Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

NCT ID: NCT02277028

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2016-04-30

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.

Conditions

Stroke, Upper Extremity Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

priming and task specific training

Intervention Type: BEHAVIORAL

This task specific training protocol has been used in several clinical trials.

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

Group Type: ACTIVE_COMPARATOR

priming and task specific training

Intervention Type: BEHAVIORAL

This task specific training protocol has been used in several clinical trials.

Interventions

priming and task specific training

This task specific training protocol has been used in several clinical trials.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary E Stoykov, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33110623 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31609714 (View on PubMed)

Other Identifiers

AOTFIRG13STOYKOV

Identifier Type: -

Identifier Source: org_study_id