Clinical trial NCT03062930: Remediation of the Non-Paretic Arm in Stroke
Official title: Remediation of the Non-Paretic Arm to Improve Functional Independence in Chronic Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
hemiparesis
lesion hemisphere
ipsilesional deficits
contralesional deficits
rehabilitation
remediation
paretic arm
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Stroke survivors with severe contralesional paresis often have substantial control and coordination deficits in the non-paretic arm. Because this arm must serve as the primary controller, these deficits can be functionally devastating. The investigators now hypothesize that the combination of severe paresis (Upper Extremity Fugl-Meyer Score ≤35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that remediation, focused on the non-paretic arm should improve functional independence. The investigators propose a randomized study design with two tracts, two periods and four assessments. The investigators envision this study as the first step in establishing the basis for a rehabilitation approach that focuses on remediation of BOTH arms, which constitutes a substantial change from current remediation protocols focused only on the contralesional arm.

Detailed description: The investigators previously elaborated hemisphere specific motor deficits in the non-paretic arm of chronic stroke survivors with unilateral hemisphere damage. The investigators showed that these deficits are associated with substantial limitations in performance of activities of daily living (ADL), an effect exacerbated by contralesional paresis due to forced reliance on the non-paretic arm. The investigators now hypothesize that the combination low moderate to severe paresis (Fugl-Meyer Score \< 35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that intense remediation focused on improving the speed, coordination, and accuracy of the non-paretic arm should improve functional independence, as well as improving paretic arm function due to increased participation in daily activities. Unfortunately, the usual standard of care in rehabilitation for survivors with low-moderate to severe paresis tends to focus on task training in essential ADL activities, rather than on intensive remediation. Previous research has shown that non-paretic arm deficits depend on the hemisphere that is damaged by stroke, such that left hemisphere damage (LHD) impairs trajectory features, including speed and smoothness, while right hemisphere damage (RHD) impairs the ability to bring the arm to rest at an accurate and stable position. The investigators have designed a training program to address both of these motor components and to improve the speed and dexterity of the non-paretic arm. The investigators propose a randomized study design with two tracts, two periods and four assessments. Participants will first complete 2 baseline assessments, spaced 3 weeks apart. Following completion of the second assessment, participants will be randomly assigned to one of two tracks: Track 1 will receive three weeks of arm training, followed by 3 weeks of a comparison condition. Participants assigned to track 2 will receive three weeks of the comparison condition, followed by 3 weeks of arm training. Then, all participants will complete an end-of-period assessment, and a follow-up assessment for retention, 3 weeks after completion of the two periods. Pilot results indicate that non-paretic arm training produces substantial improvements in motor performance and functional independence as well as reducing paretic arm impairment. This is an essential first-step in developing a rehabilitation protocol focused on remediating both arms of severely impaired stroke survivors.

Eligibility criteria: Inclusion Criteria:

1. Subjects will be between 21 and 85 years old of either gender
2. Subjects will demonstrate cognitive abilities required to follow commands and engage in the experimental task
3. Subjects will have had a unilateral stroke at least 3 months prior to participation resulting in upper extremity motor deficits

Exclusion Criteria:

1. hospitalization for substance abuse and/or a major psychiatric diagnosis (schizophrenia);
2. non-stroke neurological diseases that may affect ability to perform task or upper limb motor function
3. certain peripheral movement restrictions, such as neuropathy
4. neuroradiological confirmation of concomitant damage to the cerebellum or brain stem or extensive periventricular white matter changes (based on consultation with neuroradiology)

Primary outcomes:
measure: Change in performance time on Jebsen Taylor Hand Function Test
timeFrame: week -3, week 0, week 3, week 6, week 9
Secondary outcomes:
measure: Change in Barthel Index
timeFrame: week -3, week 0, week 3, week 6, week 9
measure: Change in Kinematic analysis
timeFrame: week -3, week 0, week 3, week 6, week 9
measure: Change in Grooved Pegboard
timeFrame: week -3, week 0, week 3, week 6, week 9
measure: Change in Upper Extremity Fugl Meyer Assessment
timeFrame: week -3, week 0, week 3, week 6, week 9
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine; Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Penn State University
name: Robert Sainburg, Phd
role: PRINCIPAL_INVESTIGATOR
References: