StrokeNCT05180786
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
A study testing Error Fields and No Error Fields in people with Stroke and Cerebral Vascular Accident (CVA)/Stroke, run by Shirley Ryan AbilityLab at 3 sites in United States.
Trial summary
This study is being done to see how errors lead to improvement. Specifically, we are evaluating the errors stroke participants make during an upper extremity exercise program when reaching for a target using their affected arm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebral Vascular Accident (CVA)/Stroke
- What is being tested?
- Error Fields and No Error Fields
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Chronic stroke (8+ months post stroke event) with primary motor cortex involvement
- Hemiparesis
- Some degree of both shoulder and elbow movement capability
Who cannot join
- Bilateral paresis
- Severe tactile deficits using the Two-Point Discrimination Test (participant must detect<11mm)
- Severe proprioceptive deficits
- Severe spasticity (Modified Ashworth >3) preventing movement
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
- Visual deficits, and hemispatial neglect that would prevent the subjects from seeing the targets.
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- Inability to provide an informed consent
- severe current medical problems
- diffuse/multiple lesion sites or multiple stroke events
- Inability to attain and maintain testing positions
- Botox injection to the affected upper extremity within the previous 4 months
- Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
- Participation in previous, similar robotics intervention study
- Other neurological issues
- None of the following special populations will be included in this research study:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Vulnerable Populations
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Shirley Ryan AbilityLab (Healthy Participants)
Chicago, Illinois, 60611
Naveed Aghamohammadi, 765-421-5544, nagham2@uic.edu
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Courtney Celian, MSOT, 312-238-1560, ccelian@sralab.org
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Courtney Celian, MS
James Patton, PhD
About this study
This study is being done to see how errors lead to improvement. Specifically, we are evaluating the errors stroke participants make during an upper extremity exercise program when reaching for a target using their affected arm. Once we understand the participant's reaching errors, we plan to create a customized reaching exercise according to the individual's specific error tendencies which will lead to better performance on movement ability after training.
Read the detailed description
The neuroplasticity of motor re-learning is a key pathway for recovery in neurorehabilitation. One critical challenge to devising treatment plans for motor recovery is the wide variation that exists between individuals, across movement repetitions, and even within movements. Development of a learning model that looks at these factors would better relate diagnoses to treatments, providing personalization and efficiency to therapy. This proposal aims to advance rehabilitation by building a modeling framework that explores the trends and exploits a fundamental learning process - error. Our goal is to preliminarily test the direct effect of this new treatment in preparation for the randomized controlled study to come. Understanding how error leads to better performance will help us program future devices for therapy for optimal outcomes.
We are using research lab equipment at the Shirley Ryan AbilityLab (SRALab) Hospital's Robotics group. The equipment will be used to implement the reaching exercises and measure participant movement. The equipment includes:
- Barret b.u.r.t. arm robot with Teneo forearm attachment
- LookingGlass virtual reality display system
- Garmin Venu Sq fitness tracking wristwatch
Study Outline:
Week 1, Visit 1: Consent, In-Person Screening, and Baseline Evaluations Participants will sign a consent form. Then, they will undergo a screening process to check if they meet all the eligibility requirements. Participants that pass the in-person screening and agree to continue with the study will complete baseline evaluations which will consistent of upper extremity outcome measures, and a preliminary reaching experiment on the b.u.r.t. robotic arm.
Weeks 2-3, Visits 2-7: Treatment Visits In the following two weeks, participants will come to the lab three times a week. They will use the robotic arm, and complete several rounds of reaching exercises while looking in the virtual reality display system. Depending on the treatment visit, participants will either take home a fitness tracker, or be asked to return it.
Week 4, Visit 8: Post-Evaluations About a week after the treatment sessions, participants will return to the lab and complete the same evaluations they completed during visit 1 to see if there is any change.
Weeks 5-8: There will be no lab visits during this time.
Week 9, Visit 9: About 5-6 weeks after the treatment visits, participants will come back for follow-up evaluations. These will be the same outcome measures completed during the baseline and post-evaluation sessions.
- Conditions
- Stroke, Cerebral Vascular Accident (CVA)/Stroke
- Being tested
- Error Fields, No Error Fields
- Keywords
- Upper Extremity, Rehabilitation, Arm, Robotics, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error FieldsOther
Participants will complete a reaching experiment using the robotic arm with error fields turned on.
