NCT05296850

Brief Summary

Pes planus is a postural deformity seen with decreased medial longitudinal arch (MLA) height and this causes intense stress on the plantar fascia. Pes planus may affect individuals' activities of daily living, their productivity in occupational environments, and the risk of injury and performance in sports; It has also been reported that it may cause different musculoskeletal diseases such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain in the future. Many clinical methods are used as a treatment for pes planus and most treatments involve supporting an overstretched plantar fascia and weakened MLA. The aim of the study is to investigate the immediate effects of kinesio taping and manual release on lower extremity performance in young adults with pes planus.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 16, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2022

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 7, 2022

Last Update Submit

April 6, 2022

Conditions

Keywords

Pes planusKinesio TapingManual releasePlantar fascia

Outcome Measures

Primary Outcomes (1)

  • Timed up and go test (TUG)

    The timed up and go test is used to assess functional mobility. The test involves getting up from a standard chair without armrests, walking around a cone 3 m in front of the chair, and returning to the original sitting position as quickly as possible without running. The test is started with the researcher's verbal "go" instruction and the time to complete the test is recorded. After a familiarization attempt, three recorded exercises are performed with one-minute rest intervals. The fastest of three attempts is saved.

    Change from baseline at immediately after one-session treatment

Secondary Outcomes (4)

  • Heel rise test (HRT)

    Change from baseline at immediately after one-session treatment

  • 10 meter walk test, walking speed

    Change from baseline at immediately after one-session treatment

  • 10 meter walk test, cadence

    Change from baseline at immediately after one-session treatment

  • Functional reach test (FUT)

    Change from baseline at immediately after one-session treatment

Study Arms (2)

Manual release group

EXPERIMENTAL

Manual release will perform with plantar fascia and flexor hallucis longus stretching and tissue mobilization. Stretching/mobilization will applied for approximately 3 minutes.

Other: Manual Release

Kinesio taping group

EXPERIMENTAL

Two techniques will be used in kinesio taping application; first technique is the gastrocnemius muscle inhibition technique and the plantar fascia ligament correction technique and other technique is the transverse arch ligament correction technique.

Other: Kinesio Taping

Interventions

Individuals are placed in the prone position with their knees extended. The calcaneus is kept in eversion while maintaining talocrural dorsiflexion. As the toes are stretched in dorsiflexion, the therapist slides the big toe distally and proximally along the plantar fascia and flexor hallucis longus. Soft tissue mobilization depth will be applied according to the patient's tolerance and reactivity.

Manual release group

In the first technique, an "I" tape will be applied on the plantar surface of the foot from the metatarsal heads to the popliteal fossa. First, the middle of the band is attached to the inferior of the calcaneus as the first anchor, then the ankle is dorsiflexed and the upper part of the band is applied with 15-25% tension until the popliteal fossa. The plantar fascia is placed in a stretched position by dorsiflexing the ankle and fingers, and the ends of the tape, which is divided into 4 parts, are applied separately to the metatarsal heads with 75-100% tension. In the second technique, the application is made with an "I" tape. The initial anchor starts from the dorsal aspect of the 5th metatarsal on the lateral aspect of the foot. Then, the tape passes to the medial side of the foot with 75-100% tension and is adhered to the medial side of the foot and ankle over the navicular. The end anchor is applied without tension.

Kinesio taping group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who volunteer to participate in the study
  • Individuals with bilateral pes planus
  • Individuals who have not had any ankle injury in the last 6 months

You may not qualify if:

  • Individuals with severe visual and hearing impairment
  • Individuals with congenital shortness or deformity in their lower extremities
  • Individuals who have had any lower extremity surgery
  • Individuals with hallux valgus, hallux rigidus, or calcaneal epine
  • Individuals with any musculoskeletal problem other than pes planus and systemic, neurological problems
  • Individuals with chronic ankle instability
  • Individuals who have had problems walking for the last 6 months
  • Individuals who have received treatment for pes planus in the last 6 months and use insoles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Publications (12)

  • Govind, S., Singh, K., Mahalingam, K. ve SREE Vamsi, G. To Compare the Effectiveness of Taping and Arch Support on the Flexible Flat Foot on a Random Population. Indian Journal of Forensic Medicine and Toxicology. 2020

    BACKGROUND
  • Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29.

