NCT06583434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

August 29, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

flexible flatfootbalancegaitPilatespesplanus

Outcome Measures

Primary Outcomes (6)

  • Change in step time

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

    Baseline and after 8 weeks

  • Change in stride time

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

    Baseline and after 8 weeks

  • Change in walking speed

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

    Baseline and after 8 weeks

  • Change in cadence

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

    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.

    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.

    Baseline and after 8 weeks

Study Arms (2)

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.

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

Other: Non-Training Group

Interventions

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

Pilates-Training Group

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.

Non-Training Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral navicular drop of ≥10 mm

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Busan University of Foreign Studies

Busan, 46234, South Korea

Location

Related Publications (23)

  • 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.

    PMID: 31377306BACKGROUND
  • Behm 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.

    PMID: 26359066BACKGROUND
  • Bird 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.

    PMID: 21975148BACKGROUND
  • Buldt 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.

    PMID: 25819716BACKGROUND
  • Bullo 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.

    PMID: 25773473BACKGROUND
  • Caravaggi 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.

    PMID: 20646107BACKGROUND
  • Casonatto 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.

    PMID: 31987246BACKGROUND
  • Cote 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.

    PMID: 15902323BACKGROUND
  • Dingenen 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.

    PMID: 27374015BACKGROUND
  • Dlugosz-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.

    PMID: 33915843BACKGROUND
  • Domjanic 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.

    PMID: 23886074BACKGROUND
  • Donatoni 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.

    PMID: 35248255BACKGROUND
  • Ekstrom 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.

    PMID: 18560185BACKGROUND
  • Elsayed 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.

    PMID: 36988565BACKGROUND
  • Farokhmanesh 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.

    PMID: 25169004BACKGROUND
  • Flores DV, Mejia Gomez C, Fernandez Hernando M, Davis MA, Pathria MN. Adult Acquired Flatfoot Deformity: Anatomy, Biomechanics, Staging, and Imaging Findings. Radiographics. 2019 Sep-Oct;39(5):1437-1460. doi: 10.1148/rg.2019190046.

    PMID: 31498747BACKGROUND
  • Ghasemi MS, Koohpayehzadeh J, Kadkhodaei H, Ehsani AA. The effect of foot hyperpronation on spine alignment in standing position. Med J Islam Repub Iran. 2016 Dec 28;30:466. eCollection 2016.

    PMID: 28491841BACKGROUND
  • Giacomini MB, da Silva AM, Weber LM, Monteiro MB. The Pilates Method increases respiratory muscle strength and performance as well as abdominal muscle thickness. J Bodyw Mov Ther. 2016 Apr;20(2):258-64. doi: 10.1016/j.jbmt.2015.11.003. Epub 2015 Nov 10.

    PMID: 27210841BACKGROUND
  • Hillstrom HJ, Song J, Kraszewski AP, Hafer JF, Mootanah R, Dufour AB, Chow BS, Deland JT 3rd. Foot type biomechanics part 1: structure and function of the asymptomatic foot. Gait Posture. 2013 Mar;37(3):445-51. doi: 10.1016/j.gaitpost.2012.09.007. Epub 2012 Oct 26.

    PMID: 23107625BACKGROUND
  • Holowka NB, Lieberman DE. Rethinking the evolution of the human foot: insights from experimental research. J Exp Biol. 2018 Sep 6;221(Pt 17):jeb174425. doi: 10.1242/jeb.174425.

    PMID: 30190415BACKGROUND
  • Huang C, Chen LY, Liao YH, Masodsai K, Lin YY. Effects of the Short-Foot Exercise on Foot Alignment and Muscle Hypertrophy in Flatfoot Individuals: A Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 22;19(19):11994. doi: 10.3390/ijerph191911994.

    PMID: 36231295BACKGROUND
  • Huang TH, Chou LW, Huang CY, Wei SW, Tsai YJ, Chen YJ. H-reflex in abductor hallucis and postural performance between flexible flatfoot and normal foot. Phys Ther Sport. 2019 May;37:27-33. doi: 10.1016/j.ptsp.2019.02.004. Epub 2019 Feb 19.

    PMID: 30818085BACKGROUND
  • Ivanenko Y, Gurfinkel VS. Human Postural Control. Front Neurosci. 2018 Mar 20;12:171. doi: 10.3389/fnins.2018.00171. eCollection 2018.

    PMID: 29615859BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hyun Ju Kim, MSc

    Department of Sports and Health Convergence

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 4, 2024

Study Start

January 2, 2024

Primary Completion

March 8, 2024

Study Completion

March 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP
Time Frame
The data will be available immediately after the publication of the study results and will be accessible for at least 5 years
Access Criteria
The data will be openly available via Figshare without the need for a data access request

Locations