None listed
Conditions
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.
Interventions
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 usin
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.
Sponsors
Murdoch University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed