Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Melbourne
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Real-time electronic data input into REDCap
Other interventionDuring 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.
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Acute Sessions1 intervention
Group B: Subacute Sessions1 intervention
Trial outcomes
Primary outcomes
1
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: 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.
Time frame
Each feasibility session will take up to one hour.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: