Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04589702 |
Other study ID # |
(P.T.Rec/012/001659) |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2019 |
Est. completion date |
September 30, 2020 |
Study information
Verified date |
October 2020 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Objective: To compare the temporal muscle activation between females with PF OA and normal
controls during stair ascent. Methods: An observational comparative study was conducted with
thirty-one females with PF OA and 11 healthy ones. The onset times of multifidus, transversus
abdominus (TrA), gluteus medius (GM), and vasti muscles were measured by quantitative
Electromyography during stair ascent task. hypothesis: Investigators hypothesized that there
won't be a significant difference between females with PF OA and their matched healthy group
regarding the onset times of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus
medius (GM), multifidus, and transversus abdominus (TrA), during stair ascent task.
Description:
Investigators collected the EMG activity of VMO, VL, GM, multifidus, and TrA using bipolar
Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited,
Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system
(Biomation, Almonte, Canada). Electromyographic data were sampled at 1000 Hz and bandpass
filtered at 50-200 Hz.
For each muscle, three electrodes were used; two electrodes were placed ~ 30 mm apart in the
direction of the muscle fibers and a ground electrode was placed over the closest bony
prominence. Before placement of the electrodes, the subject's skin was cleaned with alcohol
to reduce impedance and excess hair was removed to eliminate shifting of the electrodes if
needed.
The stair-stepping task consisted of ascending 2 steps (each step was 40 cm in width, 20 cm
in height, without handrails. The depth of the first and second steps was 30 cm and 40 cm,
respectively) . Participants were asked to stand on the floor confronting the stairs and 20
cm away from the edge of the initial step. The stair ascent task was performed barefooted
while arms hanged at the side of the body. Patients started ascending the steps immediately
in response to a command, at their normal speed with their affected limb. Investigators
didn't control the speed of stair ascent, because controlling the timing of stair-stepping
can alter the electromyographic signal as shown earlier for gait in asymptomatic subjects.
Healthy subjects started ascending stairs with their dominant limb .
Before data acquisition, participants performed one practice trial of stair ascent to get
familiarized with the task. Then the participants performed three test trials with thirty
seconds of rest after each trial to prevent fatigue. The raw data were stored on a personal
computer for analysis with a custom program in Matlab (Math Works, Natick, Massachusetts,
USA). Investigators used a mean of data in three trials for analysis.
Statistical Analysis:
Data management and analysis were conducted using the statistical package for social studies
(SPSS) version 22 for windows (IBM SPSS, Chicago, IL, USA). Normal distribution of the data
was tested using the Shapiro-Wilk test. The homogeneity of variances between groups was
examined using Levene's test. Descriptive data are expressed as mean ± standard deviation. An
independent t-test was conducted for comparison of subject characteristics; age, body mass
index (BMI), weight and height, between both groups. A univariate test of one way MANOVA was
performed to compare EMG onset of each muscle between both groups. Post-hoc analysis using
the Bonferroni method was carried out for subsequent multiple comparison. The level of
significance for all statistical tests was set at p < 0.05.