Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

A Comparison of Two Types of Priming for Upper Extremity Hemiparesis

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Upper Extremity Hemiparesis
• Intervention / Treatment: Behavioral: priming and task specific training

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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. There are 2 parts to this behavioral intervention. Bilateral priming and task specific training Dosage: 15 minutes of bilateral priming per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. The total of 30 hours of a combination of bilateral priming and task specific training can be completed within 6 weeks. Dosage frequency 2 times per day. Dosage type: Research participant must perform activities with hands as directed by an occupational therapist	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 experimental. There are 2 parts to this behavioral intervention. Computerized health education training and task specific training Dosage: 15 minutes of health education per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. A total of 30 hours of a combination of computerized stroke health education and task specific training can be completed within 6 weeks. Dosage frequency 2 times per day. Dosage type: Research participant must perform computerized health education activities with hands as well as task specific training directed by an occupational therapist	Behavioral: priming and task specific training; This task specific training protocol has been used in several clinical trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)	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.	value at 6 weeks minus value at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function	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.	value at 6 weeks minus value at baseline

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Mary E Stoykov, PhD, Rush University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 24, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimated): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: AOTFIRG13STOYKOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO