Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583434
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial was to determine if stabilization-based Pilates exercises could improve gait and balance in women with flexible flatfoot
The main questions it aimed to answer were
Did Pilates training improve gait parameters in women with flexible flatfoot Did Pilates training reduce balance instability in these participants
Researchers compared the Pilates training group to a non-training group The results showed significant improvements in gait and balance for those who participated in the Pilates training
Participants
Completed twice-weekly Pilates sessions for 8 weeks Underwent pre- and post-intervention assessments of gait and balance
The main questions it aimed to answer were
Did Pilates training improve gait parameters in women with flexible flatfoot Did Pilates training reduce balance instability in these participants
Researchers compared the Pilates training group to a non-training group The results showed significant improvements in gait and balance for those who participated in the Pilates training
Participants
Completed twice-weekly Pilates sessions for 8 weeks Underwent pre- and post-intervention assessments of gait and balance
Detailed Description:
Study object This randomized controlled trial aims to assess the effects of stabilization-based Pilates exercises on gait and balance in women with flexible flatfoot The study focuses on determining whether a specific Pilates program can provide non-invasive rehabilitation for improving gait patterns and reducing balance instability
Participants The study will include 22 healthy women with flexible flatfoot who have no congenital deformities or diseases of the feet knees and have a navicular drop of 10 mm The participants will be recruited from Clinical Pilates studio in Busan city Women with bilateral flatfoot n22 will be randomly allocated to either the Pilates training group PTG n11 or the non-training group NTG n11
Outcome measure gait assessment and data acquisition Participants undergo several practice walks to familiarize themselves with the gait assessment Three records are averaged once they show a normal gait pattern The assessment uses measurements from both legs and is conducted in a non-distracting environment
Seven 3D infrared motion capture cameras Vicon camera MX-T20 Oxford Metrics Oxford UK and 16 circular reflective markers 14-mm diameter are used to acquire the data for the gait assessment The reflective markers are attached to the anterior superior iliac spine posterior superior iliac spine lateral mid-thigh lateral femoral epicondyle mid-shin lateral malleolus second metatarsus and heel of both the left and right legs The height body weight and width of knee and ankle joints are measured and entered Gait analysis includes temporal parameters such as foot-off step time stride time walking speed and cadence Kinematic data are collected using Vicon plug-in gait system Oxford Metrics at a sampling frequency of 100 Hz
balance assessment and data acquisition The participants are instructed to stand with their arms crossed in front of their chest with one leg supported and one leg raised with the knee at a 90 angle Participants hold that standing position for 40 seconds Three successful attempts are recorded for each participant Measurements are taken for both legs and the participants are given sufficient time to rest between each stage of the experiment
For Center of Pressure COP measurement data from 40 seconds of single leg support on a force platform AMTI-OR6 Watertown MA USA are utilized The data are calculated and assessed as time series data COP sway variability is assessed based on the Root Mean Sqaure RMS in Anterior-Posterior AP and Medial-Lateral ML directions while AP and ML components of COP velocity and range are also assessed Kinematic data are collected using the Vicon Plug-in Gait system at a sampling frequency of 100 Hz
Exercise intervention
The exercise intervention consists of two sessions each week for a total of 16 sessions over an 8-week period Each training session is structured into eight sets totaling 50 minites This includes a 5-min warm-up period followed by 40-min of the main exercise component and concluding with a 5-min cool-down phase The Pilates training is supervised by an instructor with 15 years of experience and a professional Pilates certification
Statistical analysis IBM SPSS Statistics for Windows version 280 IBM Corp Armonk NY USA is used to conduct descriptive statistical analyses including means and standard deviations Statistical significance is set at p005
Differences in mean values between the groups for each temporal parameter will be assessed using independent samples t-tests Additionally due to the small sample size non-parametric tests Mann-Whitney U test will be conducted Furthermore paired samples t-tests will be used for within-group pre-test and post-test comparisons
Participants The study will include 22 healthy women with flexible flatfoot who have no congenital deformities or diseases of the feet knees and have a navicular drop of 10 mm The participants will be recruited from Clinical Pilates studio in Busan city Women with bilateral flatfoot n22 will be randomly allocated to either the Pilates training group PTG n11 or the non-training group NTG n11
Outcome measure gait assessment and data acquisition Participants undergo several practice walks to familiarize themselves with the gait assessment Three records are averaged once they show a normal gait pattern The assessment uses measurements from both legs and is conducted in a non-distracting environment
Seven 3D infrared motion capture cameras Vicon camera MX-T20 Oxford Metrics Oxford UK and 16 circular reflective markers 14-mm diameter are used to acquire the data for the gait assessment The reflective markers are attached to the anterior superior iliac spine posterior superior iliac spine lateral mid-thigh lateral femoral epicondyle mid-shin lateral malleolus second metatarsus and heel of both the left and right legs The height body weight and width of knee and ankle joints are measured and entered Gait analysis includes temporal parameters such as foot-off step time stride time walking speed and cadence Kinematic data are collected using Vicon plug-in gait system Oxford Metrics at a sampling frequency of 100 Hz
balance assessment and data acquisition The participants are instructed to stand with their arms crossed in front of their chest with one leg supported and one leg raised with the knee at a 90 angle Participants hold that standing position for 40 seconds Three successful attempts are recorded for each participant Measurements are taken for both legs and the participants are given sufficient time to rest between each stage of the experiment
For Center of Pressure COP measurement data from 40 seconds of single leg support on a force platform AMTI-OR6 Watertown MA USA are utilized The data are calculated and assessed as time series data COP sway variability is assessed based on the Root Mean Sqaure RMS in Anterior-Posterior AP and Medial-Lateral ML directions while AP and ML components of COP velocity and range are also assessed Kinematic data are collected using the Vicon Plug-in Gait system at a sampling frequency of 100 Hz
Exercise intervention
The exercise intervention consists of two sessions each week for a total of 16 sessions over an 8-week period Each training session is structured into eight sets totaling 50 minites This includes a 5-min warm-up period followed by 40-min of the main exercise component and concluding with a 5-min cool-down phase The Pilates training is supervised by an instructor with 15 years of experience and a professional Pilates certification
Statistical analysis IBM SPSS Statistics for Windows version 280 IBM Corp Armonk NY USA is used to conduct descriptive statistical analyses including means and standard deviations Statistical significance is set at p005
Differences in mean values between the groups for each temporal parameter will be assessed using independent samples t-tests Additionally due to the small sample size non-parametric tests Mann-Whitney U test will be conducted Furthermore paired samples t-tests will be used for within-group pre-test and post-test comparisons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None