Clinical trial NCT06233682: The Enriched Environment as an Integrated Tool in the Ward Setting
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke, Acute
Keywords: enriched environment
in-patients setting
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Longitudinal interventional study in which participants are not randomised, as the experimental design alternates sequentially between the control and experimental groups, with no possibility of interaction between the two groups.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 outcomes:
measure: Stroke Impact Scale
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
Secondary outcomes:
measure: Functional Independence Measure (FIM) scale
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
measure: Functional Assessment Test for Upper Limb
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge)
measure: Functional Ambulatory Category (FAC)
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
measure: Dynamic Gait Index (DGI) if FAC > 3
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge)
measure: Oxford Cognitive Screening (OCS)
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge)
measure: Typical values of Physical Activity Level (PAL)
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
measure: Motor Activity Log
timeFrame: T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
measure: Ad hoc behavioral mapping checklist
timeFrame: T0: baseline (enrollment), T1: immediately after intervention (discharge)
measure: Ad hoc questionnaire for health care workers
timeFrame: T1: post intervention
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Teaching Hospital, University of Padova
Study officials:
affiliation: University of Padova
name: Alessandra Del Felice, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: