Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001030561
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
1/10/2015
Date last updated
23/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability and validity of a wearable electromyography system in individuals with patellofemoral pain syndrome
Scientific title
Is wearable electromyography system (Mshorts) a reliable and valid tool for assessing individuals with and without patellofemoral pain?
Secondary ID [1] 287408 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals with patellofemoral pain syndrome and people with no knee pain (pain free). 296113 0
Condition category
Condition code
Musculoskeletal 296372 296372 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Purpose of this study is to analyse the reliability and validity of the Mshorts (a wearable EMG) in individuals with patellofemoral pain syndrome and those with no knee pain. Therefore, volunteers will wear a pair of shorts with sensors that measure muscle contraction (the Mshorts) and they will perform three tasks, including 10 repetitions of each: (1) full squat test, (2) stair climbing and (3) single leg squat test. Muscle activation of the quadriceps and hamstrings will be analyzed. The participants will perform trials in the same manner on two different days for reliability analysis, with an interval of 2 to 7 days between the 2 collection dates.
Intervention code [1] 292760 0
Not applicable
Comparator / control treatment
The comparator will be a group with no patellofemoral pain.
Control group
Active

Outcomes
Primary outcome [1] 296019 0
Primary outcome 1: EMG of the quadriceps muscle (MQ), assessed by the MShorts. The shorts contain embedded EMG sensors, that measure muscle activity during functional activities. Data will be collected during full squat, stair climbing and single leg squat test
Timepoint [1] 296019 0
Timepoint for the three primary outcomes is the same. The participants will perform bilateral trials that will be performed, in the same manner, on two different days for reliability analysis, with an interval of 2 to 7 days between the 2 collection dates.
Primary outcome [2] 296120 0
Primary outcome 2: EMG of the hamstrings muscle (MH), assessed by the MShorts. The shorts contain embedded EMG sensors, that measure muscle activity during functional activities. Data will be collected during full squat, stair climbing and single leg squat test
Timepoint [2] 296120 0
The participants will perform bilateral trials that will be performed, in the same manner, on two different days for reliability analysis, with an interval of 2 to 7 days between the 2 collection dates.
Primary outcome [3] 296121 0
Primary outcome 3: EMG of the quadriceps and hamstrings muscle (MQ and MH), assessed by the MShorts. The shorts contain embedded EMG sensors, that measure muscle activity during functional activities. Data will be collected during full squat, stair climbing and single leg squat test
Timepoint [3] 296121 0
The participants will perform bilateral trials that will be performed, in the same manner, on two different days for reliability analysis, with an interval of 2 to 7 days between the 2 collection dates.
Secondary outcome [1] 317254 0
None
Timepoint [1] 317254 0
None

