Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-11-27
Brief Title:
The Enriched Environment as an Integrated Tool in the Ward Setting
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENVIRONMENT
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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None