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Deficit Fields for Stroke Recovery

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Deficit-fields to reduce error

Deficit-fields to expand range of motion

Deficit-fields to improve function

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, upper extremity, motor exploration, error augmentation, robotic rehabilitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Deficit-fields to reduce error

Deficit-fields to expand range of motion

Deficit-fields to improve function

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Arm motor recovery scores on the Fugl-Meyer

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

Secondary Outcome Measures

Number of blocks transferred in Box and Blocks Test

Change from baseline in number of blocks transferred during Box and Blocks Test

Modified Ashworth Scale (MAS)

Change from baseline in amount of spasticity in elbow flexors and extensors

Elbow active range of motion (ROM)

Change from baseline measured in degrees for elbow flexion and extension

Chedoke McMaster Stroke Assessment for Hand

Change in baseline in amount of hand motor recovery as measured by Chedoke scale

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

Full Information

NCT ID

NCT02570256

First Posted

October 1, 2015

Last Updated

June 8, 2021

Sponsor

Shirley Ryan AbilityLab

Collaborators

National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT02570256

Brief Title

Deficit Fields for Stroke Recovery

Official Title

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 1, 2013 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shirley Ryan AbilityLab

Collaborators

National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Deficit-fields to reduce error

Arm Type

Experimental

Arm Description

Arm Title

Deficit-fields to expand range of motion

Arm Type

Experimental

Arm Description

Arm Title

Deficit-fields to improve function

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Deficit-fields to reduce error

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Deficit-fields to expand range of motion

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Deficit-fields to improve function

Intervention Description

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.

Primary Outcome Measure Information:

Title

Arm motor recovery scores on the Fugl-Meyer

Description

Change from baseline in arm motor recovery as measured by 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

Secondary Outcome Measure Information:

Title

Number of blocks transferred in Box and Blocks Test

Description

Change from baseline in number of blocks transferred during 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

Title

Modified Ashworth Scale (MAS)

Description

Change from baseline in amount of spasticity in elbow flexors and extensors

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

Title

Elbow active range of motion (ROM)

Description

Change from baseline measured in degrees for elbow flexion and extension

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

Title

Chedoke McMaster Stroke Assessment for Hand

Description

Change in baseline in amount of hand motor recovery as measured by Chedoke scale

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

Title

Time and completion score for Action Research Arm Test (ARAT)

Description

Change in baseline score and time for completion of functional measures as part of 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James L Patton, PhD

Organizational Affiliation

Shirley Ryan AbilityLab

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rehabilitation Institute of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32316977

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.

Results Reference

derived

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Deficit Fields for Stroke Recovery

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