An observational study in Spatial Neglect, sponsored by Istituto Auxologico Italiano. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Istituto Auxologico Italiano · Observational
This multi-center project aims to quantify the socio-medical costs associated with Unilateral Spatial Neglect (USN) resulting from acquired brain injury (stroke) and to measure the effects of USN rehabilitation on functional autonomy, quality of life and psychological well-being of patients affected by this syndrome, considering the repercussions on a psychological level and on the quality of life of caregivers.
To this end, the experimenters will administer to right brain-injured patients - with (Experimental Group) or without (Control Group) USN - who undertook a rehabilitation process, a series of questionnaires: Activities of daily living (ADL), Barthel Index; Instrumental activities of daily living scale (I-ADL:), the Health Related Quality of Life questionnaire (EQ-5D-5L), the Geriatric Depression Scale (GDS), and the State-Trait Anxiety Inventory (STAI-Y). The aforementioned tests will be administered before the start of the rehabilitation (baseline) and after one month, 3, 6 and 12 months after the end of the rehabilitation. The impact of USN and its treatment on the psycho-physical well-being of the caregiver will be measured through the Caregiver Burden Inventory questionnaire, which will be administered with the same timing (baseline, 1-3-6-12 months after rehabilitation). The costs of USN will be surveyed through an ad-hoc questionnaire, which includes a version intended for patients and one for caregivers, in order to identify the resources consumed due to the disease and the expenses taken during the observation period, to be estimated subsequently in monetary terms (€).
92 studies on the registry are indexed under Perceptual Disorders; 23 are open to participants now.
This study's planned enrollment of 168 is above the median of 80 across 19 observational studies indexed under Perceptual Disorders.
Browse Perceptual Disorders studies →Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Stroke patients with and without USN and their caregivers
For stroke patients with USN:
Exclusion Criteria:
Behavioral: Functional measures and public health outcomes
Behavioral: Functional measures and public health outcomes
Questionnaires: * Activities of daily living - ADL * Barthel Index * Instrumental activities of daily living- IADL * Health Related Quality of Life - EQ-5D-5L * Geriatric Depression Scale (GDS) * State-Trait Anxiety Inventory - STAI-Y) * Caregiver Burden Inventory questionnaire (CBI)
Change in the Activities of Daily Living scale (ADL)
To evaluate the degree of patients' functional independence in everyday life
Time frame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
Change in the Instrumental Activities of Daily Living scale (I-ADL)
To evaluate the degree of patients' functional independence instrumental activities, including, e.g., cleaning, cooking, and managing finances.
Time frame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
Change in the Health-Related Quality of Life (EQ-5D-5L)
A brief scale assessing patient's health-related quality of life
Time frame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
Change in the Geriatric Depression Scale (GDS)
A scale assessing patients' depressive symptoms
Time frame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
Change in the State-Trait Anxiety Inventory (STAI-Y)
A scale assessing patients' anxiety symptoms
Time frame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
Change in the Caregiver Burden Inventory questionnaire (CBI)
A scale that assess caregivers' physical and psychological burden
Time frame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
Financial impact of USN
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
Time frame: 1 month after the end of the treatment
Financial impact of USN
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
Time frame: 3 months after the end of the treatment
Financial impact of USN
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
Time frame: 6 months after the end of the treatment
Financial impact of USN
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
Time frame: 12 months after the end of the treatment
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Istituto Auxologico Italiano