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OpenTrials
Completed

NCT Number: NCT02570256

Deficit Fields for Stroke Recovery

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

    Change from baseline measured in degrees for elbow flexion and extension

  4. 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

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

  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

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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

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

Registry information

Official study title

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Oct 7, 2015
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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