Skip to main content
OpenTrials
Completed

NCT Number: NCT06583434

Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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 (n=22) will be randomly allocated to either the Pilates training group (PTG, n=11) or the non-training group (NTG, n=11).

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 28.0; IBM Corp., Armonk, N.Y., USA) is used to conduct descriptive statistical analyses, including means and standard deviations. Statistical significance is set at p<0.05.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral navicular drop of ≥10 mm

Exclusion criteria

  • Clinical diagnosis of Alzheimer's Disease
  • Severe heart conditions (heart failure, myocardial infarction)
  • History of knee, ankle or hip injuries within the last 3 months
  • Chronic lung disease
  • Pregnancy
  • Congenital Foot Deformity ( Polydactyly, Syndactyly)

Treatment and study plan

core-lower extremity Pilates Training Group

Behavioral

Participants in this group will engage in a stabilization-based Pilates exercise program focusing on core and lower extremity stabilization. The program consists of twice-weekly sessions, each lasting 50 minutes, over a period of 8 weeks. The primary goal of the intervention is to improve gait patterns and balance in women with flexible pes planus

Non-Training Group

Other

Participants in this group will not receive any specific intervention during the study period. They will continue their usual activities without any additional exercises provided by the study.

Primary outcomes

  1. Change in step time

    Time frame: Baseline and after 8 weeks

    Step time was measured in seconds using a 3D motion capture system.

  2. Change in stride time

    Time frame: Baseline and after 8 weeks

    Stride time was measured in seconds using a 3D motion capture system.

  3. Change in walking speed

    Time frame: Baseline and after 8 weeks

    Walking speed was measured in meters per second using a 3D motion capture system.

  4. Change in cadence

    Time frame: Baseline and after 8 weeks

    Cadence was measured in steps per minute using a 3D motion capture system.

  5. Change in foot off

    Time frame: Baseline and after 8 weeks

    Foot off was measured as a percentage of the gate cycle using a 3D motion capture system.

  6. Change in balance stability

    Time frame: Baseline and after 8 weeks

    Balance was assessed using a single-leg stance test, measuring the center of pressure(COP) sway in both anterior-posterior (AP) and medial-lateral (ML) directions.

Sponsors and collaborators

Lead sponsor

Hyun Ju Kim

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 4, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.