The Enriched Environment as an Integrated Tool in the Ward Setting

University of Padova50 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Stroke, Acute

Interventions

Enriched environmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Teaching Hospital, University of Padova

Padova, Italy

RECRUITING

Outcomes

Primary Outcomes

Stroke Impact Scale

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.

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 Outcomes

Functional Independence Measure (FIM) scale

Functional Independence Measure (FIM) scale is used to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126.

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

The Functional Assessment Test for Upper Limb (FAST-UL) is a clinical scale based on observational movement analysis of UL impairment in stroke survivors, composed of 5 items measured through a 4-level ordinal scale.The items identified by the panel of experts are Hand to Mouth (HtM), RtT, PS, GaR, and PaR.

Time frame: T0: baseline (enrollment), T1: immediately after intervention (discharge)

Functional Ambulatory Category (FAC)

The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Scoring range from 0: nonfunctional ambulator to 5: Ambulator, independent.

Central Contacts

Francesca Venturini

CONTACT

049 8212341 ce.sperimentazione@aopd.veneto.it

Data from ClinicalTrials.gov

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