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NCT07519317
Dosing and Deployment Trial: A Home-based Optokinetic Treatment
Conditions: Spatial Neglect
Sex: All
Ages: 60 Years – 110 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 90
Sponsor: Duke University
Summary
Several interventions exist for remediation of spatial neglect, but they have mixed evidence. Optokinetic stimulation is a bottom-up intervention; in other words, it is a stimulus-driven process, with Level A (strongest) evidence, and is recommended in clinical practice guidelines such as the American Heart Association's stroke guidelines. The studies currently published all use varing doses (number of sessions a week), did not assess the impact on mobility and risk of falls, and have not been implemented in the home setting. It is imperative to understand how to successfully implement this intervention at home, and learn how it will impact mobility in order to better support a large population of individuals living with chronic spatial neglect and who face barriers to accessing care because they require caregiver support to leave the home. This will be done using both qualitative and quantitative methods.
Eligibility Criteria
Inclusion Criteria for stroke group:
1. first and unilateral right brain damage stroke, confirmed by medical records,
2. time post stroke \>6 months,
3. moderate to severe SN, classified using the Catherine Bergego Scale (CBS) via the Kessler Foundation Neglect Assessment Process (KF-NAP),
4. over age of 60 years, and
5. IGD noted either on the KF-NAP or neuroimaging from medical records.
Exclusion Criteria for stroke group:
1. history of multiple strokes or neurological incidents (e.g., traumatic brain injury, seizures, or brain tumor),
2. unable to communicate through spoken English, screened using the Aphasia Rapid Test (ART), as instructions for treatment and assessment tasks will be provided verbally in English,
3. cognitive impairment as defined by the Blind-MoCA,
4. dependent in mobility- walking or wheelchair via medial chart,
5. legally blind per medical chart,
6. home located out of a 50-mile radius from Duke University, making it too costly for the frequent home visits, and
7. no IGD present.
Inclusion Criteria for caregiver group:
1. a current care partner (defined as someone providing care and assistance) of a stroke survivor living with SN,
2. English speaker,
3. the stroke survivor they are caring for has been enrolled into the study.
Exclusion Criteria for caregiver group:
1. not a care partner currently,
2. can't speak English,
3. the stroke survivor didn't consent
Source: ClinicalTrials.gov (NCT07519317). StuddyBuddy aggregates publicly available trial information.