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Predictors of Response in Chronic Stroke (SRT5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283253
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
VA Pittsburgh Healthcare System

Tracking Information
First Submitted Date  ICMJE January 21, 2020
First Posted Date  ICMJE February 25, 2020
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE October 22, 2019
Estimated Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
A change in the Fugl-Meyer Upper Extremity Assessment score [ Time Frame: Immediately following the 12-week intervention ]
The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2020)
  • A change in motor evoked potential during Transcranial Magnetic Stimulation of the motor cortex [ Time Frame: Immediately following the 12-week intervention ]
    TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) to assess change in the motor evoked potential (MEP) of the arm muscles.
  • A change in brain connections assessed via MRI of the brain [ Time Frame: Immediately following the 12-week intervention ]
    A detailed analysis of the MRI data will examine individual interregional connections to determine whether any of them are more sensitive to the intervention than others.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Predictors of Response in Chronic Stroke
Official Title  ICMJE Neurophysiological and Kinematic Predictors of Response in Chronic Stroke
Brief Summary This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significant change in impairment at the end of a robot assisted therapy intervention.The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).
Detailed Description

After informed consent, a baseline neurological exam, medical records review, MRI of the brain, TMS, questionnaires, cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing will occur in the first 4-6 weeks of participation including two separate sessions approximately 1 week a part to examine arm strength, range of motion, and ability to perform functional tasks, with one additional session if needed to verify stability between results. Additionally, one robot evaluation will be completed.

The intervention phase consists of 12 weeks of robot and transition to task arm exercise training (TTT). Interventions will occur approximately 3 times per week for 12 weeks for a total of 36 visits. Additional time and visits will be allowed with visits occurring 4 times per week or up to 6 additional weeks (not to exceed 18 weeks) if scheduling conflicts arise. The intervention sessions will be one hour in duration.

During the hour-long intervention, 45 minutes of robotic intervention will be followed by 15 minutes of TTT. The training will be sequential with 12 sessions focused on the wrist, followed by 12 sessions on the shoulder-elbow and the final 12 sessions alternating between the wrist and elbow-shoulder.

After the final training session, subjects will return after a 12 week retention period. At various time points during and after the intervention phase there will be additional arm function testing, robot evaluations, questionnaires, MRI and TMS sessions for re-assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
One-arm, multiple baseline sequential, cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Cardiovascular Diseases
Intervention  ICMJE Device: Robot + TTT exercise
The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
Study Arms  ICMJE Experimental: Robot + TTT Exercise
All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.
Intervention: Device: Robot + TTT exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2020)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 28, 2020
Estimated Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
  • Stroke onset at least 6 months before enrollment
  • Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45)
  • Be medically stable to participate in the study
  • Be English speaking

Exclusion Criteria:

  • Unable to give informed consent
  • Have a serious complicating medical illness that would preclude participation.
  • Contractures or orthopedic problems limiting range of joint motion in the potential study arm
  • Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
  • Botulinum toxin to study arm within four months of study enrollment or if received during the study period
  • Unable to comply with requirements of the study
  • Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions
  • Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions
  • Have a serious complicating medical illness that would preclude participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Boos, MS 4126484179 amy.boos@pitt.edu
Contact: George Wittenberg, PhD 4126484178 GEOWITT@PITT.EDU
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04283253
Other Study ID Numbers  ICMJE Pro00003161
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

A de-identified, anonymized dataset will be created and shared. Where practicable, sharing should take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or reidentify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.

Datasets will be made available to the public following appropriate approvals for disclosure criteria.

Every effort will be made to protect personal privacy and the confidentiality of private information collected for research purposes. This particular dataset will be de-identified and the minimum amount of information necessary to achieve the objectives of the research proposed will be collected and shared.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party VA Pittsburgh Healthcare System
Study Sponsor  ICMJE VA Pittsburgh Healthcare System
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: George Wittenberg, PhD University of Pittsburgh
PRS Account VA Pittsburgh Healthcare System
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP