Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527261
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Sponsor:
None
Organization:
None
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:
No
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 Hospital 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 Hospital 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None