ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000255684

Ethics application status

Approved

Date submitted

21/02/2023

Date registered

9/03/2023

Date last updated

9/03/2023

Date data sharing statement initially provided

9/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Reliability of knee-extensor strap stabilisation

Scientific title

A reliability study in Inclusion Body Myositis (IBM) to evaluate knee extensor strength using a stabilisation strap

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inclusion Body Myositis

Condition category

Condition code

Neurological

Other neurological disorders

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All interventions will be delivered during a single study visit at the study site, Murdoch University. This study visit will take approximately 2 hours.

All participants will undergo identical initial stages during which they will be asked to provide written informed consent, undergo screening, and provide demographic data.

All participants will then have knee-extensor strength assessed using the clinical reference standard, the Humac Norm.

Knee-extensor strength will then be assessed using the measurement methods being compared. Arm 1 will be assessed first using the Strap Stabilised Handheld Dynamometry (SSHD) and then the Operator Stabillised Handheld Dynamometry (SSHD), while Arm 2 will be assessed in the reverse order: first using the OSHD and then the SSHD.

Interventions are as follows with approximate time frames. Note that the order of OSHD and SSHD will vary.

1. Written informed consent and collection of demographic data (deidentified data including initials, sex, birth month and year), including medical information related to IBM diagnosis, duration of disease and use of mobility aids. (Approx. 20 mins)
2. Isokinetic dynamometer (Humac Norm) testing (Approx. 20 mins, including 10 mins rest prior)
3. Operator-stabilised handheld dynamometer (OSHD) utilising Citec hand-held precision digital force gauge CT 3002/30 (Approx. 15 mins, including 10 mins rest prior)
4. Strap-stabilised handheld dynamometer (SSHD) (Approx. 15 mins, including 10 mins rest prior)

The participant will have an opportunity to have some light refreshments and rest before leaving the unit.

Further information is provided on the Strap-Stabilised Handheld Dynamometry (SSHD) and Operator Stabilised Handheld Dynamometry (OSHD):

Operator-stabilised handheld dynamometer (OSHD)
Also known as a handheld dynamometer, this is the standard currently in use for objective muscle strength testing in clinical practice settings. These are portable, handheld devices capable of assessing various muscle groups. The participant performs a maximal effort action against the device whilst the operator holds the device stationary, resisting the action. This study will utilise the Citec hand-held precision digital force gauge CT 3002/30.

Strap-stabilised handheld dynamometer (SSHD)
The novel method being assessed in this trial. This method utilises the same handheld dynamometer as described above. Instead of the operator stabilising the device, a strap is used to stabilise the device. The strap is attached to the handheld dynamometer and then fixed to the frame of the plinth or chair where the participant is seated. This method is used specifically when assessing knee extension.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Intervention code [3]

Treatment: Devices

Comparator / control treatment

All interventions will be delivered during a single study visit at the study site, Murdoch University.

Two methods of hand-held dynamometry will be assessed against the industry 'gold standard', the Humac Norm.

Isokinetic dynamometer (Humac Norm):
The Humac Norm is a computer-assisted fixed force plate machine which is considered the gold-standard measurement in muscle strength testing. It will be used as the clinical reference standard for assessment of validity of each method of handheld dynamometry. The participant is seated in a padded chair and stabilised with straps across the torso, waist, and thigh. The participant is asked to perform a maximal effort knee-extension against a padded, rigid force-plate. Study participants will be asked to perform three maximal effort knee extensions on each leg (3 x right leg, followed by 3 x left leg). Each effort will last three seconds, with 60 seconds rest in between. All efforts will be recorded in the study database. Force will be recorded in Newton-metres.

This intervention will be administered by a trained, delegated member of the study team in accordance with study standard operating procedures. The same team member will perform Humac Norm testing for all study participants to limit inter-rater variability.

At least 10 minutes of rest will be given prior to Humac Norm administration.

The Humac Norm will be the first intervention administered for all participants.

Control group

Active

Outcomes

Primary outcome [1]

Reliability of Strap Stabilised Handheld Dynamometry (SSHD) scores of knee extensor strength, compared to reliability Operator Stabilised Handheld Dynamometry (OSHD) scores, when measured against Isokinetic knee extensor strength testing (Humac Norm) in the IBM population. This will be measured using a test-retest analysis of both methods.

