The Enriched Environment as an Integrated Tool in the Ward Setting (ENVIRONMENT)

U

University of Padova

Status

Not yet enrolling

Conditions

Stroke
Stroke, Acute

Treatments

Other: Enriched environment

Study type

Interventional

Funder types

Other

Identifiers

NCT06233682
PROTOCOL_ENVIRONMENT

Details and patient eligibility

About

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.

Full 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 70 people with stroke (35 for experimental and control group). After providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up visit) 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Enriched environment group
Experimental group
Description:
35 people with stroke recruited from the in-patient ward of the Neurology Clinic, meeting the inclusion criteria.
Treatment:
Other: Enriched environment
No intervention
No Intervention group
Description:
35 people with stroke recruited from the in-patient ward of the Neurology Clinic, meeting the inclusion criteria.

Trial contacts and locations

0

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Central trial contact

Francesca Venturini

Data sourced from clinicaltrials.gov

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