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Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

Primary Purpose

Stroke, Upper Extremity Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
priming and task specific training
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Upper Extremity Hemiparesis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have survived a unilateral stroke at least six months prior to enrollment
  • Fugl Meyer Upper Extremity Score between 22-38.

Exclusion Criteria:

  • No individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilateral Priming

Health Education

Arm Description

Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes

The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes

Outcomes

Primary Outcome Measures

Chedoke Arm and Hand Activity Index
Test of bilateral hand function

Secondary Outcome Measures

Fugl Meyer Upper Extremity Scale
Test of unilateral hand/arm function

Full Information

First Posted
October 24, 2014
Last Updated
May 23, 2016
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02277028
Brief Title
Bilateral Priming for Upper Extremity Hemiparesis in Older Adults
Official Title
A Comparison of Two Types of Priming for Upper Extremity Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke.
Detailed Description
Techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. The purpose of these techniques is to prime the cortex prior to training. The priming techniques previously described in the literature include medication (i.e. amphetamines), transcranial electric or magnetic stimulation, and manipulation of somatosensory input. Here, the investigators examine a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. In this project, the investigators intend to compare bilateral upper limb priming with task specfiic training to a health care education website program followed by the same task specific training as the experimental group.This active comparator (health care education) will receive stroke related health education via a website from the American Heart Association. Transcranial Magnetic Stimulation willl include measurement of transcallosal inhibition persistence from the affected hemisphere to the less affected hemisphere and vice versa ( less affected to affected). The investigators expect the bilateral priming group to have greater changes in transcranial magnetic stimulation measures and greater improvements in behavioral measures at all time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral Priming
Arm Type
Experimental
Arm Description
Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. The priming (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total priming for one day is 30 minutes. Total task specific training for one day is 90 minutes
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as above. The health education (15 minutes) will be following by task specific training (45 minutes). Subjects will then have a break (betw. 30-60 minutes) and then repeat the above. Total time on health education website for one day is 30 minutes. Total task specific training for one day is 90 minutes
Intervention Type
Behavioral
Intervention Name(s)
priming and task specific training
Intervention Description
This task specific training protocol has been used in several clinical trials.
Primary Outcome Measure Information:
Title
Chedoke Arm and Hand Activity Index
Description
Test of bilateral hand function
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
Fugl Meyer Upper Extremity Scale
Description
Test of unilateral hand/arm function
Time Frame
6-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have survived a unilateral stroke at least six months prior to enrollment Fugl Meyer Upper Extremity Score between 22-38. Exclusion Criteria: No individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Stoykov, PhD
Organizational Affiliation
Rush University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33110623
Citation
King EC, Doherty M, Corcos D, Stoykov ME. Examining recruitment feasibility and related outcomes in adults post-stroke. Pilot Feasibility Stud. 2020 Oct 24;6:160. doi: 10.1186/s40814-020-00696-w. eCollection 2020.
Results Reference
derived
PubMed Identifier
31609714
Citation
Stoykov ME, King E, David FJ, Vatinno A, Fogg L, Corcos DM. Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study. Restor Neurol Neurosci. 2020;38(1):11-22. doi: 10.3233/RNN-190943.
Results Reference
derived

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Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

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