Timepoint [1]

All three measures of knee extensor strength will be collected during a single study visit (timepoint).

Secondary outcome [1]

The validity of knee extensor strength testing using both SSHD and OSHD in the IBM population. Validity will be assessed by comparing each handheld dynamometry method against the ‘gold’ standard isokinetic dynamometer (Humac Norm).

Timepoint [1]

All three measures of knee extensor strength will be collected during a single study visit (timepoint).

Eligibility

Key inclusion criteria

•Age at least 18 years or over
•Has a confirmed diagnosis of Inclusion Body Myositis by a neuromuscular specialist
•Able to attend the a single study visit of approximately 3 hours duration during the study period
•Able to provide written informed consent for the study
•Able to independently and safely transfer on and off the Humac Norm
•Knee extensor modified Medical Research Council grade of at least 4- in one or both legs as assessed within the past 6 months.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

•Recent history (within six months) of fracture or pathology affecting the knee joint that would reasonably cause pain or discomfort or prevent the participant from performing a resisted knee extension.
•Any condition precluding the participant from performing any part of the study procedures.
•Any clinical assessment by the Sponsor-Investigator that the participant is unable or unsafe to take part in the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sequence allocation is revealed on registration of the participant on the study database following receipt of informed consent.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomly allocated to one of two sequences of testing for the handheld dynamometry testing. Participants will either undergo testing with a SSHD followed by OSHD, or vice versa. The allocation of participants to each sequence will be determined by block randomisation. A study team member not directly involved in intervention measurement or analysis of the study results will prepare the randomisation schedule to maintain balance between study arms.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample Size Calculation Methods
The target sample size for this study will be 30 participants.

Based on the data (r=.86) from Bohannon et al (2011) along with the assumption that greater variance may be observed amongst our clinical cohort, we have opted to employ a correlation of 0.8 (with an upper critical r of .74; using correlation of p H0=0.5) for our sample size analysis. Using a two-tailed analysis, with the alpha error probability set at 0.05 and a power of 0.8, we require a minimum sample size of N=29.

The publicly available software, G*Power (version 3.1) was used for this power calculation.

Data Analysis Methods

Baseline Descriptive Statistics
The distributions of demographic and clinical characteristics will be described for the overall cohort using standard summary statistics

Analysis of Fatiguability
An independent sample t-test will be run to compare intra-device variability for the SSHD and OSHD between crossover arms. This assessment will provide an understanding of whether further statistical adjustment is required to account for potential participant fatigue affecting the third method of measurement compared to the second.

Analysis of the Primary Outcome
Test-retest reliability will be assessed for both the OSHD and the SSHD by calculating a bivariate Pearson correlation coefficient (r) and corresponding p-values for intra-participant efforts on each method. If p<.5 and r>.7 the test will be deemed reliable. If p>.5 or r<.7 then researchers do not have evidence of test-retest reliability.

Prior to calculating r, the assumptions of normality, linearity and homoscedasticity will be assessed.

An Intraclass Correlation Coefficient (ICC) will also be generated to assess test-retest reliability. The ICC will be generated using a single measurement, absolute agreement, 2-way mixed-effects model. This will be reported as an ICC and a 95% confidence interval. The ICC will be interpreted using the ranges suggested by Koo & Li (2016).

Secondary Outcome
Two statistical analyses will be performed to assess validity of the SSHD and OSHD: a Pearson correlation coefficient and a Bland-Altman plot.

A bivariate Pearson’s product-moment correlation coefficient (r) will be calculated for both the SSHD and the OSHD (against the isokinetic dynamometer) to assess for the direction and strength of the relationship of each handheld dynamometry method with the ‘gold’-standard.

Bland-Altman plots will be used to assess agreement of each of the handheld dynamometer methods (the SSHD and OSHD) against the ‘gold’ standard.

Two Bland-Altman plots will be generated: one comparing the SSHD with the isokinetic dynamometer and one comparing the OSHD with the isokinetic dynamometer. The assumption of normal distribution will first be assessed. The participant’s mean muscle force measurement (in Newton-meters) for each method will be used for these calculations. The limits of agreement will be assessed as a 95% confidence interval.

