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): 58
• Phase: Not Applicable

Contacts and Locations

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 in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1	Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living. The test includes 7 timed (seconds) activities (possible 0-120 seconds each); the analysis excludes the writing component, therefore it includes 6 of the 7 original JTHFT components. Faster performance yields lower scores (time). There were 2 baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.	Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1	Participant reported outcome of difficulty of upper extremity based activities. Scores are transformed to logit scores. The items ranged on the interval scale from -2.18 to 1.72 log-odds units, called 'logits', with higher logit values indicating more difficult activities. Deltas of logits from baseline 2 to post test 1 are reported. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores. Results do not include covariates.	Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1	Measure of functional independence in self care activities scored from 0-100 with higher scores indicating more functional independence. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.	Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1	Upper-Extremity Measure of paretic arm impairment out of 66 possible points with higher scores indicating more movement, and 0 indicating no functional movement in the arm. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.	Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components	Each item on the FIM is scored on a 7-point Likert scale, and the score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). Analysis includes 6 sub-components of the FIM, which are the self care components (Eating, Grooming, Bathing, Dressing upper body, Dressing lower body, and toileting) (possible 42 points). Higher scores indicate more independence. There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.	Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics)	Workspace area is a kinematic measure of active range of motion, which we measured on the paretic (contralesional) arm. This was calculated by computing the area of the ellipse (measured in centimeters) formed by the major and minor axis of the contralesional arm trajectory on each trial. The major axis was defined as the largest distance between any two points in the handpath, while the minor axis was defined as the largest distance, perpendicular to the major axis. Values were averaged within subjects over all trials for each evaluation (i.e. BL2 and PT1), then group and evaluation averages and standard deviations were calculated from these values. There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores. These values do not include covariates.	Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1	Positional variability is a measure of kinematic variability in reaching movement. This was measured at the participants max reaching velocity and their end position. This was calculated by taking the distance (cm) from the fingertips location at peak velocity/end position on a given trial from its mean location at peak velocity/end position across all trials, for each target. Values were averaged within subjects over all trials for each evaluation (i.e. BL2 and PT1), then group and evaluation averages and standard deviations were calculated from these values. There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores or covariates.	Baseline 2 to Post Test 1 (up to 2 weeks post 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): February 22, 2024
• Study Completion (Actual): August 5, 2024

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 (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular 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