AzTrials
AzTrials

StrokeTRACTsNCT05993221

Deconstructing Post Stroke Hemiparesis

An observational study of Stroke, run by Providence VA Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Kelly Rishe, OT contact

401-273-7100

kelly.rishe@va.gov

United States1 site, 1 recruiting
  • Providence VA Medical Center

    Providence, Rhode Island, 02908

    Chona Mcgrenery, 401-273-7100, chona.mcgrenery@va.gov

    Recruiting

Other trials in United States

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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted15 Aug 2023
  2. Study start5 Sep 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Deconstructing Post Stroke Hemiparesis (NCT05993221) | AzTrials