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Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634397
Recruitment Status : Suspended (Temporarily suspended due to Pandemic)
First Posted : August 16, 2018
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
University of Southern California
Penn State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Robert L. Sainburg, Milton S. Hershey Medical Center

Brief Summary:
This study will test the hypothesis that the combination of low-moderate to severe motor deficits in the paretic arm and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the non-paretic arm should improve functional independence.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Less-Impaired Arm Training Behavioral: Contralesional Arm Comparison Not Applicable

Detailed Description:
We previously characterized hemisphere-specific motor control deficits in the non-paretic arm of unilaterally lesioned stroke survivors. Our preliminary data indicate these deficits are substantial and functionally limiting in patients with severe paresis. We have specifically designed an intervention to remediate the hemisphere-specific deficits in the non-paretic arm, using a virtual-reality platform, and then follow this training with manipulation training of a variety of real objects, designed to facilitate generalization and transfer to functional behaviors encountered in the natural environment. We propose a 2-site, two-group randomized intervention with a treatment group, which will receive unilateral training of the non-paretic arm, through our Virtual Reality and Manipulation Training (VRMT) protocol. This intervention protocol is grounded in the premise that targeted remediation of fundamental control deficits exhibited by the non-paretic arm will generalize and transfer beyond practiced tasks to performance of activities of daily living (ADL). This approach contrasts with the more pragmatic approach of task-specific training of essential ADL's, which is limited in scope, more cumbersome, and ignores known fundamental motor control deficits. Our control group will receive conventional intervention, guided by recently released practice guidelines for upper limb intervention in adult stroke. The impact of the proposed research is that we address persistent functional performance deficits in chronic stroke patients with severe paresis, who's non-paretic arm impairments are generally ignored in most current rehabilitation protocols. Our first aim addresses the overall effectiveness of this intervention, relative to our control group: To determine whether non-paretic arm VRMT in chronic stroke survivors with severe paresis will produce durable improvements in non-paretic arm motor performance that will generalize to improve functional activities and functional independence to a greater extent than conventional therapy focused on the paretic arm. Our second aim focuses on the mechanistic basis of potential training-related improvements in motor performance: To determine whether intervention-induced improvements in non-paretic arm performance are associated with improvements in hemisphere-specific reaching kinematics. Finally, our third aim monitors for potential negative effects of our experimental intervention on paretic arm impairment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to one of two groups. One group (treatment group) receives remediation therapy of the non-paretic arm while the control group receives paretic arm therapy.
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will assess all participants and be unaware of the participants' group assignment.
Primary Purpose: Treatment
Official Title: Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
Experimental: Less-Impaired Arm Training
Intervention condition includes therapy of the less-impaired (ipsilesional) arm.
Behavioral: Less-Impaired Arm Training
Participants receive virtual reality and manipulation training in their less impaired arm.

Sham Comparator: Contralesional Arm Comparison
Comparison control condition includes therapy of the paretic (contralesional) arm.
Behavioral: Contralesional Arm Comparison
Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Other Name: sham condition




Primary Outcome Measures :
  1. Change from baseline on Jebsen Taylor Hand Function Test at multiple timepoints Test [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living.

  2. Change from baseline on ABILHAND at multiple timepoints [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Patient reported outcome of difficulty of upper extremity based activities

  3. Change from baseline on Barthel Index at multiple timepoints [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Measure of functional independence in self care activities

  4. Change from baseline on Upper-Extremity Fugl-Meyer Assessment at multiple timepoints [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Measure of paretic arm impairment


Secondary Outcome Measures :
  1. Change from baseline on FIM-motor subscale at multiple timepoints [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Measure of burden of care for self care activities

  2. Change from baseline on Work Space Area at multiple timepoints [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Kinematic measure of active range of motion of the paretic arm

  3. Change from baseline on Position Variability at multiple timepoints [ Time Frame: 2 baseline pre-tests (1 week apart pre-treatment), 3 post tests: 1) within 1 week following last treatment session, 2) two weeks post treatment, 3) Six months) ]
    Measure of kinematic variability in reaching movements, early and late in the movement



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neuroradiological confirmation of unilateral brain damage with residual upper-extremity weakness
  • deficits in ipsilesional arm performance

Exclusion Criteria:

a history of:

  1. neurological disease other than stroke (e.g., head trauma)
  2. a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder),
  3. hospital admission for substance abuse
  4. peripheral disorders affecting sensation or movement of the upper extremities, including pain or arthritis
  5. currently taking prescription drugs with known sedative properties that are interfering with sensory-motor function
  6. significant joint pain that is activity limiting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634397


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90089
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Robert L. Sainburg
University of Southern California
Penn State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Robert L Sainburg, Phd, OTR Penn State University
Principal Investigator: Carolee J Winstein, PhD,PT University of Southern California
  Study Documents (Full-Text)

Documents provided by Robert L. Sainburg, Milton S. Hershey Medical Center:
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Responsible Party: Robert L. Sainburg, Professor of Kinesiology and Neurology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03634397    
Other Study ID Numbers: STUDY00008385
R01HD059783-06A1 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified research data (functional outcome measures) generated by the project will be shared through ScholarSphere (https://scholarsphere.psu.edu/), the repository service that both the University Libraries and Information Technology Services administer at Penn State. Researchers will be able to access the data via ScholarSphere, which ensures persistent access to deposited content. The data will be discoverable via Google and other major search engines, as well as by request to Dr. Sainburg or Dr. Winstein.
Time Frame: Within one year of study completion, available for a minimum of one year.
Access Criteria: The web address is open to the public.
URL: https://scholarsphere.psu.edu/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases