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

Primary Purpose

Pes Planus

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Release
Kinesio Taping
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring Pes planus, Kinesio Taping, Manual release, Plantar fascia

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual release group

Kinesio taping group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 7, 2022
Last Updated
April 6, 2022
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05296850
Brief Title
Immediate Effects of Kinesio Taping and Manual Release in Young Adults With Pes Planus
Official Title
Investigation of the Immediate Effects of Kinesio Taping and Manual Release on Lower Extremity Performance in Young Adults With Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
April 16, 2022 (Anticipated)
Study Completion Date
April 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
Pes planus, Kinesio Taping, Manual release, Plantar fascia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual release group
Arm Type
Experimental
Arm Description
Manual release will perform with plantar fascia and flexor hallucis longus stretching and tissue mobilization. Stretching/mobilization will applied for approximately 3 minutes.
Arm Title
Kinesio taping group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Release
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed up and go test (TUG)
Description
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.
Time Frame
Change from baseline at immediately after one-session treatment
Secondary Outcome Measure Information:
Title
Heel rise test (HRT)
Description
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.
Time Frame
Change from baseline at immediately after one-session treatment
Title
10 meter walk test, walking speed
Description
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.
Time Frame
Change from baseline at immediately after one-session treatment
Title
10 meter walk test, cadence
Description
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.
Time Frame
Change from baseline at immediately after one-session treatment
Title
Functional reach test (FUT)
Description
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.
Time Frame
Change from baseline at immediately after one-session treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba Ulusoy, PT
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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
Results Reference
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31590069
Citation
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Results Reference
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PubMed Identifier
30270752
Citation
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.
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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. Erratum In: J Orthop. 2020 Dec 15;24:293.
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Immediate Effects of Kinesio Taping and Manual Release in Young Adults With Pes Planus

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