Error-enhanced Learning & Recovery in 2 & 3 Dimensions
Primary Purpose
Stroke, Cerebral Vascular Accident (CVA)/Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Error Fields
No Error Fields
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Upper Extremity, Rehabilitation, Arm, Robotics, Stroke
Eligibility Criteria
Inclusion Criteria:
- Chronic stroke (at least 8 months post stroke)
- Available medical records and radiographic information about lesion locations
- Hemiparesis
- Some degree of both shoulder and elbow movement
- A "moderate" impairment of arm function (Fugl-Meyer score between 15-50)
Exclusion Criteria:
- Bilateral paresis
- Severe tactile deficits using the Two-Point Discrimination Test
- Severe Spasticity preventing movement
- Aphasia, cognitive impairment, or affective dysfunction that would influence ability to perform the experiment
- Inability to provide informed consent
- Severe current medical problems
- Diffuse/multiple lesion sites or multiple stroke events
- Hemispatial neglect or visual field cut that would prevent subjects from seeing the targets
- Individuals under the age of 21 will no be included since this study is focused on motor behavior and learning of fully developed nervous system
- 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 study intervention protocol or a prescribed therapy
- Participation in previous, similar robotics intervention study
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
Sites / Locations
- Shirley Ryan AbilityLab (Healthy Participants)Recruiting
- Shirley Ryan AbilityLabRecruiting
- Shirley Ryan AbilityLabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
Perpendicular Error
Secondary Outcome Measures
Action Research Arm Test
Full Information
NCT ID
NCT05180786
First Posted
November 4, 2021
Last Updated
August 17, 2023
Sponsor
Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT05180786
Brief Title
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
Official Title
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Vascular Accident (CVA)/Stroke
Keywords
Upper Extremity, Rehabilitation, Arm, Robotics, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Title
Group 2
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Error Fields
Intervention Description
Participants will complete a reaching experiment using the robotic arm with error fields turned on.
Intervention Type
Other
Intervention Name(s)
No Error Fields
Intervention Description
Participants will complete a reaching experiment using the robotic arm with error fields turned off.
Primary Outcome Measure Information:
Title
Perpendicular Error
Time Frame
60-90 minutes
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Time Frame
5-20 minutes
Other Pre-specified Outcome Measures:
Title
Upper Extremity portion of the Fugl-Meyer
Time Frame
5-20 minutes
Title
Box and Blocks
Time Frame
5-20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Celian
Phone
3122381560
Email
ccelian@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Naveed Aghamohammadi
Phone
7654215544
Email
nagham2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Patton, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab (Healthy Participants)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveed Aghamohammadi
Phone
765-421-5544
Email
nagham2@uic.edu
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Celian, MSOT
Phone
312-238-1560
Email
ccelian@sralab.org
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Celian, MS
First Name & Middle Initial & Last Name & Degree
James Patton, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Error-enhanced Learning & Recovery in 2 & 3 Dimensions
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