Austin Health
Melbourne, Victoria, 3084, Australia
NCT Number: NCT06527261
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).
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Melbourne, Victoria, 3084, Australia
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Group 1: Stroke patients
Inclusion criteria
Exclusion criteria
Group 2: Clinicians
Inclusion criteria
Exclusion criteria
During usual care sessions, clinicians will real-time capture information about the intervention session into REDCap. This information is related to the multi-dimensional dose articulation framework e.g., content of the session and difficulty of the task, session length, episode length, and number of repetitions.
The usual care motor upper limb intervention the patient receives is determined by the clinician providing the care. The therapy may include but is not limited to strength training, task specific retraining, constraint induced movement therapy, mirror box, and electrical stimulation.
Time frame: Each feasibility session will take up to one hour.
A single binary composite primary outcome, where feasibility is defined by 90% of sessions achieving ALL of:
Contact information is provided by the study sponsor or research team.
Kate Hayward, PhD
CONTACT
Sarah P Newton, BOccTh(Hons)
CONTACT
University of Melbourne
Other
Acronym: eCARE4Stroke
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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