Using an enriched environment to help stroke recovery in a hospital ward
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
This study is testing whether creating a more engaging and supportive environment in the hospital can help stroke patients recover better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Padova Academic / other |
| Locations | 1 site (Padova) |
| Trial ID | NCT06233682 on ClinicalTrials.gov |
What this trial studies
This longitudinal interventional study aims to integrate an enriched environment (EE) within the Neurology Clinic ward at the University of Padua to assess its effectiveness on psychological well-being, functional recovery, activity level, and quality of life in stroke patients. The EE will include materials and aids designed to promote physical, cognitive, and social activities among inpatients. A total of 50 participants will be recruited and pseudo-randomized into experimental and control groups, with evaluations conducted at admission, discharge, and during follow-up interviews at 4 weeks and 6 months. The study will utilize the Stroke Impact Scale to measure multidimensional recovery and assess various secondary outcomes related to motor, cognitive, and communication functions.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced an ischemic or hemorrhagic stroke and are medically stable.
Not a fit: Patients who are uncooperative, have severe cognitive impairments, or lack the ability to maintain a safe posture will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and quality of life for stroke patients during their hospital stay.
How similar studies have performed: While the integration of enriched environments in clinical settings is a growing area of interest, this specific approach is relatively novel and has not been extensively tested in stroke recovery contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Padova
- Teaching Hospital, University of Padova — Padova, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandra Del Felice, MD, PhD — University of Padova
- Study coordinator: Francesca Venturini
- Email: ce.sperimentazione@aopd.veneto.it
- Phone: 049 8212341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.