Clinical trial NCT02277028: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Upper Extremity Hemiparesis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)
timeFrame: value at 6 weeks minus value at baseline
Secondary outcomes:
measure: Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function
timeFrame: value at 6 weeks minus value at baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University
name: Mary E Stoykov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.