StrokeNCT03402906
Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke
A study testing Family-Clinician Collaboration Program in people with Stroke and Spatial Neglect, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spatial Neglect
- What is being tested?
- Family-Clinician Collaboration Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of progressive neurological disorder
- History of a significant psychiatric disorder
- Living outside of 50-mile radius of Kessler Foundation (West Orange, NJ)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Family-Clinician Collaboration Program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Clinician Collaboration ProgramBehavioural
Also called FCC
Family-mediated treatment activities and collaboration between clinician and family members
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family-Clinician Collaboration Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and immediately after intervention
Secondary outcomes (3)
FCC feedback
Semi-structured interview on the experience of the study participation
Measured: Immediately after intervention
Spatial neglect assessment battery
Searching visual targets, writing, reading, drawing, and other tasks that require exploration of the person's surroundings.
The outcome measure is the change between immediately after intervention and 4-week follow-up.
Measured: 4 weeks after intervention
Family caregiver wellness
Self-reported questionnaires regarding emotional status, caregiving stress and burden.
The outcome measure is the change between immediately after intervention and 4-week follow-up.
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start30 Sep 2017
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peii Chen, Kessler Foundation
- Investigators
- Peii Chen, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402906
- Sponsor's protocol ID
- E-991-17
- Status last verified
- Nov 2023
- First submitted
- 2 Jan 2018
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke
- ClinicalTrials.gov ID
- NCT03402906
- Acronym / sponsor ID
- E-991-17
- Conditions
- Stroke, Spatial Neglect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family-Clinician Collaboration | Experimental | Behavioral: Family-Clinician Collaboration ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- History of progressive neurological disorder
- History of a significant psychiatric disorder
- Living outside of 50-mile radius of Kessler Foundation (West Orange, NJ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-Clinician Collaboration ProgramAlso: FCCFamily-mediated treatment activities and collaboration between clinician and family members | Behavioural | Family-Clinician Collaboration |
Primary outcome
Spatial neglect assessment battery
Time frame: Before and immediately after intervention
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.
Family caregiver wellness
Time frame: Before and immediately after intervention
Self-reported questionnaires regarding emotional status, caregiving stress and burden. The primary outcome measure is the change between before and immediately after intervention.
3 secondary outcomes
FCC feedback
Time frame: Immediately after intervention
Spatial neglect assessment battery
Time frame: 4 weeks after intervention
Family caregiver wellness
Time frame: 4 weeks after intervention
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 34196963Longley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peii Chen, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Clinician Collaboration Program in people with Stroke and Spatial Neglect, run by Kessler Foundation 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 25 Nov 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?
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial neglect assessment battery (time frame: Before and immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402906, which also lists 1 linked publication.
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 25 Nov 2025.