Reliability and validity of a wearable electromyography system in individuals with patellofemoral pain syndrome

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001030561
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Deisi Ferrari
• 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?
• Date of first enrolment: 17/11/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001030561.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Evangelos Pappas

• Name: Ms Deisi Ferrari

Key inclusion & exclusion criteria

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).

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.


Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Individuals with patellofemoral pain syndrome and people with no knee pain (pain free).;
Individuals with patellofemoral pain syndrome and people with no knee pain (pain free).

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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.

Primary Outcome(s)

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 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: 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[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: 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[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(s)

None[None]

Secondary ID(s)

None

Secondary Sponsor(s)

Fabio Micolis de Azevedo

Evangelos Pappas

Ethics review

Status: Approved
Approval date:
Contact:

University of Sydney Human Research Ethics Committee