NCT06527261Not yet recruiting
Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke
Source: ClinicalTrials.gov · Last updated 30 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 146 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- Jul 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Melbourne
- Diseases
- Stroke
- NCT number
- NCT06527261
What you commit to
- Study type: Observational
- Planned participants: 146
- From Jul 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving palliative care or have a limited life expectancy
Other
- 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
- 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.
Who the study is looking for
- 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
Criteria the registry did not label
- Group 1: Stroke patients
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.