The Enriched Environment as an Integrated Tool in the Ward Setting

NCT06233682 | Recruiting

• 1 other identifier: PROTOCOL_ENVIRONMENT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke, Acute

Keywords

enriched environment; in-patients setting

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• 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 Assessment Test for Upper Limb

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

• 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)

• Dynamic Gait Index (DGI) if FAC > 3

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

• Oxford Cognitive Screening (OCS)

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

Study Arms (2)

Enriched environment group

EXPERIMENTAL

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

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.

Interventions

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.

Enriched environment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
• Participant consent to participate in the study;
• Mecial stabilisation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Teaching Hospital, University of Padova

Padua, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alessandra Del Felice, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Venturini

CONTACT

049 8212341; ce.sperimentazione@aopd.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical and Rehabilitation Medicine

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 31, 2024
• Study Start: December 3, 2024
• Primary Completion: June 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Upon study completion
• Access Criteria: Upon direct request of researchers providing any official reaserch identification (ORCID, Reaserch ID, etc)

Locations

IT (1)