Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

NCT ID: NCT03634397

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-02
• Study Completion Date: 2024-08-05

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Less-Impaired Arm Training

Intervention condition includes therapy of the less-impaired (ipsilesional) arm.

Group Type: EXPERIMENTAL

Less-Impaired Arm Training

Intervention Type: BEHAVIORAL

Participants receive virtual reality and manipulation training in their less impaired arm.

Contralesional Arm Comparison

Comparison control condition includes therapy of the paretic (contralesional) arm.

Group Type: SHAM_COMPARATOR

Contralesional Arm Comparison

Intervention Type: BEHAVIORAL

Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.

Interventions

Less-Impaired Arm Training

Participants receive virtual reality and manipulation training in their less impaired arm.

Intervention Type: BEHAVIORAL

Contralesional Arm Comparison

Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.

Intervention Type: BEHAVIORAL

Other Intervention Names

sham condition

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Robert L. Sainburg

OTHER

Sponsor Role: lead

Responsible Party

Robert L. Sainburg

Professor of Kinesiology and Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert L Sainburg, Phd, OTR

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Carolee J Winstein, PhD,PT

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Penn State College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35413856 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HD059783-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008385

Identifier Type: -

Identifier Source: org_study_id