- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02570256
Deficit Fields for Stroke Recovery
June 8, 2021 updated by: James Patton, Shirley Ryan AbilityLab
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
This study investigates the potential of customized robotic and visual feedback interaction to improve recovery of movements in stroke survivors.
While therapists widely recognize that customization is critical to recovery, little is understood about how take advantage of statistical analysis tools to aid in the process of designing individualized training.
Our approach first creates a model of a person's own unique movement deficits, and then creates a practice environment to correct these problems.
Experiments will determine how the deficit-field approach can improve (1) reaching accuracy, (2) range of motion, and (3) activities of daily living.
The findings will not only shed light on how to improve therapy for stroke survivors, it will test hypotheses about fundamental processes of practice and learning.
This study will help us move closer to our long-term goal of clinically effective treatments using interactive devices.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Rehabilitation Institute of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
STROKE SURVIVORS:
- adult (age >18)
- Chronic stage stroke recovery (8+ months post)
- available medical records and radiographic information about lesion locations
- strokes caused by an ischemic infarct in the middle cerebral artery
- primary motor cortex involvement
- a Fugl-Meyer score (between 15-50) to evaluate arm motor impairment level
HEALTHY CONTROL PARTICIPANTS:
- adult (age >18)
- healthy individuals with no history of stroke or neural injury
Exclusion Criteria:
- bilateral paresis;
- severe sensory deficits in the limb
- severe spasticity (Modified Ashworth of 4) preventing movement
- aphasia, cognitive impairment or affective dysfunction that would influence the ability to perform the experiment
- inability to provide an 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deficit-fields to reduce error
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed.
We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
|
Stroke survivors exhibit error in both reaching extent and abnormal curvatures of motion.
Prior error augmentation techniques multiply error by a constant at each instant during movement.
However, magnification of spurious errors may provoke over-compensation.
We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed.
We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
|
Experimental: Deficit-fields to expand range of motion
Amplifying augmentation can expand motor exploration and improve skill retention in patients.
Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace.
We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1).
We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
|
Motor deficits manifest in the workspace limitations of joints, i.e. reduced range of motion, uneven extension-flexion, inter-joint coupling, and unwanted synergies.
Our work builds upon these ideas by augmenting self-directed movement for training coordination.
We found that amplifying augmentation can expand motor exploration and improve skill retention in patients.
Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace.
We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1).
We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
|
Experimental: Deficit-fields to improve function
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation.
We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
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Clinicians have recognized the benefits of training on everyday tasks (Hubbard, Parsons et al. 2009), as well as practice with whole-body actions (Boehme 1988; Bohannon 1995).
However, typical robotic systems have only a single contact point and cannot drive the multiple joints involved in functional tasks.
Visual distortions (e.g. a shift, rotation or stretch) can promote adaptation even without forces.
Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation.
We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arm motor recovery scores on the Fugl-Meyer
Time Frame: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in arm motor recovery as measured by Fugl-Meyer
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of blocks transferred in Box and Blocks Test
Time Frame: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in number of blocks transferred during Box and Blocks Test
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Modified Ashworth Scale (MAS)
Time Frame: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline in amount of spasticity in elbow flexors and extensors
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Elbow active range of motion (ROM)
Time Frame: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change from baseline measured in degrees for elbow flexion and extension
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Chedoke McMaster Stroke Assessment for Hand
Time Frame: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change in baseline in amount of hand motor recovery as measured by Chedoke scale
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Time and completion score for Action Research Arm Test (ARAT)
Time Frame: Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Change in baseline score and time for completion of functional measures as part of ARAT
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Baseline at beginning of week 1 and 3 prior to intervention; post-evaluation at end of week 4; follow-up evaluation at end of week 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James L Patton, PhD, Shirley Ryan AbilityLab
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2013
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
October 1, 2015
First Submitted That Met QC Criteria
October 6, 2015
First Posted (Estimate)
October 7, 2015
Study Record Updates
Last Update Posted (Actual)
June 10, 2021
Last Update Submitted That Met QC Criteria
June 8, 2021
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RehabilitationIC
- 2R01NS053606-05A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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