StrokeVREANCT01574495
Evaluating Error Augmentation for Neurorehabilitation
A study testing Error Augmentation in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Error Augmentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2012
- 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
- adult (age >18)
- survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
- demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).
Who cannot join
- diffuse or multiple lesion sites or multiple stroke events
- bilateral paresis
- severe spasticity or contracture (Modified Ashworth ≥3
- severe concurrent medical problems
- severe sensory deficits
- cerebellar strokes resulting in severe ataxia
Show all 14Show fewer
- significant shoulder pain
- focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,
- aphasia that would influence the ability to perform the experiment
- cognitive impairment (Mini Mental State Examination < 23/30)
- affective dysfunction that would influence the ability to perform the experiment
- depth perception impairment (< 3 on Stereo Circle Test)
- visual field cut or hemispatial neglect that would influence the ability to participate in the activity
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.
- Conditions
- Stroke
- Being tested
- Error Augmentation
- Keywords
- stroke, error augmentation, arm recovery, massed practice
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Error AugmentationOther
Also called Error Augmentation-Control, Control-Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
| Study group | Role | What they receive |
|---|---|---|
| Error Augmentation-Control | Experimental | Not described Receives: Other: Error Augmentation |
| Control-Error Augmentation | Experimental | Not described Receives: Other: Error Augmentation |
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: Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)
Secondary outcomes (4)
Number of blocks transferred in Box and Blocks Test
Change from baseline in number of blocks transferred during Box and Blocks Test
Measured: same as primary
Time and Quality of movement scores on the Wolf Motor Function Test
Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test
Measured: same as primary
Time scores and Ability scores on the Assessment of Simple Functional Reach Test
Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test
Measured: same as primary (not used for ARM 2)
Quantity and Quality with Motor Activity Log
Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity
Measured: same as primary but added for ARM 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionMar 2012
- Study completionMar 2012
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.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, James Patton, Shirley Ryan AbilityLab
- Investigators
- James Patton, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574495
- Sponsor's protocol ID
- H133E0700 13
- Other IDs
- STU00002311
- Acronym
- VREA
- Status last verified
- Sep 2015
- First submitted
- 28 Feb 2012
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Error Augmentation for Neurorehabilitation
- ClinicalTrials.gov ID
- NCT01574495
- Acronym / sponsor ID
- VREA / H133E0700 13
- Conditions
- Stroke
- Keywords
- stroke, error augmentation, arm recovery, massed practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Jan 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Apr 2012 (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 is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Error Augmentation-Control | Experimental | Other: Error Augmentation |
| Control-Error Augmentation | Experimental | Other: Error Augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (age >18)
- survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
- demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).
Key exclusion criteria (14 listed)
- diffuse or multiple lesion sites or multiple stroke events
- bilateral paresis
- severe spasticity or contracture (Modified Ashworth ≥3
- severe concurrent medical problems
- severe sensory deficits
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 AugmentationAlso: Error Augmentation-Control, Control-Error Augmentationerror augmentation for arm motor recovery in individuals with stroke | Other | Control-Error Augmentation, Error Augmentation-Control |
Primary outcome
Arm motor recovery scores on the Fugl-Meyer
Time frame: Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)
Change from baseline in arm motor recovery as measured by Fugl-Meyer
4 secondary outcomes
Number of blocks transferred in Box and Blocks Test
Time frame: same as primary
Time and Quality of movement scores on the Wolf Motor Function Test
Time frame: same as primary
Time scores and Ability scores on the Assessment of Simple Functional Reach Test
Time frame: same as primary (not used for ARM 2)
Quantity and Quality with Motor Activity Log
Time frame: same as primary but added for ARM 2
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 24 Sep 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Error Augmentation 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 3 inclusion and 14 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 24 Sep 2015. 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: Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)). 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 Sep 2015.