The Enriched Environment as an Integrated Tool in the Ward Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enriched environment.
- Who it may be relevant to
- Registry conditions: Stroke, Stroke, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Stroke Impact Scale [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
Secondary outcome measures (10)
- Functional Independence Measure (FIM) scale [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Functional Assessment Test for Upper Limb [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Functional Ambulatory Category (FAC) [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Dynamic Gait Index (DGI) if FAC > 3 [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Oxford Cognitive Screening (OCS) [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Typical values of Physical Activity Level (PAL) [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Motor Activity Log [Time frame: T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Ad hoc behavioral mapping checklist [Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Ad hoc questionnaire for health care workers [Time frame: T1: post intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Teaching Hospital, University of Padova — Padova
Identifiers
NCT: NCT06233682 · PROTOCOL_ENVIRONMENT