Clinical trial NCT02570256: Deficit Fields for Stroke Recovery
Official title: Error-enhanced Learning & Recovery in 2 & 3 Dimensions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
upper extremity
motor exploration
error augmentation
robotic rehabilitation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2015-10-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Arm motor recovery scores on the Fugl-Meyer
timeFrame: 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:
measure: Number of blocks transferred in Box and Blocks Test
timeFrame: 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
measure: Modified Ashworth Scale (MAS)
timeFrame: 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
measure: Elbow active range of motion (ROM)
timeFrame: 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
measure: Chedoke McMaster Stroke Assessment for Hand
timeFrame: 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
measure: Time and completion score for Action Research Arm Test (ARAT)
timeFrame: 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
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: James L Patton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.