Dosing and Deployment Trial: A Home-based Optokinetic Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-110
SponsorDuke University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

first and unilateral right brain damage stroke, confirmed by medical records,

time post stroke >6 months,

moderate to severe SN, classified using the Catherine Bergego Scale (CBS) via the Kessler Foundation Neglect Assessment Process (KF-NAP),

over age of 60 years, and

Disqualifiers

history of multiple strokes or neurological incidents (e.g., traumatic brain injury, seizures, or brain tumor),

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,

cognitive impairment as defined by the Blind-MoCA,

dependent in mobility- walking or wheelchair via medial chart,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optokinetic stimulation

    Behavioral

    Visual scanning (repeated eye movements) from one side of the computer to the neglected side of space. The target is 30 to 70 dots, randomly displayed (of all colors, size: 2- 4 cm) on a dark background on a computer screen.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Treatment Group 1Active comparator 1 intervention
Group B: Treatment Group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Mobility Assessment Course

Evaluates a person's mobility, using visual search multitask, to assess neglect, and its relation with existing neglect tasks. The change in score from pre- to post-treatment is the primary outcome measure of the study. For this assessment, the focus on side-to side spatial imbalance (the total score is the difference between targets found on the right versus the left side). There are 40 targets (20 on each side). Lower total score indicates a poorer performance (0-40). The mean control asymmetry= 0.75 (SD=0.81), and if the asymmetry score is greater or equal to 2.78, neglect is present.

Time frame
20 minutes

Secondary outcomes

1

Health-ITUES

A 20-item questionnaire that evaluates the impact, perceived usefulness, perceived ease of use about a specific technology. The change in score from pre- to post-treatment is a secondary outcome measure of the study. The score is calculated as the mean of all items with each item weighted equally. The higher the score, the more usable the person feels the technology is. Range of possible scores is 1 to 5.

Time frame
10 minutes
2

Stroke Assessment of Fall Risk

A tool which includes items related to stroke-specific neurologic deficits to determine the ability to predict falls. The change in score from pre- to post-treatment is a secondary outcome measure of the study. If the total score has 0 yes responses- there is low fall risk. If the total score = 1 yes response, then there is a level 1 fall risk. And if the total score =2 or more yes responses, or any yes response to item 3 (nursing judgment) then this is a Level 2 fall risk (highest amount).

Time frame
10 minutes
3

Caregiver Burden Scale

A 22-item scale to determine burden that is experienced by care partners. The change in score from pre- to post-treatment is a secondary outcome measure of the study. There are multiple categories in this scale. Items 1-8 gains insight into general strain, 9-11 captures information on isolation, and 12-16 captures information on disappointment, and 17-19 on emotional involvement, and 20-22 on environmental burden. The higher the score the more burden the caregiver has (range from 1 (not at all) to 88 (often)).

Time frame
10 minutes

Other outcomes

1

The Oxford Cognitive Screen

Designed for stroke survivors to bypass common post-stroke barriers such as aphasia and spatial neglect. It is evaluated across 14 distinct subtests that span 5 cognitive domains: attention, memory, language, number processing, and praxis. Each subtest is scored on its own range and compared against specific clinical cutoff thresholds. Rather than a single number test, it evaluates multiple distinct tasks, each with its own minimum and maximum values. For the majority of the subtests, a higher score denotes better cognitive functioning. The numbers here indicate the range (0-max). Picture Naming (0-4), Sentence reading (0-15), Semantics (0- 3), Orientation (0-4), Visual field assessment (0-4), Number writing (0-3), Calculations (0-4), Visual Spatial Neglect (Broken Hearts Test) (0-50 left gap, 0-50 right gap, 0-50 total correct), Meaningless Gesture Imitation (0-12), Verbal memory- free recall (0-4), Verbal memory -recognition (0-4), Episodic (0-4), Executive (0-13).

Time frame
15 minutes
2

Catherine Bergego Scale via the Kessler Foundation Neglect Assessment Process

10 real-life items that are assessed through direct observation following the Kessler Foundation Neglect Assessment Process (KF-NAP). The 10 items are: gaze orientation (\*which is IGD), limb awareness, auditory attention, personal belongings, dressing, grooming, navigation, collisions, meals, and cleaning after meals. Each item is scored from 0 (no neglect) to 3 (severe neglect). The final scores from 0-30 and indicates the overall severity of spatial neglect as one single construct.

Time frame
45 minutes
3

Aphasia Rapid Test

Screens for communication deficits that would impact ability to follow instructions with higher score indicating more severe aphasia (0/26), 0= no aphasia and 26= the most aphasia possible.

Time frame
3 minutes

Locations

This trial has no locations.

Sponsors and contacts

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