StrokeeCARE4StrokeNCT06527261
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
An observational study of Stroke, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Real-time electronic data input into REDCap
- How many people
- 146 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2024to Dec 2026
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group 1: Stroke patients These participants will be selected from inpatients within the tertiary health service of Austin Health in Melbourne, Victoria, Australia. They may be located at the acute setting: Austin hospital, Or subacute setting: Heidelberg repatriation hospital or Royal Talbot rehabilitation Centre. Group 2: Clinicians Clinicians will be invited to participate if they are an Occupational Therapist or allied health assistant working at Austin health with the stroke patient population.
Who may be able to join
- Adults (≥18 years) with a new, first or consecutive stroke, confirmed on CT or MRI.
- Motor upper limb impairment defined by a Shoulder Abduction and Finger Extension (SAFE) score of 0 through 9.
- Able to consent for themselves.
- Likely to receive at least one upper limb intervention session as determined by the treating clinical team.
- Occupational therapist or allied health assistant working with the stroke population in an acute or subacute settings within Austin Health.
- At least four months of clinical experience
Who cannot join
- Existing co-morbidities that limit upper limb function and usual care treatment provided as determined by the treating clinical team e.g., neural or orthopeadic
- Receiving palliative care or have a limited life expectancy
- Deemed unable or unnecessary to participate in upper limb intervention by the treating clinical team
- Treating Occupational Therapist and local allied health assistant declined to participate in the research preventing recording of usual care data
- Unable to follow basic instructions in English
- Group 2: Clinicians
- Clinicians expected to move into another clinical area within one month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Austin Health
Melbourne, Victoria, 3084
Sarah Newton, 61 03 94965105, sarah.newton@austin.org.au
About this study
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).
Read the 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?
- Conditions
- Stroke
- Being tested
- Real-time electronic data input into REDCap
- Keywords
- Usual care, Upper extremity, Dose, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time electronic data input into REDCapOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Sessions | Observed sessions for patients who are in the acute inpatient setting. Each session will include a patient and a clinician Receives: Other: Real-time electronic data input into REDCap | |
| Subacute Sessions | Observed sessions for patients who are in the subacute inpatient setting. Each session will include a patient and a clinician Receives: Other: Real-time electronic data input into REDCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of real-time electronic data input of usual care session dose
A single binary composite primary outcome, where feasibility is defined by 90% of sessions achieving ALL of:
- Binary outcome of Accuracy: ≤10% difference in dose between electronic data and second-rater data from a video recording of the session as defined by the decision algorithm.
- Binary outcome of Completeness: ≥90% of the electronic data completed by clinicians as defined by the decision algorithm.
- Binary outcome of Timeliness: ≤10% of session time is spent completing the electronic record or rated non-burdensome by the clinician as defined by the decision algorithm.
Measured: Each feasibility session will take up to one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Hayward, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527261
- Sponsor's protocol ID
- HREC/107078/Austin-2024
- Acronym
- eCARE4Stroke
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
- ClinicalTrials.gov ID
- NCT06527261
- Acronym / sponsor ID
- eCARE4Stroke / HREC/107078/Austin-2024
- Conditions
- Stroke
- Keywords
- Usual care, Upper extremity, Dose, Rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Sessions | – | Other: Real-time electronic data input into REDCapObserved sessions for patients who are in the acute inpatient setting. Each session will include a patient and a clinician |
| Subacute Sessions | – | Other: Real-time electronic data input into REDCapObserved sessions for patients who are in the subacute inpatient setting. Each session will include a patient and a clinician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Stroke patients These participants will be selected from inpatients within the tertiary health service of Austin Health in Melbourne, Victoria, Australia. They may be located at the acute setting: Austin hospital, Or subacute setting: Heidelberg repatriation hospital or Royal Talbot rehabilitation Centre. Group 2: Clinicians Clinicians will be invited to participate if they are an Occupational Therapist or allied health assistant working at Austin health with the stroke patient population.
Key inclusion criteria (6 listed)
- Adults (≥18 years) with a new, first or consecutive stroke, confirmed on CT or MRI.
- Motor upper limb impairment defined by a Shoulder Abduction and Finger Extension (SAFE) score of 0 through 9.
- Able to consent for themselves.
- Likely to receive at least one upper limb intervention session as determined by the treating clinical team.
- Occupational therapist or allied health assistant working with the stroke population in an acute or subacute settings within Austin Health.
Key exclusion criteria (7 listed)
- Existing co-morbidities that limit upper limb function and usual care treatment provided as determined by the treating clinical team e.g., neural or orthopeadic
- Receiving palliative care or have a limited life expectancy
- Deemed unable or unnecessary to participate in upper limb intervention by the treating clinical team
- Treating Occupational Therapist and local allied health assistant declined to participate in the research preventing recording of usual care data
- Unable to follow basic instructions in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time electronic data input into REDCapDuring 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. | Other | Acute Sessions, Subacute Sessions |
Primary outcome
Feasibility of real-time electronic data input of usual care session dose
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: 1. Binary outcome of Accuracy: ≤10% difference in dose between electronic data and second-rater data from a video recording of the session as defined by the decision algorithm. 2. Binary outcome of Completeness: ≥90% of the electronic data completed by clinicians as defined by the decision algorithm. 3. Binary outcome of Timeliness: ≤10% of session time is spent completing the electronic record or rated non-burdensome by the clinician as defined by the decision algorithm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Hayward principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Hayward, PhD (+61 03 9035 5511, kate.hayward@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of real-time electronic data input of usual care session dose (time frame: Each feasibility session will take up to one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.