Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

• ClinicalTrials.gov Identifier: NCT03634397
• Recruitment Status: Recruiting
• First Posted: August 16, 2018
• Last Update Posted: May 17, 2023
• Sponsor: Robert L. Sainburg
• 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

Study Description

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 less-impaired arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired 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 less-impaired 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 less-impaired 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 less-impaired 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 less-impaired 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 less-impaired 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 less-impaired 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: January 31, 2024
• Estimated Study Completion Date: March 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline on Jebsen-Taylor Hand Function Test Test [ Time Frame: within 1 week following last treatment session ]
   Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living.
2. Change from baseline on ABILHAND [ Time Frame: within 1 week following last treatment session ]
   Participant reported outcome of difficulty of upper extremity based activities
3. Change from baseline on Barthel Index [ Time Frame: within 1 week following last treatment session ]
   Measure of functional independence in self care activities
4. Change from baseline on Upper-Extremity Fugl-Meyer Assessment [ Time Frame: within 1 week following last treatment session ]
   Measure of paretic arm impairment

Secondary Outcome Measures :

1. Change from baseline on FIM-motor subscale [ Time Frame: within 1 week following last treatment session ]
   Measure of burden of care for self care activities
2. Change from baseline on Work Space Area [ Time Frame: within 1 week following last treatment session ]
   Kinematic measure of active range of motion of the paretic arm
3. Change from baseline on Position Variability [ Time Frame: within 1 week following last treatment session ]
   Measure of kinematic variability in reaching movements, early and late in the movement

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. neuroradiological confirmation of unilateral brain damage with residual contralesional upper-extremity weakness
2. deficits in ipsilesional arm performance assessed by the JTHFT
3. 6+ months post stroke
4. Demonstrates cognitive abilities

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
7. bilateral stroke

Contacts and Locations

Contacts

Contact: Candice Maenza, MS; 717-531-0003 ext 283146; cchopick@pennstatehealth.psu.edu

Locations

United States, California

University of Southern California; Recruiting

Los Angeles, California, United States, 90089

Contact: Joseph Saba, BS 323-442-1196 saba.joseph97@gmail.com

Principal Investigator: Carolee Winstein, PhD, PT

United States, Pennsylvania

Penn State College of Medicine; Recruiting

Hershey, Pennsylvania, United States, 17033

Contact: Candice Maenza, MS 717-531-0003 ext 283146 Cmaenza@pennstatehealth.psu.edu

Principal Investigator: Robert L Sainburg, PhD, OTR

Sub-Investigator: David C Good, MD

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

• 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:

Study Protocol and Statistical Analysis Plan  [PDF] March 20, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Maenza C, Sainburg RL, Varghese R, Dexheimer B, Demers M, Bishop L, Jayasinghe SAL, Wagstaff DA, Winstein C; IPSI Investigative Team. Ipsilesional arm training in severe stroke to improve functional independence (IPSI): phase II protocol. BMC Neurol. 2022 Apr 12;22(1):141. doi: 10.1186/s12883-022-02643-z.

• 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
• Last Update Posted: May 17, 2023
• Last Verified: May 2023

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/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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