The Enriched Environment as an Integrated Tool in the Ward Setting
- Conditions
- StrokeStroke, Acute
- Interventions
- Other: Enriched environment
- Registration Number
- NCT06233682
- Lead Sponsor
- University of Padova
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
- Participant consent to participate in the study;
- Mecial stabilisation.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Enriched environment group Enriched environment 35 people with stroke recruited from the in-patient ward of the Neurology Clinic, meeting the inclusion criteria.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Functional Independence Measure (FIM) scale T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview) 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.
Functional Assessment Test for Upper Limb T0: baseline (enrollment), T1: immediately after intervention (discharge) 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.
Functional Ambulatory Category (FAC) T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview) 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.
Dynamic Gait Index (DGI) if FAC > 3 T0: baseline (enrollment), T1: immediately after intervention (discharge) The Dynamic Gait Index (DGI) is a clinical tool used to assess gait, balance and fall risk. It evaluates not only the usual steady-state walking, but also walking during more challenging tasks. Scores are based on a 4-point scale. Highest possible score is 24 points.
Oxford Cognitive Screening (OCS) T0: baseline (enrollment), T1: immediately after intervention (discharge) The Oxford Cognitive Screen (OCS) is a first-line, stroke-specific and domain-specific cognitive screening tool which can be delivered at the bedside in acute stroke.
Typical values of Physical Activity Level (PAL) T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview) The physical activity level (PAL) is a way to express a person's daily physical activity as a number, and is used to estimate a person's total energy expenditure. Ranges: Extremely inactive PAL \<1.40 - Extremely active PAL \>2.40.
Hospital Anxiety and Depression Scale (HADS) 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) is used to determine the levels of anxiety and depression. The HADS is a fourteen item scale. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Motor Activity Log T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview) Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during daily functional tasks.
Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Items scored on a 6-point ordinal scale.Ad hoc behavioral mapping checklist T0: baseline (enrollment), T1: immediately after intervention (discharge) Tool created to quantify and study the type of activity (physical, cognitive, social) carried out by participants.
Ad hoc questionnaire for health care workers T1: post intervention Assessing impact on ward organisation.
Trial Locations
- Locations (1)
Teaching Hospital, University of Padova
🇮🇹Padova, Italy