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Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

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ClinicalTrials.gov Identifier: NCT02277028
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Stroke, Upper Extremity Hemiparesis Behavioral: priming and task specific training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Two Types of Priming for Upper Extremity Hemiparesis
Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Bilateral Priming
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
Behavioral: priming and task specific training
This task specific training protocol has been used in several clinical trials.

Active Comparator: Health Education
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
Behavioral: priming and task specific training
This task specific training protocol has been used in several clinical trials.




Primary Outcome Measures :
  1. Chedoke Arm and Hand Activity Index [ Time Frame: 6-8 weeks ]
    Test of bilateral hand function


Secondary Outcome Measures :
  1. Fugl Meyer Upper Extremity Scale [ Time Frame: 6-8 weeks ]
    Test of unilateral hand/arm function



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277028


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Mary E Stoykov, PhD Rush University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02277028    
Other Study ID Numbers: AOTFIRG13STOYKOV
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Paresis
Neurologic Manifestations
Nervous System Diseases