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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.
Stroke is a leading cause of disability among adults in the United States (US) and increases the risk of falls. One factor associated with excess fall risk after stroke is spatial neglect, which occurs in 54% of right brain damaged stroke survivors. Spatial neglect is caused by damaged neural networks critical for spatial attention. A hallmark symptom of spatial neglect is ipsilesional gaze deviation (IGD) , which is a sustained horizontal gaze preference toward the affected brain hemisphere. Since IGD is a major predictor of poor recovery-adversely affecting daily activities and functional mobility, and extending hospital stays because of falls-intervention is necessary. And because of the challenges of the traditional rehabilitation paradigm (short length of stay), there is a significant need for an intervention, accessible to individuals living at home with SN, that will improve mobility and risk of falls.
Optokinetic stimulation is a treatment shown to induce brain neural plasticity and improve spatial exploration, in turn reduce spatial neglect symptoms, including IGD, experienced in daily life. Optokinetic stimulation requires the participant to follow one step command: "follow the targets with your eyes". The target is a small dot that moves across the computer screen. The literature shows variation in implementation because users (mostly therapists) were required to create their own optokinetic stimulation, until just recently when Eyemove was developed. Eyemove is computer-based intervention developed to standardize the way optokinetic stimulation is administered, via an inexpensive, commercially available software program.
Via a randomized clinical trial, the researchers plan to focus on dose and feasibility in the home setting to answer the specific aims.
The study will randomize stroke participants who meet all inclusion and exclusion criteria into two intervention dose groups. Group 1 will complete 3-sessions of Eyemove, and Group 2 will complete 5-sessions of Eyemove, all within 7-9 days. Outcomes will be measured at baseline, before and after the treated period. Screening and pre-treatment assessments will take approximately 2 hours, and the post assessments will take approximately 1 hour. The post-treatment assessments will be conducted 14 days after the pre-treatment assessments.
In the interest of feasibility and limiting unnecessary burden on participants, the study team will then conduct semi-structured interviews pre-treatment with at least the first 8 stroke participants who are randomized into each group. The study team will interview them again post-treatment and will also interview care partners of stroke survivors at time of screening and pre-treatment assessment, to participate in semi-structured interviews and two assessments. The researchers will also plan to conduct these with the first 8 care partners from each group, which will be determined after the stroke survivor is randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Active Comparator | 3 50-minute sessions of optokinetic stimulation over 7-9 days |
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| Treatment Group 2 | Active Comparator | 5 50-minute sessions of optokinetic stimulation over 7-9 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria for stroke group:
Exclusion Criteria for stroke group:
Inclusion Criteria for caregiver group:
Exclusion Criteria for caregiver group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Hreha, EdD, OTR/L | Contact | 919-660-7596 | kimberly.hreha@duke.edu | |
| Cassandra (CJ) Rhodes, MS, ATC | Contact | 919-660-9301 | cassandra.rhodes@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kimberly Hreha, EdD, OTR/L | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Randomized clinical trial with both qualitative and quantitative methods.
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| 10 minutes |
| 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). | 10 minutes |
| 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)). | 10 minutes |
| 15 minutes |
| 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. | 45 minutes |
| 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. | 3 minutes |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |