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Trial registered on ANZCTR


Registration number
ACTRN12613000448741
Ethics application status
Approved
Date submitted
15/04/2013
Date registered
19/04/2013
Date last updated
30/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Can knee muscle activation be altered using modified clinical exercises in patients with osteoarthritis?
Scientific title
Does the activation of muscles crossing the knee change when comparing standard and modified clinical exercises in individuals with knee joint osteoarthritis?
Secondary ID [1] 282339 0
Nil
Universal Trial Number (UTN)
U1111-1141-9188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee joint osteoarthritis 288887 0
Condition category
Condition code
Musculoskeletal 289230 289230 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will need to complete a series of clinical exercises. Participants will be given specific instruction on how to perform each of the following exercises; heel raise, wall squat, straight leg raise and step up. This will allow participants time to become familiar with the exercise. Participants will perform a total of 4 exercises with 2 variations being assessed (Normal exercise/ Modified exercise). 1 set of 10 repetitions will be performed with 2minutes rest between each exercise. The participants will perform the activity with little instruction during the normal exercise, then repeat the exercise with specific modifications to you if this changes muscle activation. All exercises will only be performed on one occasion.

Performing the calf raise (CR) will require the participant to stand with both feet on edge of step, with the heels hanging off the edge (1). Keeping the body erect, rise onto the forefeet (2). Then slowly drop heels below level of the step and repeat (3). The modified calf raise (MCR); the participant will be asked to stand with both feet hip width apart on the edge of the step, with the heels hanging off the edge (1). Keeping the body in an erect position, rise up through the “big toe” (2). Then slowly drop heels below level of the step and repeat (3).

Performing the straight leg raise (SLR); the participant will be positioned in a supine position, where they will be asked to bend knee of the non-affected side to flatten for back support (1). Lock knee of the affect leg out straight and lift leg to a height parallel to the bent knee (2). Then lower leg until it touches the bed, and then lift again, ensuring that the knee remains straight (3). The modified exercise “45deg straight leg raise; the participant will be asked to lay a supine position with a bent knee of the non-affected side to flatten and support lumbar spine (1). Lock the knee of the affected leg out straight, and externally rotate the thigh by turning the “toes outwards 45deg” (2). Lift the leg a height just below the opposite bent knee (3). Then lower leg until it touches the bed, and then lift again, ensuring that the knee remains straight (4).

Performing the Wall squat (WS); the participant will be positioned with their back against the wall (1). Placing the heels about thigh width from the wall and hip width apart (2). Ensuring that knee do not extend over toes slowly lower the trunk until the knees are bent through a 60deg range, progressing further as tolerated (3). The modified wall squat (MWS) will include a ball squeeze with pressure cuff to maintain equal squeeze pressure. Participants will be asked positioned with their back against the wall (1), Place the heel about thigh width from the wall and hip width apart (2). Place a ball with sphygmomanometer between the knees and measure the level of squeeze (3). Ensuring that knee do not extend over toes, slowly lower the trunk until the knees are bent through a 60deg range, progressing further as tolerated (4).

Performing the step up the participant will be asked to initially stand facing a step (step height=10-15cm)(1). Proceed to step up straight ahead with the affected leg, ensuring that the knee always remains on a line between the hip and foot until the unaffected foot is on the step (2). Emphasis should be placed on maintaining balance, correct upright posture, abdominal bracing, good knee alignment and pelvic/gluteal control (3). Slowly lower back down on the unaffected leg maintaining correct balance, knee alignment with abdominal and pelvic control and repeat (4). The modified variation step up will involve an altered foot position marked out a specific angle. The participant will be required to proceed to step up straight onto the taped angle with the affected leg, ensuring that the knee always remains on a line between the hip and foot until the unaffected foot is on the step (2). Emphasis should be placed on maintaining balance, correct upright posture, abdominal bracing, good knee alignment and pelvic/gluteal control (3). Slowly Lower back down on the unaffected leg while maintaining correct balance, knee alignment with abdominal and pelvic control and repeat (4).
Intervention code [1] 286955 0
Treatment: Other
Intervention code [2] 286956 0
Rehabilitation
Comparator / control treatment
Paitents will act as their own control by performing the activity under standard instructions. A healthy control group will also perform both sets of exercise to identify the effects of the pathology on the outcomes.
Control group
Active

Outcomes
Primary outcome [1] 289351 0
Co-contraction ratio between medial and lateral muscle groups. Muscle activation during the exercises will be collected with electromyography. Co-contraction ratios will be calculated post-hoc using custom software.
Timepoint [1] 289351 0
During the performance of the exercise. Electromyography records muscle activations during the performance of a task.
Secondary outcome [1] 302286 0
Total activation of all muscles crossing the knee. Muscle activation during the exercises will be collected with electromyography. Total activation will be calculated post-hoc using custom software.
Timepoint [1] 302286 0
During the performance of the exercise. Electromyography records muscle activations during the performance of a task.

Eligibility
Key inclusion criteria
Patient Group:
Medial compartment tibiofemoral compartment osteoarthritis scored as Kellgren and Lawrence Grade 3 or 4

Control Group
Asymptomatic
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Group:
Any neurological condition
Rheumatic disease other than osteoarthritis
Significant involvement of the lateral tibiofemoral compartment (Kellgren and Lawrence Grade 2 or higher)
Any other current lower limb injuries

Control Group
Any neurological condition
Rheumatic disease other than osteoarthritis
Osteoarthritis in the lower limb
Any other current lower limb injuries

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
Power analysis was used to calculate the population needed for this study. With a= 0.05, power of 0.9, this study we will need to recruit twelve participants per group based on similar previous research. However, due to the exploratory nature of the study we will inflate this to fifteen participants per group to ensure sufficient power.

Differences in co-contraction ration and total activation for each exercise and between groups will be analysed using a repeated measures MANCOVA with p set at 0.05. If there are differences on the main or interaction effects a Tukey’s post-hoc test will be performed. Co-contraction ratios during gait, Pain subscale from KOOS and knee alignment scores will be used as covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287097 0
University
Name [1] 287097 0
Murdoch University
Country [1] 287097 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 285874 0
None
Name [1] 285874 0
Address [1] 285874 0
Country [1] 285874 0
Other collaborator category [1] 277354 0
Commercial sector/Industry
Name [1] 277354 0
Hollywood Functional Rehabilitation Clinic
Address [1] 277354 0
Hollywood Functional Rehabilitation Clinic
P.O. Box 7273
Shenton Park WA 6008
Country [1] 277354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289111 0
Murdoch Univeristy Human Research Ethics Committee
Ethics committee address [1] 289111 0
Ethics committee country [1] 289111 0
Australia
Date submitted for ethics approval [1] 289111 0
Approval date [1] 289111 0
12/04/2013
Ethics approval number [1] 289111 0
2013/045

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39302 0
Dr Alasdair Dempsey
Address 39302 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch WA 6153
Country 39302 0
Australia
Phone 39302 0
+61 9360 6526
Fax 39302 0
Email 39302 0
a.dempsey@murdoch.edu.au
Contact person for public queries
Name 39303 0
Alasdair Dempsey
Address 39303 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch WA 6153
Country 39303 0
Australia
Phone 39303 0
+61 9360 6526
Fax 39303 0
Email 39303 0
a.dempsey@murdoch.edu.au
Contact person for scientific queries
Name 39304 0
Alasdair Dempsey
Address 39304 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch WA 6153
Country 39304 0
Australia
Phone 39304 0
+61 9360 6526
Fax 39304 0
Email 39304 0
a.dempsey@murdoch.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.