Robotic Pedaling Therapy for Targeted Neural Plasticity

NCT ID: NCT03300258

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-06-29

Brief Summary

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

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Non-Stroke Pilot Group

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.

Group Type: OTHER

Robotic therapy

Intervention Type: DEVICE

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.

Aerobic therapy

Intervention Type: DEVICE

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.

Non-Stroke Comparison Group

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.

Group Type: OTHER

Robotic therapy

Intervention Type: DEVICE

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.

Robotic Training Group

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

Group Type: EXPERIMENTAL

Robotic therapy

Intervention Type: DEVICE

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.

Aerobic Training Group

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

Group Type: ACTIVE_COMPARATOR

Aerobic therapy

Intervention Type: DEVICE

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.

Interventions

Robotic therapy

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.

Intervention Type: DEVICE

Aerobic therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.

Healthy Controls:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter G Adamczyk, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin, Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A196200

Identifier Type: OTHER

Identifier Source: secondary_id

ENGR\MECHANICAL ENGR

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1.8, 3/2017

Identifier Type: OTHER

Identifier Source: secondary_id

4UL1TR000427-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-1279

Identifier Type: -

Identifier Source: org_study_id