Ireland
--:--IST
Recruiting Not applicable

The Enriched Environment as an Integrated Tool in the Ward Setting

NCT06233682 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-12-03
Last updated
2024-12-06

Condition(s) studied

StrokeStroke, Acute

Investigational drug(s) / intervention(s)

Enriched environment

Enriched environment: In the experimental group (enriched environment), assistants will supervise participants sponatneoulsy engaging in activities, including listening to music, drawing, playing cards or board games, exercising the affected upper limb with constructions or puzzles, etc., in the living room and personal rooms. Posters and clocks will also aid in orientation and improve the physical environment.

Study summary

The goal of this longitudinal interventional study is to integrate the enriched environment (EE) in the context of the Neurology Clinic ward of the General Hospital - University of Padua, by verifying its effectiveness and impact on psychological well-being, functional recovery, activity level, and quality of life in people with stroke.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment; * Participant consent to participate in the study; * Mecial stabilisation. Exclusion Criteria: * Uncooperative participant, as assessed by theMontreal Cognitive Assessment scale \< 15 * medically not stabtability and/or reduced level of consciousness and/or psychomotor agitation; * Lack of trunk control (score \<12 in item 3 of the Trunk Control Test: balance in sitting position) such that it is impossible to maintain a sitting position or a safe posture in a wheelchair; * Speech evaluation confirming comprehension aphasia hampering understanding of informed consent.

Primary outcome measure(s)

  • Stroke Impact Scale — T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
    The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. SIS is a 59-item measure. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores range from 0-100.

Trial sites (1)

FacilityCityRegionStatus
Teaching Hospital, University of Padova Padova Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06233682 on ClinicalTrials.gov ↗ ← All trials in Italy