NCT05256563

Brief Summary

More than 30,000 Veterans are hospitalized for stroke each year, and in the critical first months of recovery, at least half are disabled by abnormal 3-D spatial function (spatial neglect). Their self-care, mobility, and ability to return home are severely limited.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Sep 2021Jul 2027

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

February 15, 2022

Last Update Submit

January 30, 2026

Conditions

Spatial NeglectStroke

Outcome Measures

Primary Outcomes (7)

  • Change in functional ability for daily life tasks assessed on the FONE-FIM at 3 months

    Functional performance of daily life tasks will be assessed with the FONE-FIM questionnaire. This variable assesses improvement between baseline and 3 months. The FONE-FIM has has a minimum score of 18 and a maximum score of 126, being 126 the maximum level of independence in daily life activities. Therefore, change can be 0-108 points.

    baseline to 3 months

  • SN severity at baseline

    Catherine Bergego Scale--an examiner-assessed measure of functional performance specific to SN. The score goes from 0 to 30 determining mild (0-10), moderate (11-20) or severe (21-30) spatial neglect.

    baseline

  • Change in functional ability assessed by the Barthel Index at 3 months

    Functional performance of daily life tasks will be assessed with the Barthel Index questionnaire. This is has a minimum score of 0 and a maximum score of 100, with100 the maximum amount of help a person might need to perform daily life activities. Therefore, change at 3 months can be 0-100 points.

    baseline to 3 months

  • Change in functional ability for daily life tasks assessed on the FONE-FIM at 6 months

    Functional performance of daily life tasks will be assessed with the FONE-FIM questionnaire. This variable assesses improvement between baseline and 6 months. The FONE-FIM has has a minimum score of 18 and a maximum score of 126, being 126 the maximum level of independence in daily life activities. Therefore, change can be 0-108 points.

    baseline to 6 months

  • SN severity at 3 months

    Catherine Bergego Scale--an examiner-assessed measure of functional performance specific to SN. The score goes from 0 to 30 determining mild (0-10), moderate (11-20) or severe (21-30) spatial neglect.

    3 months post-baseline

  • SN severity at 6 months

    Catherine Bergego Scale--an examiner-assessed measure of functional performance specific to SN. The score goes from 0 to 30 determining mild (0-10), moderate (11-20) or severe (21-30) spatial neglect.

    6 months post-baseline

  • Change in functional ability assessed by the Barthel Index at 6 months

    Functional performance of daily life tasks will be assessed with the Barthel Index questionnaire. This is has a minimum score of 0 and a maximum score of 100, with100 the maximum amount of help a person might need to perform daily life activities. Therefore, change at 6 months can be 0-100 points.

    baseline to 6 months

Other Outcomes (1)

  • Number of stroke survivors that have evidence of Aiming SN

    baseline

Study Arms (1)

Right brain stroke survivors

People with right brain stroke who are recruited to the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See Inclusion and Exclusion Criteria

You may qualify if:

  • Stroke survivors \>18 years
  • months post-stroke
  • Can undergo testing and give informed consent

You may not qualify if:

  • Other serious
  • Chronic neurological disorders
  • Evidence of other serious strokes
  • Inability to undergo testing or give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anna M. Barrett, MD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 25, 2022

Study Start

September 1, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)