Flexible FlatfootNCT06583434
Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus
A study testing core-lower extremity Pilates Training Group and Non-Training Group in people with Flexible Flatfoot, run by Hyun Ju Kim at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- core-lower extremity Pilates Training Group and Non-Training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2024to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral navicular drop of ≥10 mm
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 (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.
- Conditions
- Flexible Flatfoot
- Being tested
- core-lower extremity Pilates Training Group, Non-Training Group
- Keywords
- flexible flatfoot, balance, gait, Pilates, pesplanus
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core-lower extremity Pilates Training GroupBehavioural
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates-Training Group | Experimental | Participants in this group will receive twice-weekly Pilates sessions focusing on core and lower extremity stabilization exercises. Each session will last for 50 minutes and the intervention will continue for 8 weeks. The goal of this intervention is to improve gait patterns and balance in women with flexible flatfoot. Receives: Behavioral: core-lower extremity Pilates Training Group |
| Non-Training Group | Experimental | 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 Receives: Other: Non-Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in step time
Step time was measured in seconds using a 3D motion capture system.
Measured: Baseline and after 8 weeks
Change in stride time
Stride time was measured in seconds using a 3D motion capture system.
Measured: Baseline and after 8 weeks
Change in walking speed
Walking speed was measured in meters per second using a 3D motion capture system.
Measured: Baseline and after 8 weeks
Change in cadence
Cadence was measured in steps per minute using a 3D motion capture system.
Measured: Baseline and after 8 weeks
Change in foot off
Foot off was measured as a percentage of the gate cycle using a 3D motion capture system.
Measured: Baseline and after 8 weeks
Change in balance stability
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.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start2 Jan 2024
- Primary completion8 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyun Ju Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyun Ju Kim, Busan University of Foreign Studies
- Investigators
- Hyun Ju Kim, MSc, Principal investigator, Department of Sports and Health Convergence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583434
- Sponsor's protocol ID
- BUFS-FF-2023
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared via Figshare. The data will include demographic information, raw data from the assessments, and any other relevant data collected during the study.
Publications
Abasiyanik Z, Ertekin O, Kahraman T, Yigit P, Ozakbas S. The effects of Clinical Pilates training on walking, balance, fall risk, respiratory, and cognitive functions in persons with multiple sclerosis: A randomized controlled trial. Explore (NY). 2020 Jan-Feb;16(1):12-20. doi: 10.1016/j.explore.2019.07.010. Epub 2019 Jul 17.
PubMed 31377306Behm DG, Muehlbauer T, Kibele A, Granacher U. Effects of Strength Training Using Unstable Surfaces on Strength, Power and Balance Performance Across the Lifespan: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1645-69. doi: 10.1007/s40279-015-0384-x.
PubMed 26359066Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.
PubMed 21975148Buldt AK, Levinger P, Murley GS, Menz HB, Nester CJ, Landorf KB. Foot posture is associated with kinematics of the foot during gait: A comparison of normal, planus and cavus feet. Gait Posture. 2015 Jun;42(1):42-8. doi: 10.1016/j.gaitpost.2015.03.004. Epub 2015 Mar 12.
PubMed 25819716Bullo V, Bergamin M, Gobbo S, Sieverdes JC, Zaccaria M, Neunhaeuserer D, Ermolao A. The effects of Pilates exercise training on physical fitness and wellbeing in the elderly: A systematic review for future exercise prescription. Prev Med. 2015 Jun;75:1-11. doi: 10.1016/j.ypmed.2015.03.002. Epub 2015 Mar 12.
PubMed 25773473Caravaggi P, Pataky T, Gunther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.
PubMed 20646107Casonatto J, Yamacita CM. Pilates exercise and postural balance in older adults: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2020 Jan;48:102232. doi: 10.1016/j.ctim.2019.102232. Epub 2019 Nov 3.
PubMed 31987246Cote KP, Brunet ME, Gansneder BM, Shultz SJ. Effects of Pronated and Supinated Foot Postures on Static and Dynamic Postural Stability. J Athl Train. 2005 Mar;40(1):41-46.
