StrokeNCT03300258
Robotic Pedaling Therapy for Targeted Neural Plasticity
A study testing Robotic therapy and Aerobic therapy in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic therapy and Aerobic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 29 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53706
About this study
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
- Being tested
- Robotic therapy, Aerobic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic therapyDevice
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Robotic therapy |
| Aerobic Training Group | Active comparator | Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group. Receives: Device: Aerobic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six Minute Walk Test (6MWT) Distance
A simple series of laps along a 30 m straight path in a level hallway.
Measured: Baseline and at 5 weeks
Secondary outcomes (5)
Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)
fMRI scans will be used to measure task-specific cortical activity in sensorimotor areas during physical stepping with an MRI-compatible stepping machine, or imagined/visualized cycling.
Measured: Baseline and at 5 weeks
Change in Timed Up-and-Go Test (TUG)
A simple timed test of how long it takes to stand up, walk 10 feet, turn around, return to the starting point, and sit down.
Measured: Baseline and at 5 weeks
Change in Self-Selected Walking Speed (SSWS)
A simple test of the speed a person chooses to walk over a 5-meter distance
Measured: Baseline and at 5 weeks
Change in Fastest Comfortable Walking Speed (FCWS)
A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance
Measured: Baseline and at 5 weeks
Change in Center of Pressure (COP) Characteristics
Movement of the Center of Pressure during standing, with eyes open and eyes closed. With eyes open, subjects focus their eyes on a spot on the wall in front of them. Metrics of COP control include excursion, average velocity, standard deviation, and an estimate of center of mass location.
Measured: Baseline and at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Jun 2019
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Why it stopped: Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Peter G Adamczyk, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300258
- Sponsor's protocol ID
- 2016-1279
- Other IDs
- A196200, ENGR\MECHANICAL ENGR, Protocol Version 1.8, 3/2017, 4UL1TR000427-10
- Status last verified
- Oct 2023
- First submitted
- 12 Jun 2017
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Pedaling Therapy for Targeted Neural Plasticity
- ClinicalTrials.gov ID
- NCT03300258
- Acronym / sponsor ID
- 2016-1279
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Stroke Pilot Group | Other | Device: Robotic therapy, Device: Aerobic therapyRobotic 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. |
| Non-Stroke Comparison Group | Other | Device: Robotic therapyRobotic therapy. Healthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke. |
| Robotic Training Group | Experimental | Device: Robotic therapyRobotic therapy. Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle. |
| Aerobic Training Group | Active comparator | Device: Aerobic therapyAerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic therapyThe "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. | Device | Non-Stroke Comparison Group, Non-Stroke Pilot Group, Robotic Training Group |
| Aerobic therapyThe 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. | Device | Aerobic Training Group, Non-Stroke Pilot Group |
Primary outcome
Change in Six Minute Walk Test (6MWT) Distance
Time frame: Baseline and at 5 weeks
A simple series of laps along a 30 m straight path in a level hallway.
5 secondary outcomes
Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)
Time frame: Baseline and at 5 weeks
Change in Timed Up-and-Go Test (TUG)
Time frame: Baseline and at 5 weeks
Change in Self-Selected Walking Speed (SSWS)
Time frame: Baseline and at 5 weeks
Change in Fastest Comfortable Walking Speed (FCWS)
Time frame: Baseline and at 5 weeks
Change in Center of Pressure (COP) Characteristics
Time frame: Baseline and at 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G Adamczyk, Ph.D. principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic therapy and Aerobic therapy in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Six Minute Walk Test (6MWT) Distance (time frame: Baseline and at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.