Clinical trial NCT06527261: Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Official title: Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Keywords: Usual care
Upper extremity
Dose
Rehabilitation
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

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?

Eligibility criteria: Group 1: Stroke patients

Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Feasibility of real-time electronic data input of usual care session dose
timeFrame: Each feasibility session will take up to one hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Kate Hayward
role: PRINCIPAL_INVESTIGATOR
References: