Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Less-Impaired Arm Training; Behavioral: Contralesional Arm Comparison

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candice Maenza, MS; Phone Number: 283146 717-531-0003; Email: cchopick@pennstatehealth.psu.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: sham condition

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Robert L. Sainburg
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Southern California; Penn State University
• Investigators: Principal Investigator: Robert L Sainburg, Phd, OTR, Penn State University; Principal Investigator: Carolee J Winstein, PhD,PT, University of Southern California

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2019
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STUDY00008385; R01HD059783-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Within one year of study completion, available for a minimum of one year.
• IPD Sharing Access Criteria: The web address is open to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No