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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.

A Pilot RCT 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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000068167
Enrollment
10
Registered
2019-01-18
Start date
2018-08-22
Completion date
2020-01-08
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To determine the acceptability and feasibility of providing the Omo Neurexa Shoulder Orthosis as an early intervention management strategy for protection of the shoulder joint post stroke compared to current care. The aim is to inform a future Randomised Control Trial to compare these two products and patient outcomes.

Interventions

This Pilot trial will be conducted in a single centre where the control group and intervention group will receive usual care that is already established as per ward protocol and best practice guidelines. The participants will be fitted with either the Actimove Hemisling (usual care/ contro) or the Omo Neurexa (Intervention) prior to transferring out of bed for the first time (early intervention). All patients will receive usual post stroke upper limb care (OT/PT) and the only change in their cli

This Pilot trial will be conducted in a single centre where the control group and intervention group will receive usual care that is already established as per ward protocol and best practice guidelines. The participants will be fitted with either the Actimove Hemisling (usual care/ contro) or the Omo Neurexa (Intervention) prior to transferring out of bed for the first time (early intervention). All patients will receive usual post stroke upper limb care (OT/PT) and the only change in their clinical management will be the selection of their shoulder support. The Shoulder supports will be provided to patients for the duration of time that they require shoulder support as assessed by their treating physiotherapist. Their follow up assessment sessions are in line with routine care, the only differences being that the assessing Physiotherapist will not know which support the patients are wearing. The Senior Stroke Unit Physiotherapist will be administering the intervention in terms of screening and fitting the device. The blind assessor is a Senior Neurological Physiotherapist and will be conducting assessments at 4 weekly intervals for 12 weeks in total. For the purpose of this trial, the patients and family will be reporting on adherence to the device via a questionnaire completed at each assessment, this is being conducted by the Principle Researcher prior to the physical assessment conducted by the blind assessor. The Orthoses being examined is the Omo Neurexa Shoulder Orthoses from Ottobock - ARTG Identifier - 289840. The Omo Neurexa is a shoulder Orthoses that is recommended as a firm support for the management of shoulder instability e.g. subluxation. The device has a elbow component that supports the weight of a Hemiplegic shoulder to prevent traction trauma of the Glenohumeral Joint. The device will be worn during waking hours when the patient is out of bed. An Actimove Hemisling will be provided for showering to ensure trauma protection.

Sponsors

Nepean Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026