Deconstructing Post Stroke Hemiparesis

NCT05993221 | Recruiting

• 1 other identifier: 1689966
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (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).

  Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

Secondary Outcomes (12)

• Edinburgh Handedness Inventory

  Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

• Action Research Arm Test (ARAT)

  Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

• Modified Ashworth Scale

  Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

• Nottingham Sensory Assessment (Erasmus MC)

  Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

• National Institute of Health Stroke Scale

  Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Providence VA Medical Center: lead

Study Sites (1)

Providence VA Medical Center

Providence, Rhode Island, 02908, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jennifer Hebert, BS

CONTACT

401-273-7100; jennifer.hebert@va.gov

Kelly Rishe, OT

CONTACT

401-273-7100; kelly.rishe@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Core Investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 15, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)