Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

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

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

• Principal Investigator: Mary E Stoykov, PhD; Rush University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT02277028
• Other Study ID Numbers: AOTFIRG13STOYKOV
• First Posted: October 28, 2014
• Last Update Posted: May 25, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Paresis; Neurologic Manifestations; Nervous System Diseases