PubMed 15902323Dingenen B, Malfait B, Nijs S, Peers KH, Vereecken S, Verschueren SM, Janssens L, Staes FF. Postural Stability During Single-Leg Stance: A Preliminary Evaluation of Noncontact Lower Extremity Injury Risk. J Orthop Sports Phys Ther. 2016 Aug;46(8):650-7. doi: 10.2519/jospt.2016.6278. Epub 2016 Jul 3.
PubMed 27374015Dlugosz-Bos M, Filar-Mierzwa K, Stawarz R, Scislowska-Czarnecka A, Jankowicz-Szymanska A, Bac A. Effect of Three Months Pilates Training on Balance and Fall Risk in Older Women. Int J Environ Res Public Health. 2021 Apr 1;18(7):3663. doi: 10.3390/ijerph18073663.
PubMed 33915843Domjanic J, Fieder M, Seidler H, Mitteroecker P. Geometric morphometric footprint analysis of young women. J Foot Ankle Res. 2013 Jul 25;6(1):27. doi: 10.1186/1757-1146-6-27.
PubMed 23886074Donatoni da Silva L, Shiel A, Sheahan J, McIntosh C. Six weeks of Pilates improved functional mobility, postural balance and spatiotemporal parameters of gait to decrease the risk of falls in healthy older adults. J Bodyw Mov Ther. 2022 Jan;29:1-9. doi: 10.1016/j.jbmt.2021.06.014. Epub 2021 Jun 23.
PubMed 35248255Ekstrom RA, Donatelli RA, Carp KC. Electromyographic analysis of core trunk, hip, and thigh muscles during 9 rehabilitation exercises. J Orthop Sports Phys Ther. 2007 Dec;37(12):754-62. doi: 10.2519/jospt.2007.2471. Epub 2007 Aug 29.
PubMed 18560185Elsayed W, Alotaibi S, Shaheen A, Farouk M, Farrag A. The combined effect of short foot exercises and orthosis in symptomatic flexible flatfoot: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Jun;59(3):396-405. doi: 10.23736/S1973-9087.23.07846-2. Epub 2023 Mar 29.
PubMed 36988565Farokhmanesh K, Shirzadian T, Mahboubi M, Shahri MN. Effect of foot hyperpronation on lumbar lordosis and thoracic kyphosis in standing position using 3-dimensional ultrasound-based motion analysis system. Glob J Health Sci. 2014 Jun 17;6(5):254-60. doi: 10.5539/gjhs.v6n5p254.
PubMed 25169004
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stabilization-based Pilates Exercise on Gait and Balance in Women With Flexible Pesplanus
- ClinicalTrials.gov ID
- NCT06583434
- Acronym / sponsor ID
- BUFS-FF-2023
- Conditions
- Flexible Flatfoot
- Keywords
- flexible flatfoot, balance, gait, Pilates, pesplanus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hyun Ju KimUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates-Training Group | Experimental | Behavioral: core-lower extremity Pilates Training GroupParticipants in this group will receive twice-weekly Pilates sessions focusing on core and lower extremity stabilization exercises. Each session will last for 50 minutes and the intervention will continue for 8 weeks. The goal of this intervention is to improve gait patterns and balance in women with flexible flatfoot. |
| Non-Training Group | Experimental | Other: Non-Training GroupParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bilateral navicular drop of ≥10 mm
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core-lower extremity Pilates Training GroupParticipants 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 | Behavioural | Pilates-Training Group |
| Non-Training GroupParticipants 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. | Other | Non-Training Group |
Primary outcome
Change in step time
Time frame: Baseline and after 8 weeks
Step time was measured in seconds using a 3D motion capture system.
Change in stride time
Time frame: Baseline and after 8 weeks
Stride time was measured in seconds using a 3D motion capture system.
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.
