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The Enriched Environment as an Integrated Tool in the Ward Setting

NCT ID: NCT06233682

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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

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Stroke Stroke, Acute

Keywords

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enriched environment in-patients setting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enriched environment group

25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria.

Group Type EXPERIMENTAL

Enriched environment

Intervention Type 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.

No intervention

25 people with stroke recruited from the acute in-patient ward of the Neurology Clinic, meeting the inclusion criteria.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Del Felice

Associate Professor of Physical and Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Del Felice, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

Locations

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Teaching Hospital, University of Padova

Padua, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesca Venturini

Role: CONTACT

Phone: 049 8212341

Email: [email protected]

Facility Contacts

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Alessandra Del Felice, MD, PhD

Role: primary

Other Identifiers

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PROTOCOL_ENVIRONMENT

Identifier Type: -

Identifier Source: org_study_id