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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched environment group | Experimental | 25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria. |
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| No intervention | No Intervention | 25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched environment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Venturini | Contact | 049 8212341 | ce.sperimentazione@aopd.veneto.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandra Del Felice, MD, PhD | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching Hospital, University of Padova | Recruiting | Padova | 35128 | Italy |
Anonymized data sheet
Upon study completion
Upon direct request of researchers providing any official reaserch identification (ORCID, Reaserch ID, etc)
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| 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. | 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. | 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 | 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. | T0: baseline (enrollment), T1: immediately after intervention (discharge) |
| Oxford Cognitive Screening (OCS) | 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. | T0: baseline (enrollment), T1: immediately after intervention (discharge) |
| Typical values of Physical Activity Level (PAL) | 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. | 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) | 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. | 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 | 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. | T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview) |
| Ad hoc behavioral mapping checklist | Tool created to quantify and study the type of activity (physical, cognitive, social) carried out by participants. | T0: baseline (enrollment), T1: immediately after intervention (discharge) |
| Ad hoc questionnaire for health care workers | Assessing impact on ward organisation. | T1: post intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |