A Pilot Randomised Control Trial to determine the acceptability and feasibility of providing early intervention with the Omo Neurexa shoulder Orthoses when compared to usual practice, in reducing the development of Hemiplegic shoulder pain post stroke.

Not Applicable

• Conditions: Stoke; Shoulder pain; Stroke - Haemorrhagic; Musculoskeletal - Other muscular and skeletal disorders; Stroke - Ischaemic

• Registration Number: ACTRN12619000068167
• Lead Sponsor: epean Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-18
• Study Completion: 2020-01-08
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

First Cardiovascular Accident
Hemiparetic upper limb - manual muscle testing below 3/5 and unable to hold the shoulder at 90 degrees forward flexion for < 10 seconds.
No premorbid shoulder issues

Exclusion Criteria

Language or Cognitive deficits precluding the participant from being able to provide informed consent or self report on pain levels or issues with either device.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome - Acceptability will be evaluated by the percentage of participants who, (1) agreed to participate, (2) complied with wearing the support for the allotted time period per day (3) attended the follow up assessments. This will be recorded in two ways (1) self-report using a questionnaire at the assessment intervals - see below. (2) study records[12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment<br>];Composite outcome - Feasibility will be evaluated by (1) number of patients who met the inclusion criteria, (2) number of participants recruited from the total number screened, (3) Number of drop outs. This will be recorded via the study screening forms, consent forms and study records. [12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment];Composite outcome - Delays in initial transfer out of bed and compliance of nursing staff applying the supports will be evaluated via a medical record review.[ 12 weeks post enrolment]