Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000068167
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
18/01/2019
Date last updated
11/03/2020
Date data sharing statement initially provided
18/01/2019
Date results information initially provided
11/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 295330 0
Nil known
Universal Trial Number (UTN)
U1111-1220-9434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stoke 309776 0
Shoulder pain 309777 0
Condition category
Condition code
Stroke 308568 308568 0 0
Ischaemic
Stroke 308569 308569 0 0
Haemorrhagic
Musculoskeletal 308570 308570 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312487 0
Treatment: Devices
Comparator / control treatment
The control group will be receiving the usual device which is a hemi sling.
Control group
Active

Outcomes
Primary outcome [1] 307526 0
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
Timepoint [1] 307526 0
12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment
Primary outcome [2] 318721 0
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.
Timepoint [2] 318721 0
12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment
Primary outcome [3] 318722 0
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.
Timepoint [3] 318722 0
12 weeks post enrolment
Secondary outcome [1] 352209 0
Pain will be measured using the Numerical Pain Rating Scale (NPRS); 0 represents no pain and 10 is extreme pain. This will be measured at rest and during passive external rotation The NPRS is widely used scale for assessing pain and is considered to be more practical and understandable than other available methods (Li-ling Chuang et al 2014). This is a validated and widely used pain scale.
Timepoint [1] 352209 0
12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment.
Secondary outcome [2] 365745 0
Contracture will be determined by measuring the difference in ROM between the intact side and the hemiparetic side. This will be conducted via Goniometry which is a standard non-invasive measuring procedure and will follow a standardised protocol used in neurological assessment.
Timepoint [2] 365745 0
12 weeks post enrolment, assessed at 4 weekly intervals for the 12 weeks post enrolment
Secondary outcome [3] 365746 0
Upper limb spasticity will be measured using the Tardieu scale which is a standardised validated test routinely used in Neurological assessment. The presence of spasticity in the elbow flexor muscles is considered a precursor to the development of HSP. To evaluate if elbow flexor spasticity is present or develops in either one of these groups would be valuable information. Spasticity tests on the elbow extensors, wrist flexor & extensor muscle group will also be conducted as per standard neurological assessment as may provide supplementary information. This is a validated and widely used tool in Neurological assessment.
Timepoint [3] 365746 0
12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment
Secondary outcome [4] 365747 0
The assessment of muscle power is also fundamental in the hemiplegic upper limb assessment and will be measured using the Oxford Scale which is a 5-point scale representing the muscle activity for muscle group. This is the standard manual muscle testing tool used to test muscle strength. This is a validated and widely used method in Neurological assessment.
Timepoint [4] 365747 0
12 weeks post enrolment, assessed at 4 weekly intervals for 12 weeks post enrolment
Secondary outcome [5] 365748 0
Upper limb activity will be measured using items 6, 7 and 8 of the Motor Assessment Scale for stroke (Carr & Shepperd 1985) which is a globally accepted neurological outcome measure used by Neurological Physiotherapists. The results will be summed and reported as a score from 0 to 18, as per Preston et al (2016), where 0 is no upper limb activity and 18 is very good upper limb activity. This is a validated tool.
Timepoint [5] 365748 0
12 weeks post enrolment, assessed at 4 weekly intervals post enrolment
Secondary outcome [6] 365749 0
Observation and palpation of shoulder joint integrity will also be noted throughout the assessment process as per post stroke upper limb assessment to monitor for the development of subluxation. Though Ultrasonographical evaluation is considered the gold standard this method is beyond the scope of this pilot study and palpation is the current clinical practice measurement.
Timepoint [6] 365749 0
12 weeks post enrolment, assessed at 4 weekly intervals post enrolment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of the 20 participants is concealed in opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generator. This was completed by someone separate to the trial and therefore the principle investigator is unaware of allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics for acceptability and feasibility. The 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 (assessed using a self-report diary), (3) attended the follow up assessments. 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) time frame of intervention, (4) delays in initial transfer out of bed, (5) number of drop outs, (6) compliance of nursing staff applying the supports, (7) compliance of participants wearing the supports once discharged, (7) reports of deviation from the protocol.
Baseline characteristics for each group will be summarised as mean and standard deviations. A two-way repeated measures ANOVA will be used to assess changes in clinical measures over time for measured that are continuous variables (pain, range of motion) using factors; group (Control, Intervention) and time (baseline / 4 weeks / 8 weeks / 12 weeks). Categorical outcomes will be assessed as change scores (pre/post) using the chi square test.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
22/08/2018
Date of last participant enrolment
Anticipated
30/09/2019
Actual
8/01/2020
Date of last data collection
Anticipated
30/12/2019
Actual
8/01/2020
Sample size
Target
20
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 24135 0
2751 - Penrith

Funding & Sponsors
Funding source category [1] 299919 0
Hospital
Name [1] 299919 0
Nepean Hospital
Country [1] 299919 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
PO Box 63, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 299287 0
None
Name [1] 299287 0
Address [1] 299287 0
Country [1] 299287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300788 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 300788 0
Nepean Hospital
PO Box 63, Penrith NSW 2751
Ethics committee country [1] 300788 0
Australia
Date submitted for ethics approval [1] 300788 0
30/01/2018
Approval date [1] 300788 0
08/05/2018
Ethics approval number [1] 300788 0
HREC/18/NEPEAN/10

Summary
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.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84822 0
Mrs Bernadette Dutton
Address 84822 0
Allied Health Directorate
NBMLHD Education and Training Service (ETS)
Nepean Blue Mountain Local Health District
Nepean 2 Building, Nepean Hospital
PO Box 63, Penrith NSW 2751
Country 84822 0
Australia
Phone 84822 0
+61 02 4734 1694
Fax 84822 0
+61 02 4734 3748
Email 84822 0
bernadette.dutton@health.nsw.gov.au
Contact person for public queries
Name 84823 0
Mrs Bernadette Dutton
Address 84823 0
Allied Health & Community Programs Directorate
NBMLHD Education and Training Service (ETS)
Nepean Blue Mountain Local Health District
Nepean 2 Building, Nepean Hospital
PO Box 63, Penrith NSW 2751
Country 84823 0
Australia
Phone 84823 0
+61 02 4734 1694
Fax 84823 0
+61 02 4734 3748
Email 84823 0
bernadette.dutton@health.nsw.gov.au
Contact person for scientific queries
Name 84824 0
Mrs Bernadette Dutton
Address 84824 0
Allied Health & Community Programs Directorate
NBMLHD Education and Training Service (ETS)
Nepean Blue Mountain Local Health District
Nepean 2 Building, Nepean Hospital
PO Box 63, Penrith NSW 2751
Country 84824 0
Australia
Phone 84824 0
+61 02 4734 1694
Fax 84824 0
+61 02 4734 3748
Email 84824 0
bernadette.dutton@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected is de-identified and will be collated for results purposes


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1073Study protocol    375441-(Uploaded-16-01-2019-11-14-07)-Study-related document.docx
1074Informed consent form    375441-(Uploaded-16-01-2019-11-15-02)-Study-related document.doc
1075Ethical approval    375441-(Uploaded-16-01-2019-11-15-18)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.