Deficit Fields for Stroke Recovery

NCT02570256 | Completed

• 2 other identifiers: RehabilitationIC2R01NS053606-05A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; upper extremity; motor exploration; error augmentation; robotic rehabilitation

Outcome Measures

Primary Outcomes (1)

• Arm motor recovery scores on the Fugl-Meyer

  Change from baseline in arm motor recovery as measured by Fugl-Meyer

  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

  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)

  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)

  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

  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)

  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

Study Arms (3)

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.

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).

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.

Behavioral: Deficit-fields to improve function

Interventions

Deficit-fields to reduce error BEHAVIORAL

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 reduce error

Deficit-fields to expand range of motion BEHAVIORAL

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 expand range of motion

Deficit-fields to improve function BEHAVIORAL

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.

Deficit-fields to improve function

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 32316977 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James L Patton, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 7, 2015
• Study Start: May 1, 2013
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 10, 2021

Record last verified: 2018-10

Locations

US (1)