Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06527261




Registration number
NCT06527261
Ethics application status
Date submitted
11/07/2024
Date registered
30/07/2024
Date last updated
30/07/2024

Titles & IDs
Public title
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Scientific title
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Secondary ID [1] 0 0
HREC/107078/Austin-2024
Universal Trial Number (UTN)
Trial acronym
eCARE4Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Real-time electronic data input into REDCap

Acute Sessions - Observed sessions for patients who are in the acute inpatient setting. Each session will include a patient and a clinician

Subacute Sessions - Observed sessions for patients who are in the subacute inpatient setting. Each session will include a patient and a clinician


Other interventions: Real-time electronic data input into REDCap
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of real-time electronic data input of usual care session dose
Timepoint [1] 0 0
Each feasibility session will take up to one hour.

Eligibility
Key inclusion criteria
Group 1: Stroke patients



* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Inclusion criteria

* 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

Exclusion criteria:

• Clinicians expected to move into another clinical area within one month.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06527261
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Hayward
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kate Hayward, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 03 9035 5511
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06527261