Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

Stroke Clinical Trial

Official title:

Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634397
• Other study ID #: STUDY00008385
• Secondary ID: R01HD059783-06A1
• Status: Completed
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: September 28, 2023

Study information

• Verified date: April 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 28, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Less-Impaired Arm Training
Participants receive virtual reality and manipulation training in their less impaired arm.
• Contralesional Arm Comparison
Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	University of Southern California	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
Robert L. Sainburg	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline on ABILHAND	Participant reported outcome of difficulty of upper extremity based activities	within 1 week following last treatment session
Primary	Change from baseline on Barthel Index	Measure of functional independence in self care activities	within 1 week following last treatment session
Primary	Change from baseline on Upper-Extremity Fugl-Meyer Assessment	Measure of paretic arm impairment	within 1 week following last treatment session
Secondary	Change from baseline on FIM-motor subscale	Measure of burden of care for self care activities	within 1 week following last treatment session
Secondary	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
Secondary	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