Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

Not Applicable

Completed

• Conditions: Stroke, Upper Extremity Hemiparesis

• Registration Number: NCT02277028
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Results First Submitted: 2020-03-16
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Results First Posted: 2023-10-27
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)	value at 6 weeks minus value at baseline	The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance.

Secondary Outcome Measures

Name	Time	Method
Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function	value at 6 weeks minus value at baseline	Change score between 2-time points (6 weeks follow up - baseline) Change score scale: minimum is 0 and maximum is 66. Higher scores indicate better outcomes.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States