Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke

NCT ID: NCT03402906

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2025-03-31

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.

Detailed Description

Spatial neglect (SN) frequently occurs in patients who have had a stroke. The problems caused by SN result in patients failing to attend to the space contralateral to the side of the stroke. This failure to attend to half of the patient's field may result in problems with perception, memory, action planning and navigation. These deficits hurt both the patients and their caregivers, and make it difficult for them to resume daily activities as they were before the stroke. More than half of the patients who had SN at admission still had it when discharged from an inpatient rehabilitation facility.

This study examines a new behavioral treatment, where the clinician and the caregiver work together to provide better treatment. The family members will engage in frequent meetings with clinicians, set goals, learn about SN and coping strategies and have the patient to perform easy, safe treatment exercises. The study will compare this Family-Clinician Collaboration with the inpatient treatment control. This study will compare the groups in measures of spatial neglect and independence in the patients and measures of caretaker burden and mental health in family members. Participants will also report on their overall opinions of the new treatment condition.

Conditions

Stroke; Spatial Neglect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family-Clinician Collaboration

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.

Group Type: EXPERIMENTAL

Family-Clinician Collaboration Program

Intervention Type: BEHAVIORAL

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

Interventions

Family-Clinician Collaboration Program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

FCC

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Peii Chen

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peii Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34196963 (View on PubMed)

Other Identifiers

E-991-17

Identifier Type: -

Identifier Source: org_study_id