    PMID: 31590069BACKGROUND
  • Tas S, Unluer NO, Korkusuz F. Morphological and mechanical properties of plantar fascia and intrinsic foot muscles in individuals with and without flat foot. J Orthop Surg (Hong Kong). 2018 May-Aug;26(3):2309499018802482. doi: 10.1177/2309499018802482.

    PMID: 30270752BACKGROUND
  • Angin S, Mickle KJ, Nester CJ. Contributions of foot muscles and plantar fascia morphology to foot posture. Gait Posture. 2018 Mar;61:238-242. doi: 10.1016/j.gaitpost.2018.01.022. Epub 2018 Mar 20.

    PMID: 29413791BACKGROUND
  • Filardi V. Flatfoot and normal foot a comparative analysis of the stress shielding. J Orthop. 2018 Aug 16;15(3):820-825. doi: 10.1016/j.jor.2018.08.002. eCollection 2018 Sep.

    PMID: 30140126BACKGROUND
  • Wang JS, Um GM, Choi JH. Immediate effects of kinematic taping on lower extremity muscle tone and stiffness in flexible flat feet. J Phys Ther Sci. 2016 Apr;28(4):1339-42. doi: 10.1589/jpts.28.1339. Epub 2016 Apr 28.

    PMID: 27190479BACKGROUND
  • Montgomery G, McPhee J, Paasuke M, Sipila S, Maier AB, Hogrel JY, Degens H. Determinants of Performance in the Timed Up-and-Go and Six-Minute Walk Tests in Young and Old Healthy Adults. J Clin Med. 2020 May 21;9(5):1561. doi: 10.3390/jcm9051561.

    PMID: 32455757BACKGROUND
  • Gunay S, Karaduman A, Ozturk BB. Effects of Aircast brace and elastic bandage on physical performance of athletes after ankle injuries. Acta Orthop Traumatol Turc. 2014;48(1):10-6. doi: 10.3944/AOTT.2014.2981.

    PMID: 24643094BACKGROUND
  • Soulard J, Vaillant J, Balaguier R, Vuillerme N. Spatio-temporal gait parameters obtained from foot-worn inertial sensors are reliable in healthy adults in single- and dual-task conditions. Sci Rep. 2021 May 13;11(1):10229. doi: 10.1038/s41598-021-88794-4.

    PMID: 33986307BACKGROUND
  • Tedla JS, Asiri F, Alshahrani MS, Sangadala DR, Gular K, Rengaramanujam K, Mukherjee D. Reference Values of Functional and Lateral Reach Test Among the Young Saudi Population: Their Psychometric Properties and Correlation with Anthropometric Parameters. Med Sci Monit. 2019 Jul 31;25:5683-5689. doi: 10.12659/MSM.916443.

    PMID: 31365521BACKGROUND
  • Baltacı, G. Bantlama. (N. Ozunlu Pekyavas, Ed.). Ankara: Hipokrat Yayıncılık.2020; 194-195

    BACKGROUND
  • Cleland JA, Abbott JH, Kidd MO, Stockwell S, Cheney S, Gerrard DF, Flynn TW. Manual physical therapy and exercise versus electrophysical agents and exercise in the management of plantar heel pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2009 Aug;39(8):573-85. doi: 10.2519/jospt.2009.3036.

    PMID: 19687575BACKGROUND

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

  • Tuğba Ulusoy, PT

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Ertuğrul Demirdel, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial: Two parallel treatment groups; participants were randomly allocated to Group 1 \[Manual release (MR)\] and Group 2 \[Kinesio taping (KT)\]
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 25, 2022

Study Start

February 16, 2022

Primary Completion

April 16, 2022

Study Completion

April 16, 2022

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations