StrokeTRACTsNCT05993221
Deconstructing Post Stroke Hemiparesis
An observational study of Stroke, run by Providence VA Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans who have sustained a unilateral ischemic stroke at least six months prior to recruitment with resulting upper extremity deficit(s).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Providence VA Medical Center
Providence, Rhode Island, 02908
Chona Mcgrenery, 401-273-7100, chona.mcgrenery@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start5 Sep 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David Lin, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993221
- Sponsor's protocol ID
- 1689966
- Acronym
- TRACTs
- Status last verified
- Jun 2025
- First submitted
- 6 Jul 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deconstructing Post Stroke Hemiparesis for Precision Neurorehabilitation
- ClinicalTrials.gov ID
- NCT05993221
- Acronym / sponsor ID
- TRACTs / 1689966
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who have sustained a unilateral ischemic stroke at least six months prior to recruitment with resulting upper extremity deficit(s).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fugl-Meyer Arm Motor Assessment
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
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).
12 secondary outcomes
Edinburgh Handedness Inventory
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Action Research Arm Test (ARAT)
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Modified Ashworth Scale
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Nottingham Sensory Assessment (Erasmus MC)
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
National Institute of Health Stroke Scale
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Montreal Cognitive Assessment (MoCA)
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
History of TBI
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Barthel Index
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Modified Rankin Scale
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Defense and Veterans Pain Rating Scale
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Manual Muscle Testing
Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Providence VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Hebert, BS (401-273-7100 ext. 14351, jennifer.hebert@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Arm Motor Assessment (time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.