No Error FieldsOther
Participants will complete a reaching experiment using the robotic arm with error fields turned off.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Not described Receives: Other: Error Fields; Other: No Error Fields |
| Group 2 | Other | Not described Receives: Other: Error Fields; Other: No Error Fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perpendicular Error
Measured: 60-90 minutes
Secondary outcomes (1)
Action Research Arm Test
Measured: 5-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Mar 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Lanphier Patton, Shirley Ryan AbilityLab
- Investigators
- James Patton, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180786
- Sponsor's protocol ID
- STU00215000
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Error-enhanced Learning & Recovery in 2 & 3 Dimensions
- ClinicalTrials.gov ID
- NCT05180786
- Acronym / sponsor ID
- STU00215000
- Conditions
- Stroke, Cerebral Vascular Accident (CVA)/Stroke
- Keywords
- Upper Extremity, Rehabilitation, Arm, Robotics, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see how errors lead to improvement. Specifically, we are evaluating the errors stroke participants make during an upper extremity exercise program when reaching for a target using their affected arm. Once we understand the participant's reaching errors, we plan to create a customized reaching exercise according to the individual's specific error tendencies which will lead to better performance on movement ability after training.
Detailed description
The neuroplasticity of motor re-learning is a key pathway for recovery in neurorehabilitation. One critical challenge to devising treatment plans for motor recovery is the wide variation that exists between individuals, across movement repetitions, and even within movements. Development of a learning model that looks at these factors would better relate diagnoses to treatments, providing personalization and efficiency to therapy. This proposal aims to advance rehabilitation by building a modeling framework that explores the trends and exploits a fundamental learning process - error. Our goal is to preliminarily test the direct effect of this new treatment in preparation for the randomized controlled study to come. Understanding how error leads to better performance will help us program future devices for therapy for optimal outcomes.
We are using research lab equipment at the Shirley Ryan AbilityLab (SRALab) Hospital's Robotics group. The equipment will be used to implement the reaching exercises and measure participant movement. The equipment includes:
- Barret b.u.r.t. arm robot with Teneo forearm attachment
- LookingGlass virtual reality display system
- Garmin Venu Sq fitness tracking wristwatch
Study Outline:
Week 1, Visit 1: Consent, In-Person Screening, and Baseline Evaluations Participants will sign a consent form. Then, they will undergo a screening process to check if they meet all the eligibility requirements. Participants that pass the in-person screening and agree to continue with the study will complete baseline evaluations which will consistent of upper extremity outcome measures, and a preliminary reaching experiment on the b.u.r.t. robotic arm.
Weeks 2-3, Visits 2-7: Treatment Visits In the following two weeks, participants will come to the lab three times a week. They will use the robotic arm, and complete several rounds of reaching exercises while looking in the virtual reality display system. Depending on the treatment visit, participants will either take home a fitness tracker, or be asked to return it.
Week 4, Visit 8: Post-Evaluations About a week after the treatment sessions, participants will return to the lab and complete the same evaluations they completed during visit 1 to see if there is any change.
Weeks 5-8: There will be no lab visits during this time.
Week 9, Visit 9: About 5-6 weeks after the treatment visits, participants will come back for follow-up evaluations. These will be the same outcome measures completed during the baseline and post-evaluation sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Error Fields, Other: No Error Fields |
| Group 2 | Other | Other: Error Fields, Other: No Error Fields |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Chronic stroke (8+ months post stroke event) with primary motor cortex involvement
- Hemiparesis
- Some degree of both shoulder and elbow movement capability
Key exclusion criteria (20 listed)
- Bilateral paresis
- Severe tactile deficits using the Two-Point Discrimination Test (participant must detect<11mm)
- Severe proprioceptive deficits
- Severe spasticity (Modified Ashworth >3) preventing movement
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
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 |
|---|---|---|
| Error FieldsParticipants will complete a reaching experiment using the robotic arm with error fields turned on. | Other | Group 1, Group 2 |
| No Error FieldsParticipants will complete a reaching experiment using the robotic arm with error fields turned off. | Other | Group 1, Group 2 |
Primary outcome
Perpendicular Error
Time frame: 60-90 minutes
1 secondary outcome
Action Research Arm Test
Time frame: 5-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
James Patton, PhD principal investigator
Shirley Ryan AbilityLab
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error Fields and No Error Fields in people with Stroke and Cerebral Vascular Accident (CVA)/Stroke, run by Shirley Ryan AbilityLab at 3 sites 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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Courtney Celian (3122381560, ccelian@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perpendicular Error (time frame: 60-90 minutes). 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 24 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.