Eligibility
Key inclusion criteria
A. Participant is willing and able to give informed consent for participation in the study.
B. Male or Female, aged 18 to 40 years old.
C. Diagnosed with PFPS: complaining of knee pain for at least 1 month with an insidious start and healthy volunteers with no knee pain
D. Participants able to perform physical activity such as stair climbing and squat tests.
E. Able and willing to comply with all study requirements.
F. Participants with PFPS must present: (1) anterior knee pain during at least 2 of the following activities: kneeling, squatting, climbing stairs, jumping, running, and remaining seated; (2) symptoms for at least 1 month with an insidious start; (3) pain during patellar palpation; (4) pain level up to 3cm on a 10-cm visual analogic scale (VAS) in the previous week; and (5) at least 3 positive clinical signs of the following tests: Clarke’s sign, Waldron, McConnell, Zohler’s sign, Noble compression, Q angle higher than 18 degrees, and patella in the medial or lateral position. The participants need to fulfil all 5 requirements to be allocated to the PFPS group and could not present any signs or symptoms of PFPS or other disease to be allocated to the control group (pain-free).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A. Pregnancy during the course of the study.
B. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
C. Participants are not able to perform the tests and present other condition as patellar tendon or meniscus tears, ligament tears, bilateral knee pain, bursitis, chondral lesions or osteoarthritis, dislocation or patellar subluxation, presence of neurological diseases, or inflammatory processes
D. Participants who received oral steroids, steroid injections, opiate treatment, acupuncture or physiotherapy during the last 6 months.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sixty individuals will be recruited. This sample size was calculated from two previous studies, in which the purpose was to analyse EMG changes of the EMG signal in patients with PFPS and between the two types of squat. Based on previous research we performed on EMG differences between people with and without PFPS (Ferrari 2014) we used an effect size of 0.75. Results with the greatest standard deviation and greatest detected difference were used for sample calculation, with a test power of 80% (1-beta=0.80) and a=0.05, two tail.
The descriptive values (means +/- SDs) will be obtained using SPSS software version 18. The data will be analyzed for normality of distribution using the Shapiro-Wilk W test. Independent t tests and analyses of variance will be used to identify the differences between groups. For a relative measure of reliability, the intraclass correlation coefficient (ICC) and the kappa statistic will be used (Weir 2005). ICC values in the .00 to .25 range indicate little, if any, reliability; the .26 to .49 range indicate poor reliability; the .50 to .69 range indicate moderate reliability; the .70 to .89 range indicate high reliability; and the .90 to 1.0 range indicated very high reliability (Mathur et al. 2005; Kellis and Katis 2008). The standard error of measurement (SEM) will be used to express the reliability in absolute values (Weir 2005), indicating the precision of the measurement (Denegar and Ball 1993). A low SEM indicates better reliability of the measurement (Kellis and Katis 2008). After calculating the reliability of the EMG parameters, the diagnostic accuracy will be determined. The term accuracy refers to the amount of agreement between the information from the reference standard and the index test (Bossuyt et al. 2004). To examine the diagnostic accuracy value of the index test, the sensitivity, specificity, positive and negative predictive values (PPVs and NPVs), and positive and negative likelihood ratios (LR+ and LR-) will be calculated (Jaeschke et al. 1994; Fritz and Wainner 2001).
Noteworthy, reference standard is defined as the best-available method to determine the absence or presence of the condition of interest (Bossuyt et al. 2004). In this study, the reference standard will be the diagnostic criteria listed earlier (inclusion criteria). The index test, which is the test under evaluation (Bossuyt et al. 2004), will be the EMG signal obtained from Mshorts during tasks such as full squat test, step up test and single leg squat test. EMG parameters should be reliable, precise, and able to differentiate participants with PFPS and pain-free participants. The time interval between the assessments by the reference standard and the index test is up to 1 week.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
17/11/2015
Date of last participant enrolment
Anticipated
Actual
13/12/2015
Date of last data collection
Anticipated
Actual
17/12/2015
Sample size
Target
60
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291978 0
Self funded/Unfunded
Name [1] 291978 0
Country [1] 291978 0
Primary sponsor type
Individual
Name
Deisi Ferrari
Address
University of Sao Paulo State
Rua Roberto Simonsen, 305 – Jardim das Rosas Presidente Prudente – Sao Paulo - Brazil Postal Code (CEP): 19060-900
Country
Brazil
Secondary sponsor category [1] 290655 0
Individual
Name [1] 290655 0
Evangelos Pappas
Address [1] 290655 0
Room O153
Block O (Cumberland Campus)
The University of Sydney
75 East St - Lidcombe 2141
NSW - AUSTRALIA
Country [1] 290655 0
Australia
Secondary sponsor category [2] 290672 0
Individual
Name [2] 290672 0
Fabio Micolis de Azevedo
Address [2] 290672 0
Rua Roberto Simonsen, 305 – Jardim das Rosas
Presidente Prudente – Sao Paulo - Brazil
Postal Code (CEP): 19060-900
Country [2] 290672 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293485 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293485 0
Research Integrity & Ethics Administration
THE UNIVERSITY OF SYDNEY
Level 2- Margaret Telfer Building (K07)
The University of Sydney - NSW - 2006
Ethics committee country [1] 293485 0
Australia
Date submitted for ethics approval [1] 293485 0
06/08/2015
Approval date [1] 293485 0
20/10/2015
Ethics approval number [1] 293485 0

Summary
Brief summary
The purpose of this study is to analyze the reliability and validity of the Mshorts (a wearable EMG) in individuals with patellofemoral pain syndrome and those with no knee pain. We hypothesized that the Mshorts is reliable and accurate tool to assess muscle activation in individuals with and without patellofemoral pain syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60038 0
Ms Deisi Ferrari
Address 60038 0
University of Sao Paulo State
Rua Roberto Simonsen, 305 – Jardim das Rosas Presidente Prudente – Sao Paulo - Brazil Postal Code (CEP): 19060-900
Country 60038 0
Brazil
Phone 60038 0
+55 18 981387437
Fax 60038 0
Email 60038 0
[email protected]
Contact person for public queries
Name 60039 0
A/Prof Evangelos Pappas
Address 60039 0
Evangelos Pappas
Room O153
Block O (Cumberland Campus)
The University of Sydney
75 East St - Lidcombe 2141
NSW - AUSTRALIA
Country 60039 0
Australia
Phone 60039 0
+61 2 9351 9188
Fax 60039 0
Email 60039 0
[email protected]
Contact person for scientific queries
Name 60040 0
Ms Deisi Ferrari
Address 60040 0
University of Sao Paulo State
Rua Roberto Simonsen, 305 – Jardim das Rosas Presidente Prudente – Sao Paulo - Brazil Postal Code (CEP): 19060-900
Country 60040 0
Brazil
Phone 60040 0
+55 18 981387437
Fax 60040 0
Email 60040 0
[email protected]

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