Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-27 @ 10:25 AM
Study NCT ID:
NCT06527261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Sponsor:
University of Melbourne
Organization:
Study Overview
Official Title:
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
eCARE4Stroke
Brief Summary:
This is a prospective cohort study to determine the feasibility of accurate, complete, and timely real-time electronic capturing of upper limb motor intervention sessions during usual care. In clinical trials accurate reporting of usual care for people with stroke is scarce, thus understanding the control group compared to the experimental group is poor. The unit of measure in this study is therapy sessions, where a clinician is providing usual care to a patient.
The observed sessions will occur in two Austin Health settings: Acute at Austin HospitalÍž subacute, across Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital. For each session, patient characteristics, dose and content of upper limb interventions will be electronically captured in REDCap. Additionally, the sessions will be video recorded to allow a second rater to assess feasibility. The secondary aim is to determine if there is an association between the dose and content of upper limb intervention sessions and the contextual factors of stroke patients. Two participant groups will be recruited: Stroke patients and Clinicians (Occupational Therapists and Allied Health Assistants).
The observed sessions will occur in two Austin Health settings: Acute at Austin HospitalÍž subacute, across Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital. For each session, patient characteristics, dose and content of upper limb interventions will be electronically captured in REDCap. Additionally, the sessions will be video recorded to allow a second rater to assess feasibility. The secondary aim is to determine if there is an association between the dose and content of upper limb intervention sessions and the contextual factors of stroke patients. Two participant groups will be recruited: Stroke patients and Clinicians (Occupational Therapists and Allied Health Assistants).
Detailed Description:
This is a prospective observational cohort study to determine the feasibility of accurate, complete, and timely real-time electronic capturing of upper limb motor intervention sessions during usual care.
In clinical trials accurate reporting of usual care for people with stroke is scarce, thus understanding the control group compared to the experimental group is poor.
The unit of measure is the therapy sessions, where a clinician is providing usual care to a patient. The observed sessions will occur across two Austin Health settings. Setting A: Acute at Austin Hospital, and Setting B: Subacute at Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital.
For each session, patient characteristics, the multiple dimensions of dose, and the content of usual care motor upper limb interventions will be electronically captured in REDCap. The observed sessions will be video recorded and a second rater will review the session for dose data accuracy. Secondary to determining feasibility, the dose and content data from observed sessions will be analysed to investigate the association of context factors such as setting and upper limb impairment severity.
As such, this study aims to answer the following research questions:
* Is it feasible for clinicians to electronically capture accurate, complete, and timely upper limb motor intervention session dose during usual care of stroke patients?
* Is there an association between dose and content of upper limb intervention sessions and the contextual factors of stroke patients?
In clinical trials accurate reporting of usual care for people with stroke is scarce, thus understanding the control group compared to the experimental group is poor.
The unit of measure is the therapy sessions, where a clinician is providing usual care to a patient. The observed sessions will occur across two Austin Health settings. Setting A: Acute at Austin Hospital, and Setting B: Subacute at Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital.
For each session, patient characteristics, the multiple dimensions of dose, and the content of usual care motor upper limb interventions will be electronically captured in REDCap. The observed sessions will be video recorded and a second rater will review the session for dose data accuracy. Secondary to determining feasibility, the dose and content data from observed sessions will be analysed to investigate the association of context factors such as setting and upper limb impairment severity.
As such, this study aims to answer the following research questions:
* Is it feasible for clinicians to electronically capture accurate, complete, and timely upper limb motor intervention session dose during usual care of stroke patients?
* Is there an association between dose and content of upper limb intervention sessions and the contextual factors of stroke patients?
Study Oversight
Has Oversight DMC:
False
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?: