Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Less-Impaired Arm Training
Contralesional Arm Comparison
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- University of Southern CaliforniaRecruiting
- Penn State College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Less-Impaired Arm Training
Contralesional Arm Comparison
Arm Description
Intervention condition includes therapy of the less-impaired (ipsilesional) arm.
Comparison control condition includes therapy of the paretic (contralesional) arm.
Outcomes
Primary Outcome Measures
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.
Change from baseline on ABILHAND
Participant reported outcome of difficulty of upper extremity based activities
Change from baseline on Barthel Index
Measure of functional independence in self care activities
Change from baseline on Upper-Extremity Fugl-Meyer Assessment
Measure of paretic arm impairment
Secondary Outcome Measures
Change from baseline on FIM-motor subscale
Measure of burden of care for self care activities
Change from baseline on Work Space Area
Kinematic measure of active range of motion of the paretic arm
Change from baseline on Position Variability
Measure of kinematic variability in reaching movements, early and late in the movement
Full Information
NCT ID
NCT03634397
First Posted
July 3, 2018
Last Updated
May 16, 2023
Sponsor
Robert L. Sainburg
Collaborators
University of Southern California, Penn State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03634397
Brief Title
Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
Official Title
Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert L. Sainburg
Collaborators
University of Southern California, Penn State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The outcome assessor will assess all participants and be unaware of the participants' group assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Less-Impaired Arm Training
Arm Type
Experimental
Arm Description
Intervention condition includes therapy of the less-impaired (ipsilesional) arm.
Arm Title
Contralesional Arm Comparison
Arm Type
Sham Comparator
Arm Description
Comparison control condition includes therapy of the paretic (contralesional) arm.
Intervention Type
Behavioral
Intervention Name(s)
Less-Impaired Arm Training
Intervention Description
Participants receive virtual reality and manipulation training in their less impaired arm.
Intervention Type
Behavioral
Intervention Name(s)
Contralesional Arm Comparison
Other Intervention Name(s)
sham condition
Intervention Description
Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Primary Outcome Measure Information:
Title
Change from baseline on Jebsen-Taylor Hand Function Test Test
Description
Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living.
Time Frame
within 1 week following last treatment session
Title
Change from baseline on ABILHAND
Description
Participant reported outcome of difficulty of upper extremity based activities
Time Frame
within 1 week following last treatment session
Title
Change from baseline on Barthel Index
Description
Measure of functional independence in self care activities
Time Frame
within 1 week following last treatment session
Title
Change from baseline on Upper-Extremity Fugl-Meyer Assessment
Description
Measure of paretic arm impairment
Time Frame
within 1 week following last treatment session
Secondary Outcome Measure Information:
Title
Change from baseline on FIM-motor subscale
Description
Measure of burden of care for self care activities
Time Frame
within 1 week following last treatment session
Title
Change from baseline on Work Space Area
Description
Kinematic measure of active range of motion of the paretic arm
Time Frame
within 1 week following last treatment session
Title
Change from baseline on Position Variability
Description
Measure of kinematic variability in reaching movements, early and late in the movement
Time Frame
within 1 week following last treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candice Maenza, MS
Phone
717-531-0003
Ext
283146
Email
cchopick@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Sainburg, Phd, OTR
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolee J Winstein, PhD,PT
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Saba, BS
Phone
323-442-1196
Email
saba.joseph97@gmail.com
First Name & Middle Initial & Last Name & Degree
Carolee Winstein, PhD, PT
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice Maenza, MS
Phone
717-531-0003
Ext
283146
Email
Cmaenza@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Robert L Sainburg, PhD, OTR
First Name & Middle Initial & Last Name & Degree
David C Good, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://scholarsphere.psu.edu/
Citations:
PubMed Identifier
35413856
Citation
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.
Results Reference
derived
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Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
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