Clinical trial NCT03634397: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Penn State University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-08-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two groups. One group (treatment group) receives remediation therapy of the less impaired arm while the control group receives paretic arm therapy.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
measure: Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
measure: Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
measure: Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Secondary outcomes:
measure: Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
measure: Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics)
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
measure: Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1
timeFrame: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Robert L Sainburg, Phd, OTR
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Carolee J Winstein, PhD,PT
role: PRINCIPAL_INVESTIGATOR
References:
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.