier)

4UL1TR000427-10 (U.S. NIH Grant/Contract)

A196200 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patients:

Inclusion criteria:

Subjects will be stroke patients with persistent moderate unilateral lower extremity deficits, age 50-85 years at time of enrollment.
Time since stroke will be greater than 6 months ("chronic" stroke survivors).
Persistent moderate unilateral lower-limb impairment (defined as NIH Stroke Scale - Motor Leg section score of 1-2, to be discussed with the patient verbally during phone screening and assessed by the investigator during the initial enrollment visit).
Fluent in spoken and written English

Exclusion criteria:

Allergy to electrode gel, surgical tape and metals.
Subjects under treatment for infectious diseases will be excluded from the study.
Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
Contraindications for MRI
Age over 85 years at time of enrollment.

Healthy Controls:

Inclusion criteria:

Ages 18-85 years
Non-Stroke Group 1 ("Matched Controls"): 50-85 years old at time of enrollment, to match the population of stroke patients to be studied
Non-Stroke Group 2 ("Pilot Controls"): 18-50 years old at time of enrollment (Pilot subjects to be initially enrolled early in the design phase of the study, and with enrollment ongoing throughout the study to continue development.)
No known neurologic, psychiatric or developmental disability.
Fluent in spoken and written English

Exclusion criteria:

Allergy to electrode gel, surgical tape, and metals.
Subjects under treatment for infectious diseases will be excluded from the study.
Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
Contraindications for MRI
Age over 85 years at time of enrollment.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 4 patient groups

Non-Stroke Pilot Group

Other 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.

Treatment:

Device: Robotic therapy

Device: Aerobic therapy

Non-Stroke Comparison Group

Other 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.

Treatment:

Device: Robotic therapy

Robotic Training Group

Experimental group

Description:

Robotic therapy. Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.

Treatment:

Device: Robotic therapy

Aerobic Training Group

Active Comparator group

Description:

Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.