StrokeNCT02570256
Deficit Fields for Stroke Recovery
A study testing Deficit-fields to reduce error, Deficit-fields to expand range of motion and Deficit-fields to improve function in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Deficit-fields to reduce error, Deficit-fields to expand range of motion and Deficit-fields to improve function
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2013to 30 Jun 2019
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Deficit-fields to reduce error, Deficit-fields to expand range of motion, Deficit-fields to improve function
- Keywords
- stroke, upper extremity, motor exploration, error augmentation, robotic rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deficit-fields to reduce errorBehavioural
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.
Deficit-fields to expand range of motionBehavioural
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).
Deficit-fields to improve functionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Deficit-fields to reduce error | Experimental | 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. Receives: Behavioral: Deficit-fields to reduce error |
| Deficit-fields to expand range of motion | Experimental | 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). Receives: Behavioral: Deficit-fields to expand range of motion |
| Deficit-fields to improve function | Experimental | 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. Receives: Behavioral: Deficit-fields to improve function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm motor recovery scores on the Fugl-Meyer
Change from baseline in arm motor recovery as measured by Fugl-Meyer
Measured: 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
Secondary outcomes (5)
Number of blocks transferred in Box and Blocks Test
Change from baseline in number of blocks transferred during Box and Blocks Test
Measured: 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
Modified Ashworth Scale (MAS)
Change from baseline in amount of spasticity in elbow flexors and extensors
Measured: 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
Elbow active range of motion (ROM)
Change from baseline measured in degrees for elbow flexion and extension
Measured: 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
Chedoke McMaster Stroke Assessment for Hand
Change in baseline in amount of hand motor recovery as measured by Chedoke scale
Measured: 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
Time and completion score for Action Research Arm Test (ARAT)
Change in baseline score and time for completion of functional measures as part of ARAT
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start1 May 2013
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, James Patton, Shirley Ryan AbilityLab
- Investigators
- James L Patton, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570256
- Sponsor's protocol ID
- RehabilitationIC
- Other IDs
- 2R01NS053606-05A1
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2015
- Last updated
- 10 Jun 2021
- Results posted
- No
Publications
Wright ZA, Majeed YA, Patton JL, Huang FC. Key components of mechanical work predict outcomes in robotic stroke therapy. J Neuroeng Rehabil. 2020 Apr 21;17(1):53. doi: 10.1186/s12984-020-00672-8.
PubMed 32316977
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. 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
- NCT02570256
- Acronym / sponsor ID
- RehabilitationIC
- Conditions
- Stroke
- Keywords
- stroke, upper extremity, motor exploration, error augmentation, robotic rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Oct 2015 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deficit-fields to reduce error | Experimental | Behavioral: Deficit-fields to reduce errorWe 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. |
| Deficit-fields to expand range of motion | Experimental | Behavioral: Deficit-fields to expand range of motionAmplifying 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). |
| Deficit-fields to improve function | Experimental | Behavioral: Deficit-fields to improve functionHere 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Deficit-fields to reduce errorStroke 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. | Behavioural | Deficit-fields to reduce error |
| Deficit-fields to expand range of motionMotor 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). | Behavioural | Deficit-fields to expand range of motion |
| Deficit-fields to improve functionClinicians 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. | Behavioural | Deficit-fields to improve function |
Primary outcome
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
Change from baseline in arm motor recovery as measured by Fugl-Meyer
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Derived from this study: PubMed 32316977Wright ZA, Majeed YA, Patton JL, Huang FC. Key components of mechanical work predict outcomes in robotic stroke therapy. J Neuroeng Rehabil. 2020 Apr 21;17(1):53. doi: 10.1186/s12984-020-00672-8.
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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 L Patton, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deficit-fields to reduce error, Deficit-fields to expand range of motion and Deficit-fields to improve function in people with Stroke, run by Shirley Ryan AbilityLab 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 10 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570256, which also lists 1 linked publication.
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 10 Jun 2021.