References
Bohannon RW, Bubela DJ, Wang Y, Magasi SR, Gershon RC. Adequacy of Belt-Stabilized Testing of Knee Extension Strength. J Strength Cond Res. 2011;25(7):1963-1967. doi: 10.1519/JSC.0b013e3181e4f5ce

Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15:155-163. doi: 10.1016/j.jcm.2016.02.012

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/05/2023

Actual

Date of last participant enrolment

Anticipated

31/12/2023

Actual

Date of last data collection

Anticipated

31/12/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Perron Institute for Neurological and Translational Science - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch University

Address [1]

90 South Street
Murdoch
WA 6150

Country [1]

Australia

Primary sponsor type

University

Name

Murdoch University

Address

90 South St, Murdoch WA 6150

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Notre Dame Australia

Address [1]

32 Mouat St, Fremantle WA 6160

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Human Research Ethics Committee

Ethics committee address [1]

Murdoch University
Chancellery Building Room 1.006
South Street, Murdoch
Western Australia 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/01/2023

Approval date [1]

01/03/2023

Ethics approval number [1]

2023/013

Summary

Brief summary

Inclusion Body Myositis (IBM) is the most common inflammatory muscle disease affecting people aged over 50. Weakness of knee-extensors is characteristic of IBM and knee-extensor strength is frequently used as a key outcome measure to track disease progression and response to interventions in clinical practice and clinical trials. Currently, there exists ambiguity over the best and most practical measurement tool for this purpose. 

The aim of this study is to assess and compare two methods of portable dynamometry that each measure knee-extensor strength in IBM patients. One of these methods, operator-stabilised handheld dynamometry (OSHD), is the current clinical standard for objective assessment of knee extensor strength in IBM, however this method can be influenced by limb position and operator strength. The second method, strap-stabilised handheld dynamometry (SSHD) addresses the shortcomings of OSHD by utilising a stabilisation strap to hold the handheld dynamometer in place. 

A crossover design for testing sequence will be used to assess reliability of SSHD as compared to OSHD for knee-extensor testing. Validity of both methods will also be assessed by comparing both OSHD and SSHD to the clinical reference (‘gold’) standard, an isokinetic dynamometer. This design has been chosen to collect data that will enable assessment of both reliability and validity of these methods using the participant as a control. It will enable the comparison of the use of SSHD in this population as compared to OSHD and constitutes a pivotal study in the assessment of this method of dynamometry.
  
All participants will be asked to present for a single testing visit (approximately 3 hours duration), at which eligibility screening will be conducted, written informed consent will be received, and testing will occur. There are no follow-up measures or interventions. 

Participants are only required to attend the single testing session, which minimises burden on participants and maximises study accessibility. Participants will be randomly allocated to one of two study visit sequences, which differ in the order of testing of OSHD and SSHD.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Merrilee Needham

Address

Murdoch University
90 South Street
Murdoch
WA 6150

Country

Australia

Phone

+610893601334

Fax

+610893601680

merrilee.needham@health.wa.au

Contact person for public queries

Name

Kelly Beer

Address

Murdoch University
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+610893601365

Fax

+610893601680

kelly.beer@murdoch.edu.au

Contact person for scientific queries

Name

Kelly Beer

Address

Murdoch University
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+610893601365

Fax

+610893601680

kelly.beer@murdoch.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices)
Study protocol, PICF, study specific Standard Operating Procedures

When will data be available (start and end dates)?

Beginning 6 months following analysis and subsequent publication of the study; no end date determined

Available to whom?

Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept the Sponsoring Institutions’ conditions for access.

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Access subject to approval by Principal Investigator. The Principal Investigator can be contacted via the Clinical Research Manager, Kelly Beer:

kelly.beer@murdoch.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Other Details
18097	Study protocol	Will be published once approved by ethics and also... [More Details]
18098	Informed consent form	Will be available via email request to the study t... [More Details]
18099	Ethical approval	Will be available via email request to the study t... [More Details]

Results publications and other study-related documents

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