Change in cadence
Time frame: Baseline and after 8 weeks
Cadence was measured in steps per minute using a 3D motion capture system.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31377306Abasiyanik Z, Ertekin O, Kahraman T, Yigit P, Ozakbas S. The effects of Clinical Pilates training on walking, balance, fall risk, respiratory, and cognitive functions in persons with multiple sclerosis: A randomized controlled trial. Explore (NY). 2020 Jan-Feb;16(1):12-20. doi: 10.1016/j.explore.2019.07.010. Epub 2019 Jul 17.
- Background: PubMed 26359066Behm DG, Muehlbauer T, Kibele A, Granacher U. Effects of Strength Training Using Unstable Surfaces on Strength, Power and Balance Performance Across the Lifespan: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1645-69. doi: 10.1007/s40279-015-0384-x.
- Background: PubMed 21975148Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.
- Background: PubMed 25819716Buldt AK, Levinger P, Murley GS, Menz HB, Nester CJ, Landorf KB. Foot posture is associated with kinematics of the foot during gait: A comparison of normal, planus and cavus feet. Gait Posture. 2015 Jun;42(1):42-8. doi: 10.1016/j.gaitpost.2015.03.004. Epub 2015 Mar 12.
- Background: PubMed 25773473Bullo V, Bergamin M, Gobbo S, Sieverdes JC, Zaccaria M, Neunhaeuserer D, Ermolao A. The effects of Pilates exercise training on physical fitness and wellbeing in the elderly: A systematic review for future exercise prescription. Prev Med. 2015 Jun;75:1-11. doi: 10.1016/j.ypmed.2015.03.002. Epub 2015 Mar 12.
- Background: PubMed 20646107Caravaggi P, Pataky T, Gunther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.
- Background: PubMed 31987246Casonatto J, Yamacita CM. Pilates exercise and postural balance in older adults: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2020 Jan;48:102232. doi: 10.1016/j.ctim.2019.102232. Epub 2019 Nov 3.
- Background: PubMed 15902323Cote KP, Brunet ME, Gansneder BM, Shultz SJ. Effects of Pronated and Supinated Foot Postures on Static and Dynamic Postural Stability. J Athl Train. 2005 Mar;40(1):41-46.
- Background: PubMed 27374015Dingenen B, Malfait B, Nijs S, Peers KH, Vereecken S, Verschueren SM, Janssens L, Staes FF. Postural Stability During Single-Leg Stance: A Preliminary Evaluation of Noncontact Lower Extremity Injury Risk. J Orthop Sports Phys Ther. 2016 Aug;46(8):650-7. doi: 10.2519/jospt.2016.6278. Epub 2016 Jul 3.
- Background: PubMed 33915843Dlugosz-Bos M, Filar-Mierzwa K, Stawarz R, Scislowska-Czarnecka A, Jankowicz-Szymanska A, Bac A. Effect of Three Months Pilates Training on Balance and Fall Risk in Older Women. Int J Environ Res Public Health. 2021 Apr 1;18(7):3663. doi: 10.3390/ijerph18073663.
- Background: PubMed 23886074Domjanic J, Fieder M, Seidler H, Mitteroecker P. Geometric morphometric footprint analysis of young women. J Foot Ankle Res. 2013 Jul 25;6(1):27. doi: 10.1186/1757-1146-6-27.
- Background: PubMed 35248255Donatoni da Silva L, Shiel A, Sheahan J, McIntosh C. Six weeks of Pilates improved functional mobility, postural balance and spatiotemporal parameters of gait to decrease the risk of falls in healthy older adults. J Bodyw Mov Ther. 2022 Jan;29:1-9. doi: 10.1016/j.jbmt.2021.06.014. Epub 2021 Jun 23.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared via Figshare. The data will include demographic information, raw data from the assessments, and any other relevant data collected during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Ju Kim, MSc principal investigator
Department of Sports and Health Convergence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core-lower extremity Pilates Training Group and Non-Training Group in people with Flexible Flatfoot, run by Hyun Ju Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in step time (time frame: Baseline and after 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06583434, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.