Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Less-Impaired Arm Training
* Behavioral: Contralesional Arm Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neuroradiological confirmation of unilateral brain damage with residual contralesional upper-extremity weakness deficits in ipsilesional arm performance assessed by the JTHFT 6+ months post stroke Demonstrates cognitive abilities Exclusion Criteria: a history of: neurological disease other than stroke (e.g., head trauma) a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder), hospital admission for substance abuse peripheral disorders affecting sensation or movement of the upper extremities, including pain or arthritis currently taking prescription drugs with known sedative properties that are interfering with sensory-motor function significant joint pain that is activity limiting bilateral stroke

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less-Impaired Arm Training<br>Intervention condition includes therapy of the less-impaired (ipsilesional) arm. | Behavioral: Less-Impaired Arm Training<br>* Participants receive virtual reality and manipulation training in their less impaired arm.<br>|
| Sham Comparator: Contralesional Arm Comparison<br>Comparison control condition includes therapy of the paretic (contralesional) arm. | Behavioral: Contralesional Arm Comparison<br>* Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.<br>* Other names: sham condition;|

What is the study measuring?
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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 |