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Remediation of the Non-Paretic Arm in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Track 1
Track 2
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, hemiparesis, lesion hemisphere, ipsilesional deficits, contralesional deficits, rehabilitation, remediation, paretic arm

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Penn State College of Medicine; Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Track 1

Track 2

Arm Description

Training of non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks followed by sham condition (playing board games/computer games) for 3 weeks

Sham condition (playing board games/computer games) for 3 weeks followed by training of the non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks

Outcomes

Primary Outcome Measures

Change in performance time on Jebsen Taylor Hand Function Test
test of unimanual arm function on the non-paretic arm

Secondary Outcome Measures

Change in Barthel Index
measure of functional independence
Change in Kinematic analysis
Distance and Direction Errors and Hand Path Straightness on virtual reaching task (non-paretic arm)
Change in Grooved Pegboard
timed measure of dexterity of the non-paretic arm
Change in Upper Extremity Fugl Meyer Assessment
test of paretic arm function

Full Information

First Posted
October 20, 2016
Last Updated
March 26, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03062930
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, hemiparesis, lesion hemisphere, ipsilesional deficits, contralesional deficits, rehabilitation, remediation, paretic arm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Track 1
Arm Type
Active Comparator
Arm Description
Training of non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks followed by sham condition (playing board games/computer games) for 3 weeks
Arm Title
Track 2
Arm Type
Sham Comparator
Arm Description
Sham condition (playing board games/computer games) for 3 weeks followed by training of the non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks
Intervention Type
Behavioral
Intervention Name(s)
Track 1
Other Intervention Name(s)
remediation of non-paretic arm followed by sham training
Intervention Description
Training of non-paretic arm followed by sham condition
Intervention Type
Behavioral
Intervention Name(s)
Track 2
Other Intervention Name(s)
sham condition followed by remediation of non-paretic arm
Intervention Description
Same procedures as track 1, but completed in opposite order, starting with sham condition followed by the non-paretic arm training
Primary Outcome Measure Information:
Title
Change in performance time on Jebsen Taylor Hand Function Test
Description
test of unimanual arm function on the non-paretic arm
Time Frame
week -3, week 0, week 3, week 6, week 9
Secondary Outcome Measure Information:
Title
Change in Barthel Index
Description
measure of functional independence
Time Frame
week -3, week 0, week 3, week 6, week 9
Title
Change in Kinematic analysis
Description
Distance and Direction Errors and Hand Path Straightness on virtual reaching task (non-paretic arm)
Time Frame
week -3, week 0, week 3, week 6, week 9
Title
Change in Grooved Pegboard
Description
timed measure of dexterity of the non-paretic arm
Time Frame
week -3, week 0, week 3, week 6, week 9
Title
Change in Upper Extremity Fugl Meyer Assessment
Description
test of paretic arm function
Time Frame
week -3, week 0, week 3, week 6, week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be between 21 and 85 years old of either gender Subjects will demonstrate cognitive abilities required to follow commands and engage in the experimental task Subjects will have had a unilateral stroke at least 3 months prior to participation resulting in upper extremity motor deficits Exclusion Criteria: hospitalization for substance abuse and/or a major psychiatric diagnosis (schizophrenia); non-stroke neurological diseases that may affect ability to perform task or upper limb motor function certain peripheral movement restrictions, such as neuropathy neuroradiological confirmation of concomitant damage to the cerebellum or brain stem or extensive periventricular white matter changes (based on consultation with neuroradiology)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sainburg, Phd
Organizational Affiliation
Penn State College of Medicine, Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine; Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Scholar Sphere

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Remediation of the Non-Paretic Arm in Stroke

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