NCT03402906

Brief Summary

Spatial neglect may occur in patients who have had a stroke. People with spatial neglect often pay much more attention to one side of the body while ignoring the other side, even though they have no difficulty seeing. The purpose of this study is to evaluate the impact on stroke recovery, including spatial neglect, of the Family-Clinician Collaboration program, where a family member of a stroke survivor actively interacts with clinical staff members providing inpatient rehabilitation services to the stroke survivor.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

September 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2023

Enrollment Period

7.3 years

First QC Date

January 2, 2018

Last Update Submit

November 20, 2025

Conditions

StrokeSpatial Neglect

Outcome Measures

Primary Outcomes (2)

  • Spatial neglect assessment battery

    Searching visual targets, writing, reading, drawing, and other tasks that require exploration of the person's surroundings. The primary outcome measure is the change between before and immediately after intervention.

    Before and immediately after intervention

  • Family caregiver wellness

    Self-reported questionnaires regarding emotional status, caregiving stress and burden. The primary outcome measure is the change between before and immediately after intervention.

    Before and immediately after intervention

Secondary Outcomes (3)

  • FCC feedback

    Immediately after intervention

  • Spatial neglect assessment battery

    4 weeks after intervention

  • Family caregiver wellness

    4 weeks after intervention

Study Arms (1)

Family-Clinician Collaboration

EXPERIMENTAL

Participants are dyads of a stroke survivor and their family member. Family members will work closely with the Clinician to understand the status and goals of the stroke survivor, and family members will integrate Family-Mediated Treatment Procedures into their time spent with the stroke survivor at home.

Behavioral: Family-Clinician Collaboration Program

Interventions

Family-Clinician Collaboration ProgramBEHAVIORAL

Family-mediated treatment activities and collaboration between clinician and family members

Also known as: FCC
Family-Clinician Collaboration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral right brain stroke
  • Functionally independent before stroke
  • Presence of spatial neglect (moderate to severe, will be confirmed during the screening session)
  • Ability to follow instructions and understand verbal or written English
  • Currently living with a family member who will be enrolled into the study as well

You may not qualify if:

  • History of progressive neurological disorder
  • History of a significant psychiatric disorder
  • Living outside of 50-mile radius of Kessler Foundation (West Orange, NJ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

  • Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

    PMID: 34196963DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Peii Chen, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 18, 2018

Study Start

September 30, 2017

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

November 25, 2025

Record last verified: 2023-11

Locations

US(1)