Deconstructing Post Stroke Hemiparesis (TRACTs)

Deconstructing Post Stroke Hemiparesis for Precision Neurorehabilitation

TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into distinct components and relate these components to brain anatomy and physiology.

Study Overview

• Status: Recruiting
• Conditions: Stroke

Detailed Description

Veterans will be recruited through the Providence Veterans Affairs Medical Center and will have research visits at the Providence VA Center for Neurorestoration and Neurotechnology (CfNN, centerforneuro.org). The research visits will span two to three days. The study will involve motor outcome measures, magnetic resonance imaging of the brain, and transcranial magnetic stimulation. The goal of this study is to associate post-stroke deficits of the upper extremity with brain anatomy and physiology.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Kelly Rishe, OT; Phone Number: 401-273-7100; Email: kelly.rishe@va.gov
• Study Contact Backup: Name: Jennifer Hebert, BS; Phone Number: 14351 401-273-7100; Email: jennifer.hebert@va.gov

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Recruiting
      • Providence VA Medical Center
      • Contact: Chona Mcgrenery; Phone Number: 401-273-7100; Email: chona.mcgrenery@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Veterans who have sustained a unilateral ischemic stroke at least six months prior to recruitment with resulting upper extremity deficit(s).

Description

Inclusion Criteria:

• Diagnosis of a unilateral ischemic stroke occurring >6 months prior as documented in medical chart
• Upper extremity motor impairment as measured by Fugl-Meyer Upper Extremity Assessment ≤60
• Ability to follow simple instructions in English

Exclusion Criteria:

• Greater than moderate difficulty using the arm and hand pre-dating the stroke as assessed by the questions adapted from the QuickDASH outcome measure score on any question >= 3, which measures physical function and symptoms in people with difficulty using the arm and hand.
• Visual or auditory disorders resulting in the inability to see or hear, respectively, the stimuli presented as part of research sessions
• Inability to maintain a seated position for at least one hour
• Standard MRI exclusion (e.g., significant claustrophobia or inability to tolerate loud noises, cardiac pacemaker (unless MRI-safe), implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord)
• Standard (single-pulse) TMS exclusion which include (in addition to those listed for MRI) pregnancy/lactation/planning to become pregnant during the study, seizure disorder, and primary or secondary CNS tumors

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Arm Motor Assessment	This test provides information about the level of upper extremity motor impairment after stroke. It consists of a 33-item assessment, which provides a global assessment of upper extremity motor impairment. A rater observes 30 voluntary upper extremity motions, two tendon tap responses, and provides an ordinal rating (2 = near normal ability/response, 1 = partial ability, 0 = unable to perform/no response). The Fugl-Meyer Upper Extremity scale has excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94-0.99), and internal consistency (0.97).	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Handedness Inventory	This screener is used to identify the handedness of participants prior to stroke by asking them which hand they typically use to complete activities of daily living, such as writing, throwing a ball, cutting paper with scissors, brushing teeth, and eating with a spoon. Participants can answer if they would use strictly their right hand, right more than left, both equally, left more than right, or strictly their left hand. Participants are then categorized as left-handed, ambidextrous, or right-handed.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Action Research Arm Test (ARAT)	This test is used to assess upper limb performance post-stroke by measuring coordination, dexterity, and functioning. Participants are asked to complete tasks grouped into four categories - gross movement, grasp, grip, and pinch. Task performance is rated on a four point scale, in which 0 represents no movement and 3 represents normal movement. The Action Research Arm Test has demonstrated an inter-rater reliability between 0.996-0.998.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Modified Ashworth Scale	This test is used to assess spasticity at different joints of the upper extremity. The test will be performed at the shoulder, elbow, forearm, wrist, and digits. The six point scale will indicate presence of the abnormal increase in muscle tone, ranging from 0 = no increase in tone to 4 = affected part in rigid flexion and extension. Higher scores on this assessment mean worse outcomes.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Nottingham Sensory Assessment (Erasmus MC)	This test is used to understand sensory deficits of the upper extremity. Participants are exposed to distinct stimuli and asked to describe if the object is sharp or blunt and the location of the stimulus. A rater will determine if the reported sensation was absent, impaired, or normal.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
National Institute of Health Stroke Scale	This test provides information about overall stroke severity. The test includes a series of different questions which allow for the assessment of level of consciousness, vision, facial, arm, and leg motor weakness, sensation, coordination, and language expression and reception. Score range from 0 to 42. Higher scores on this assessment mean worse outcomes.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Montreal Cognitive Assessment (MoCA)	This test is used to assess cognitive dysfunction by testing multiple different cognitive domains including attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 30 with higher scores meaning better cognitive outcome.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Patient Health Questionnaire 9 (PHQ-9)	This questionnaire is used to screen, diagnose, and monitor post stroke depression. The questionnaire includes a series of questions which allow a participant to self-report how often he/she has been experiencing symptoms of depression. Scores range from 0 to 27 with higher scores meaning worse depression.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
History of TBI	This questionnaire is used to collect information about the participant's injury history to his/her head. Participants are asked how many head injuries they have sustained, if any of these events led to loss of consciousness, and a description of their worst head injury.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Barthel Index	This test provides information about the participant's level of independence in performing activities of daily living (ADLs). The test includes a series of questions which can be asked of the participant or a caregiver. Scores range from 0 to 100 with higher scores meaning better outcome.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Modified Rankin Scale	This scale is used to measure the degree of disability based on functional status. The scale involves a series of questions asked to determine the degree of disability a participant is experiencing at the current timepoint. Scores range from 0 to 6 with higher scores meaning worse outcome.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Defense and Veterans Pain Rating Scale	This scale is used to measure a participant's impression of the pain he/she is feeling at the time of assessment. The participant is asked to rate the pain on a scale of 0 to 10, with 0 indicating no pain and 10 being "as bad as it could be".	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Manual Muscle Testing	This assessment is used to measure the strength of the participant's muscles in his/her upper extremities. Participants are asked to maximally contract these muscles and the force produced is recorded by a dynamometer.	Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

Collaborators and Investigators

• Sponsor: Providence VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Paresis
• Other Study ID Numbers: 1689966

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No