Clinical trial NCT03300258: Robotic Pedaling Therapy for Targeted Neural Plasticity
Official title: Robotic Pedaling Therapy for Targeted Neural Plasticity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-10-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Change in Six Minute Walk Test (6MWT) Distance
timeFrame: Baseline and at 5 weeks
Secondary outcomes:
measure: Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)
timeFrame: Baseline and at 5 weeks
measure: Change in Timed Up-and-Go Test (TUG)
timeFrame: Baseline and at 5 weeks
measure: Change in Self-Selected Walking Speed (SSWS)
timeFrame: Baseline and at 5 weeks
measure: Change in Fastest Comfortable Walking Speed (FCWS)
timeFrame: Baseline and at 5 weeks
measure: Change in Center of Pressure (COP) Characteristics
timeFrame: Baseline and at 5 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Peter G Adamczyk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: