StrokeENVIRONMENTNCT06233682
The Enriched Environment as an Integrated Tool in the Ward Setting
A study testing Enriched environment in people with Stroke and Stroke, Acute, run by University of Padova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Acute
- What is being tested?
- Enriched environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
- Participant consent to participate in the study;
- Mecial stabilisation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Teaching Hospital, University of Padova
Padova, 35128
Alessandra Del Felice, MD, PhD, 0039(0)498213600, alessandra.delfelice@unipd.it
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Stroke, Acute
- Being tested
- Enriched environment
- Keywords
- enriched environment, in-patients setting
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Enriched environment group | Experimental | 25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria. Receives: Other: Enriched environment |
| No intervention | No intervention | 25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T0: baseline (enrollment), T1: immediately after intervention (discharge)
Ad hoc questionnaire for health care workers
Assessing impact on ward organisation.
Measured: T1: post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start3 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Del Felice, University of Padova
- Investigators
- Alessandra Del Felice, MD, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233682
- Sponsor's protocol ID
- PROTOCOL_ENVIRONMENT
- Acronym
- ENVIRONMENT
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data sheet
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06233682
- Acronym / sponsor ID
- ENVIRONMENT / PROTOCOL_ENVIRONMENT
- Conditions
- Stroke, Stroke, Acute
- Keywords
- enriched environment, in-patients setting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enriched environment group | Experimental | Other: Enriched environment25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria. |
| No intervention | No intervention | –25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
- Participant consent to participate in the study;
- Mecial stabilisation.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched environmentIn 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. | Other | Enriched environment group |
Primary outcome
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)
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes. Anonymized data sheet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandra Del Felice, MD, PhD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched environment in people with Stroke and Stroke, Acute, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Venturini (049 8212341, ce.sperimentazione@aopd.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.