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Pes PlanusNCT05296850

Immediate Effects of Kinesio Taping and Manual Release in Young Adults With Pes Planus

A study testing Manual Release and Kinesio Taping in people with Pes Planus, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Pes Planus
What is being tested?
Manual Release and Kinesio Taping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Feb 2022to 16 Apr 2022
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 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Immediate Effects of Kinesio Taping and Manual Release on Lower Extremity Performance in Young Adults With Pes Planus

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.

Read the detailed description

This study is a randomized controlled trial, will be carried out on volunteer individuals with pes planus aged between 18-25, studying at Ankara Yıldırım Beyazıt University. Evaluation of parameters and inclusion criteria, kinesio taping and manual release applications will be made by the Physiotherapist. Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, Group 1 [Manual Release (MR)] and Group 2 [Kinesio Taping (KT)]. A simple randomization method will be used with opaque sealed envelopes containing "1" or "2". Group allocation will be performed by an independent therapist, not involved in the study. All individuals will be evaluated with timed up-and-go test, heel rise test, 10-meter walking test, and functional reach test before and after the intervention. Manual release will be applied to group 1 after the evaluation and the evaluations will be repeated immediately the end of the application. Kinesio taping will be applied to group 2 after the evaluation and the evaluations will be repeated 45 minutes after the end of the application.

Conditions
Pes Planus
Being tested
Manual Release, Kinesio Taping
Keywords
Pes planus, Kinesio Taping, Manual release, Plantar fascia
Medical subject headings
Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual ReleaseOther

    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.

  • Kinesio TapingOther

    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.

Study groups in NCT05296850
Study groupRoleWhat they receive
Manual release groupExperimentalManual release will perform with plantar fascia and flexor hallucis longus stretching and tissue mobilization. Stretching/mobilization will applied for approximately 3 minutes.
Receives: Other: Manual Release
Kinesio taping groupExperimentalTwo 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.
Receives: Other: Kinesio Taping

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline at immediately after one-session treatment

Secondary outcomes (4)
  1. Heel rise test (HRT)

    The endurance of the gastro-soleus muscle complex is evaluated with the heel rise test. The number of toe-ups in one minute is determined when the knees of the subjects are in extension. The results are recorded as the number of repetitions.

    Measured: Change from baseline at immediately after one-session treatment

  2. 10 meter walk test, walking speed

    Walking speed is evaluated with the 10 meter walking test. The test is performed at a comfortable walking pace on a 10 m walk, 14 m walkway for the start (2 m) and finish (2 m). Measurements are repeated 3 times and the average time is recorded in seconds.

    Measured: Change from baseline at immediately after one-session treatment

  3. 10 meter walk test, cadence

    Cadence is evaluated with the 10 meter walking test. The test is performed at a comfortable walking pace on a 10 m walk, 14 m walkway for the start (2 m) and finish (2 m). During the 10-meter walk, the number of steps is recorded.

    Measured: Change from baseline at immediately after one-session treatment

  4. Functional reach test (FUT)

    Balance is assessed with the functional reach test. In the application of the test, the individual is asked to keep his feet open and close to a parallel shoulder-width wall. The individual have a measuring stick attached to the wall at shoulder level. The individual is asked to punch his hand and flex his shoulder 90 degrees without touching the wall, and bring the third metacarpal finger joint of his hand to the starting point of the measuring stick.The individual is guided to reach as far as possible without taking a step, without lifting his heels, without bending his knees, and the end point is recorded. The difference between the starting position and the ending position is measured in cm. The test is repeated three times and the average of the three measurements is recorded.

    Measured: Change from baseline at immediately after one-session treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start16 Feb 2022
  3. Primary completion16 Apr 2022 (estimated)
  4. Study completion16 Apr 2022 (estimated)

Resources

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
Model description
A randomized controlled trial: Two parallel treatment groups; participants were randomly allocated to Group 1 \[Manual release (MR)\] and Group 2 \[Kinesio taping (KT)\]
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05296850
Sponsor's protocol ID
2021-512
Status last verified
Apr 2022
First submitted
7 Mar 2022
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 31590069
  • 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.

    PubMed 30270752
  • 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.

    PubMed 29413791
  • 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.

    PubMed 30140126
  • 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.

    PubMed 27190479
  • 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.

    PubMed 32455757
  • 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.

    PubMed 24643094
  • 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.

    PubMed 33986307
  • 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.

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

  • 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.

    PubMed 19687575

Questions about this trial

What is this clinical trial studying?

A study testing Manual Release and Kinesio Taping in people with Pes Planus, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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 Turkey (Türkiye). 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?

Results are not available in the source record.

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?

Timed up and go test (TUG) (time frame: Change from baseline at immediately after one-session treatment). 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 NCT05296850, which also lists 12 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 7 Apr 2022.

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