Robotic Pedaling Therapy for Targeted Neural Plasticity

NCT03300258 | Terminated Results

• 5 other identifiers: 2016-1279A196200ENGR\MECHANICAL ENGRProtocol Version 1.8, 3/20174UL1TR000427-10
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Six Minute Walk Test (6MWT) Distance

  A simple series of laps along a 30 m straight path in a level hallway.

  Baseline and at 5 weeks

Secondary Outcomes (5)

• Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)

  Baseline and at 5 weeks

• Change in Timed Up-and-Go Test (TUG)

  Baseline and at 5 weeks

• Change in Self-Selected Walking Speed (SSWS)

  Baseline and at 5 weeks

• Change in Fastest Comfortable Walking Speed (FCWS)

  Baseline and at 5 weeks

• Change in Center of Pressure (COP) Characteristics

  Baseline and at 5 weeks

Study Arms (4)

Non-Stroke Pilot Group

OTHER

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.

Device: Robotic therapy; Device: Aerobic therapy

Non-Stroke Comparison Group

OTHER

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.

Device: Robotic therapy

Robotic Training Group

EXPERIMENTAL

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

Device: Robotic therapy

Aerobic Training Group

ACTIVE COMPARATOR

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

Device: Aerobic therapy

Interventions

Robotic therapy 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.

Non-Stroke Comparison Group; Non-Stroke Pilot Group; Robotic Training Group

Aerobic therapy 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.

Aerobic Training Group; Non-Stroke Pilot Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population.

Results Point of Contact

• Title: Peter Adamczyk
• Organization: University of Wisconsin, Madison

peter.adamczyk@wisc.edu

(608) 263-3231

Study Officials

• Peter G Adamczyk, Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: October 3, 2017
• Study Start: June 1, 2019
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)