NCT06233682

The Enriched Environment as an Integrated Tool in the Ward Setting

The Enriched Environment as an Integrated Tool in the Ward Setting for Improving Functional Outcome in People With Acute Stroke: a Study Within the Neurological Clinic Unit

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The EE will be integrated within the shared areas of the Neurology ward and in inpatient rooms, providing materials and aids to encourage physical, cognitive and social activity. The study will recruit for 9 months plus 6 months of follow-up. It will recruited a total of 50 people with stroke (25 for experimental and control group). After providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up phone interview) and at 6 months (telephone interview). Participants will be psuedo randomized, as the ward will be environmentally enriched during consecutive alternating time frames. The instrument used to measure the multidimensional recovery will be the Stroke Impact Scale. Specific secondary outcomes will assessed the recovery in motor, cognitive and communication function, the impact on physical activity, mood, the type of activity of participants exposed to EE and the impact on the ward organization.

Conditions

• Stroke
• Stroke, Acute

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-12-03
• Primary completion: 2025-06-30
• Completion: 2025-11-30
• First posted: 2024-01-31
• Last updated: 2024-12-06

Locations

1 site across 1 country: Italy