Bilateral Priming Plus Task Specific Training for Severe Upper Limb Hemiparesis

NCT03517657 | Completed DMC

• 1 other identifier: STU00205857
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the best treatment for the arm that has been affected by a stroke. The investigators plan to determine if the arm affected by a stroke will improve with a combination of motor priming and motor training. Motor priming provides a warm up for the brain so that the brain and body will better respond to treatment. There are two types of priming in this study. One is called bilateral motor priming which involves using both hands. Bilateral priming requires that the individual make continuous wrist movements in a low-tech gadget called the Exsurgo primer, a piece of equipment in which each hand goes between two plates that are connected together so that the stronger wrist moves the weaker wrist in and out at the same time. The second type of priming includes use of low intensity stimulation for your affected arm. The investigators expect the bilateral priming group will have more improvement. The study team anticipates enrolling approximately 76 individuals with stroke at Northwestern University and Shirley Ryan AbilityLab into this study. Each participant will have 24 visits. Nine visits will be for evaluation and fifteen for therapy. Each visit will be two to three hours depending on the type of visit and tests being done. Participants who are eligible and want to participate in this study will be randomized (selected by chance) to one of the two groups. The possible groups are: 1) bilateral priming plus motor training and 2) electrical stimulation priming and motor training. Participants are not blinded. Evaluation sessions consist of three separate days of testing and will occur at three time points: (1) before treatment starts; (2) after treatment is completed; and (3) 8 weeks later (follow-up evaluation: visits 22-24). There are three motor assessments, the Neuro-QOL (short form), and an evaluation of cortical excitability using TMS. After a stroke, there is often an imbalance of excitability between the affected and less affected parts of the brain. The imbalance will be measured using Transcranial Magnetic Stimulation (TMS), a technique used in neurorehabilitation research. TMS will not be used for treatment. There will also be a grip termination evaluation. This test will determine how long it takes to relax the affected hand after gripping an object.

Conditions

Stroke

Keywords

upper limb; occupational therapy; bilateral priming

Outcome Measures

Primary Outcomes (1)

• Fugl Myer Test of Upper Extremity Function

  Examines upper extremity impairment looking at synergy and isolated movement

  Change in baseline Fugl Myer Score at follow-up (8 weeks after treatment ends)

Study Arms (2)

Bilateral motor priming + Task specific training (BMP + TST)

EXPERIMENTAL

A combination of bilateral motor priming (BMP) plus task specific training (TST) for 30 hours over 5 weeks.

Behavioral: Bilateral Motor Priming + Task Specific Training (BMP + TST)

Control Priming + TST (CP + TST)

ACTIVE COMPARATOR

The control priming is transcutaneous electric stimulation (TENS) set at a low threshold followed by the same task specific training protocol for 30 hours over 5 weeks.

Behavioral: Control Priming + TST (CP + TST)

Interventions

Bilateral Motor Priming + Task Specific Training (BMP + TST) BEHAVIORAL

Priming will always precede task specific training. During bilateral motor priming, the "Rocker" (Exsurgo Bilateral Primer, Aukland, New Zealand) will be used. For the individuals assigned to the bilateral priming group, both hands will be strapped in place in the vertically oriented plates which are attached via a mechanical linkage. They will move both wrists in rhythmic, symmetrical wrist flexion and extension for 15 minutes at a frequency of 1 Hz as cued by a metranome. Subjects do not need to have active flexion and extension of the affected hand as the less affected arm drives the weaker one (through an acutator underneath the surface) in in-phase bilateral symmetrical movement.

Also known as: Active-Passive Bilateral Therapy

Bilateral motor priming + Task specific training (BMP + TST)

Control Priming + TST (CP + TST) BEHAVIORAL

The control priming intervention for the active comparator group will be intermittent cutaneous electric stimulation of the volar aspect of the paretic forearm, using a standard TENS unit delivered for 15 seconds (including 2-second ramp-up, 2-second ramp-down), once per minute, for 15 minutes. Intensity will be minimized

Also known as: Transcutaneous Electric Stimulation

Control Priming + TST (CP + TST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FMUE TEST score of 23 to 40
• evidence of stroke without involvement of cerebellum at least 6 months prior to enrollment;
• wrist flexion/wrist extension on Modified Ashworth Scale

You may not qualify if:

• orthopedic conditions of less affected or affected wrist
• MMSE of lower than 21
• metal implant or fragments in head or neck area
• history of seizures, epilepsy or convulsions
• previous concussion associated with LOC
• ringing in ears; cochlear implants
• history of persistent headaches
• presence of pacemaker or neurostimulator
• pregnant women
• Metastatic cancer
• Other neurological conditions (as in Cerebral Palsy or Parkinson's)

Sponsors & Collaborators

• Northwestern University: lead
• University of Illinois at Chicago: collaborator
• Shirley Ryan AbilityLab: collaborator
• University of Chicago: collaborator

Study Sites (2)

Northwestern University and Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60613, United States

Location

Related Publications (2)

• King EC, Trevarrow M, Urday S, Schauer JM, Corcos DM, Stoykov ME. MEP Status is Not Predictive of Response to Upper Limb Training in People With Chronic, Moderate-Severe Hemiparesis Post-Stroke. Neurorehabil Neural Repair. 2025 Jun;39(6):445-451. doi: 10.1177/15459683251327582. Epub 2025 Mar 25.

  PMID: 40130687 DERIVED

• Stoykov ME, Biller OM, Wax A, King E, Schauer JM, Fogg LF, Corcos DM. Bilateral upper extremity motor priming (BUMP) plus task-specific training for severe, chronic upper limb hemiparesis: study protocol for a randomized clinical trial. Trials. 2022 Jun 22;23(1):523. doi: 10.1186/s13063-022-06465-9.

  PMID: 35733202 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Bone Morphogenetic Proteins; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Daniel M Corcos, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Therapy and Human Movement Sciences

Model Details: Patients are stratified by Fugl Meyer score. After stratification, patients will be randomized to one of two groups

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 7, 2018
• Study Start: January 20, 2018
• Primary Completion: February 7, 2024
• Study Completion: March 30, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)