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NCT03517657Completed

Bilateral Priming Plus Task Specific Training for Severe Upper Limb Hemiparesis

Source: ClinicalTrials.gov · Last updated 29 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
80 (actual)
First submitted
18 Apr 2018
Start date
20 Jan 2018
Primary completion date
7 Feb 2024
Lead sponsor
Northwestern University
Diseases
Stroke
NCT number
NCT03517657

What you commit to

  • Study type: Interventional
  • Participants enrolled: 80
  • From 20 Jan 2018 to the primary completion date, 7 Feb 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • metal implant or fragments in head or neck area
  • previous concussion associated with LOC
  • ringing in ears; cochlear implants

Other illness

  • orthopedic conditions of less affected or affected wrist
  • history of seizures, epilepsy or convulsions
  • history of persistent headaches
  • pregnant women
    • Metastatic cancer
    • Other neurological conditions (as in Cerebral Palsy or Parkinson's)

Other

  • MMSE of lower than 21
  • presence of pacemaker or neurostimulator

Who the study is looking for

  • FMUE TEST score of 23 to 40
  • evidence of stroke without involvement of cerebellum at least 6 months prior to enrollment;
  • 0-3 wrist flexion/wrist extension on Modified Ashworth Scale

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Northwestern University and Shirley Ryan Ability Lab
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.