Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000474055
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
10/06/2010
Date last updated
10/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of shoe heel height on lower limb muscles electromyography activity during sit to stand.
Scientific title
Effects of differents shoes on electromyographic activity evaluation of the patella muscles during squat exercise and stair ascent in individuals with and without patellofemoral pain syndrome
Secondary ID [1] 251938 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patellofemoral pain syndrome (PFPS) 257512 0
Condition category
Condition code
Musculoskeletal 257672 257672 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research is a cross-sectional study comparing the lower limb electromiographic (EMG) activation pattern between females with and without patellofemoral pain during sit to stand and ascent stair tasks. Subjects will be reported to the Laboratory for a single testing session.
After cleaning the skin with isopropyl alcohol, active surface
EMG recording electrodes (Ag/Ag Cl) will placed on quadriceps muscle, at standardized sites on the dominant leg, determined as the one with which they would kick a ball. A ground electrode will attached to distal tibial region . All electrodes will taped to the skin to reduce movement artifacts and remained in place throughout the study. EMG signals will sampled by a 12-bit A/D converter board with a 4 kHz frequency, and band-pass filtered at
0.01–1.5 kHz. Raw EMG data were digitally filtered at frequency bandwidth of 20–500 Hz and the root mean square (RMS) was calculated. Each group will realized two types of exercises. All subjects wearing differents shoes stood in front of the stair. The subjects were made ready
to ascend the stair with complete heel contact of the dominant leg, and when instructed to “start” they detached their opposite leg at a rate of 80 steps/min, stepping side to side for 3 s with the aid of a metronome.
Squats: Participants were seated on a standard chair of height 50 cm, with their feet a comfortable width apart. Foot position was kept the same between tests.
They were then asked to stand, in their own time without using their arms to assist, and remain standing until requested to sit. For all the requested activities, the volunteer will be using two different types of footwear: tennis and high-heeled shoes. The duration of study will be of 6 months. The approximate duration of the single testing session was 60-90 minutes (20 minutes with no shoes, 20 minutes with tennis shoes and 20 minutes with high-heeled shoes).The first 20 minutes involved performing a physical evaluation.
Intervention code [1] 256606 0
Not applicable
Comparator / control treatment
there is no treatment in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258576 0
This is a cross-sectional study without treatment. It will be evaluated the electromiographic activation from lower limb muscles in females with and without patellofemoral pain.
Timepoint [1] 258576 0
The EMG testing will be assessed during a single 90 minute testing session.
Secondary outcome [1] 264444 0
It will be evaluated the effect of differents shoes on EMG activity from lower limb muscles in females with and without patellofemoral pain.
Timepoint [1] 264444 0
The EMG testing will be assessed during a single 90 minute testing session.

Eligibility
Key inclusion criteria
Inclusion criteria for the patellofemoral pains syndrome group will be as follow: anterior or retropatellar knee pain during at least three of the following activities: ascending/descending stairs, squatting, running, kneeling, hopping/jumping and prolonged sitting; insidious onset of symptoms being unrelated to a traumatic incident; pain during at least four weeks; and the presence of pain on palpation of the patellar facets.

Inclusion criteria for the healthy participants group will be as follow: Participants without pain or previous surgery of the lower limb.
Minimum age
18 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects from both the PFPS and control groups will be excluded if they show signs or symptoms of any of the following: meniscal or other intra-articular pathological conditions; patellar apprehension sign; history of patellar dislocation; or previous surgery of the knee joint.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2678 0
Brazil
State/province [1] 2678 0

Funding & Sponsors
Funding source category [1] 257099 0
University
Name [1] 257099 0
University of Pernambuco
Country [1] 257099 0
Brazil
Primary sponsor type
University
Name
University of Pernambuco
Address
Av. Agamenon Magalhaes S/N, Santo Amaro – Recife – PE
CEP 50.100-010
Country
Brazil
Secondary sponsor category [1] 256359 0
None
Name [1] 256359 0
Address [1] 256359 0
Country [1] 256359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259132 0
University of Pernambuco Ethics Commitee
Ethics committee address [1] 259132 0
Av. Agamenon Magalhaes S/N, Santo Amaro, Recife, PE
CEP 50.100-010
Ethics committee country [1] 259132 0
Brazil
Date submitted for ethics approval [1] 259132 0
Approval date [1] 259132 0
20/11/2009
Ethics approval number [1] 259132 0
1/09/0202

Summary
Brief summary
In our society, it is observed an increasing number of models, heights and types of high heels. The frequent use of high-heeled shoes can be responsible for alterations of the corporal mechanics. Considering the importance of appropriate support for the lower limbs, the aim of this study was to assess, by using EMG, whether the type of shoes has any influence on quadriceps muscles activity changes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31254 0
Address 31254 0
Country 31254 0
Phone 31254 0
Fax 31254 0
Email 31254 0
Contact person for public queries
Name 14501 0
Rodrigo Cappato de Araujo
Address 14501 0
BR 203 Km 2 S/N
Vila Eduardo
56300-000 - Petrolina, PE - Brasil
Country 14501 0
Brazil
Phone 14501 0
55 87 38614515
Fax 14501 0
Email 14501 0
rodrigo.cappato@upe.br
Contact person for scientific queries
Name 5429 0
Rodrigo Cappato de Araujo
Address 5429 0
BR 203 Km 2 S/N
Vila Eduardo
56300-000 - Petrolina, PE - Brasil
Country 5429 0
Brazil
Phone 5429 0
55 87 38614515
Fax 5429 0
Email 5429 0
rodrigo.cappato@upe.br

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

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Documents added automatically
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