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Effect of Myofascial Release in Addition to Foot Core Exercises in Young Adults With Asymptomatic Flexible Pes Planus

Primary Purpose

Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foam Roller
Foot Core Exercises
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, Foot Core Exercises, Myofascial Release, Foam Rolling

Eligibility Criteria

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

Inclusion Criteria: Be between the ages of 18-25, Bilateral navicular drop distance of 10 mm or more, Bilateral asymptomatic flexible pes planus, Volunteering to participate in the study and being able to continue. Exclusion Criteria: Musculoskeletal disorders other than pes planus, Having chronic ankle instability, Any lower extremity injury in the last 6 months, Receiving a treatment related to pes planus in the last 6 months, Use of 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

Foam Roller+Foot Core Exercises Group

Foot Core Exercises Group

Arm Description

Participants in the foam roller+exercise group underwent foam roller application, which is a self-myofascial release method, 2 days a week for 6 weeks in addition to exercises. Medium-hard foam rollers were used in the applications. Foam roller application was performed on thoracolumbar fascia, iliotibial band, hamstring, gastro-soleus, peroneals and plantar fascia for 60 seconds on each region. A metronome was used to determine the rhythm during foam roller application. The rhythm of the metronome was set to 60 beats per minute (60 rpm). When determining the amount of load on the tissue, the participants were told to give the maximum amount of load possible.

The foot core exercises in the treatment program for young adults with pes planus were taught to the participants one by one. It was checked that each exercise in the program was performed correctly by the participants. An exercise brochure was prepared and given to all participants so that the participants could learn the exercises better and perform them correctly. The exercise program follow-up of the participants and gradual progression of the difficulty levels were performed by the responsible researcher. The exercises were performed two days a week for six weeks under the supervision of the researcher. On the other days, the exercise program follow-up was checked daily via an online platform.

Outcomes

Primary Outcome Measures

Change in Balance
The Y balance test is used for balance assessment. A "Y" shaped design is made using three tape measures placed on the ground. After the first tape measure is placed in the anterior (ant) direction, the other two tape measures are placed on the ground in the posteromedial (pm) and posterolateral (pl) directions to form a 135-degree angle. How the test will be performed is clearly explained to the individuals before the test and they are allowed to perform three trials. With the hands on the waist, the fingertip reach in each of the three directions is recorded in centimeters (cm). The maximum distance they can reach in three reaches in each direction is recorded. This process is also repeated while standing on the other limb and recorded. Lower limb length is calculated by measuring the distance between the spina iliaca anterior superior and the medial malleolus with a tape measure. With the results obtained, the normalized reach and the composite reach for both limbs are calculated.

Secondary Outcome Measures

Change in Flexibility
Flexibility is assessed with the sit and reach test. Individuals are trained on how to perform the sit and reach test using three warm-up trials. All individuals sit with the heels/soles of their feet resting on the box, knees fully extended, and fingertips extended as far as possible in the correct position on the metal slide. Individuals are instructed to reach as far forward as possible by pushing the measurement indicator with their fingertips and to hold the maximum reach for two seconds. Three measurements are recorded and the mean calculated.
Change in Power
Power will be evaluated by vertical jump test. Individuals are measured in a fully rested state and 3 repetitions of vertical jump with 45 seconds rest interval, the best score is recorded.
Change in Gait
Gait is assessed with the 10-meter walk test. The test is performed at a comfortable walking speed on a 14 m walkway for 10 m walk, start (2 m) and finish (2 m). Measurements are repeated 3 times and the average time is recorded in seconds. Cadence is calculated and recorded during the test.

Full Information

First Posted
March 4, 2023
Last Updated
October 9, 2023
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05774327
Brief Title
Effect of Myofascial Release in Addition to Foot Core Exercises in Young Adults With Asymptomatic Flexible Pes Planus
Official Title
The Effect of Myofascial Release in Addition to Foot Core Exercises on Lower Extremity Performance in Young Adults With Asymptomatic Flexible Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
May 26, 2023 (Actual)
Study Completion Date
June 9, 2023 (Actual)

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 foot deformity characterized by a low medial longitudinal arch. It is more common in young adults. With low arch, tension occurs in the plantar fascia. Fascia and soft tissue loading may lead to different musculoskeletal problems such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain. In addition, pes planus can affect individuals' activities of daily living, productivity in occupational settings, and injury risk and performance in sports. Treatment of pes planus includes strengthening, stretching, taping and orthotics for the foot muscles. Among these applications, strengthening of the foot core muscles is one of the most common and effective methods. By strengthening the foot core muscles, it is aimed to reduce the effect of the kinetic chain. Pes planus is a postural deformity that affects the kinetic and fascial chain, but the treatment program is usually planned regionally. With fascial continuity and fascial conduction, the tension on the plantar fascia in pes planus affects the gastro-soleus, peroneus longus and brevis, hamstring muscles, iliotibial band and thoracolumbar fascia. Stretching of the plantar fascia, which is included in current treatment programs, has only a local effect and thus cannot prevent fascial chain involvement. Myofascial release, one of the methods used to reduce the tension in the fascia, has been used frequently in recent years. Myofascial release is performed with methods such as manual, foam roller and instrument assisted release. Foam roller (cylinder foam) is a practical myofascial release method that can be self-applied by the individual. In addition to strengthening the intrinsic muscles of the foot in individuals with pes planus, it has been reported that fascial chain involvement should also be taken into consideration due to the tension in the plantar fascia with low arch. This study was planned to investigate the effect of myofascial release methods on lower extremity performance in addition to foot core exercises used effectively in the treatment of pes planus.
Detailed Description
This study will be carried out with a Randomized Controlled Prospective Study design. For this study, individuals between the ages of 18-25 years with a fall amount of 10 millimeters or more according to the navicular fall test and flexible pes planus according to Jack's finger lift test will be informed about the study and consent for participation will be obtained. Demographic information of the individuals who accept participation will be collected. This study, 2 randomized groups of young adults with flexible pes planus will be formed and one group will be applied an exercise program including only foot core exercises, while the other group will be applied self myofascial release with foam rollers, which is a myofascial release method, in addition to foot core exercises. Both the experimental and control groups will receive a program consisting of 7 different foot core exercises, each of which will be progressed gradually for 6 weeks, 3 sets of 10 repetitions per day. A brochure for the exercises will be prepared and given to the participants to do at home. In order to follow up the exercise of the participants, the individuals will be called weekly during this period and exercise follow-up will be performed. The experimental group will also be planned to perform 60 seconds of myofascial release on each tissue on the thoracolumbar fascia, iliotibial band, hamstring, gastro-soleus, peroneals and plantar fascia 2 days a week for 6 weeks with foam roller, which is a self-myofascial release method. The amount of load on the tissue will be determined by instructing the individuals to apply the maximum amount of load possible. At the end of six weeks, the initial evaluations will be performed again on all individuals and the measurement results will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
Pes Planus, Foot Core Exercises, Myofascial Release, Foam Rolling

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 [Foam Roller+Foot Core Exercises] and Group 2 [Foot Core Exercises]
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foam Roller+Foot Core Exercises Group
Arm Type
Experimental
Arm Description
Participants in the foam roller+exercise group underwent foam roller application, which is a self-myofascial release method, 2 days a week for 6 weeks in addition to exercises. Medium-hard foam rollers were used in the applications. Foam roller application was performed on thoracolumbar fascia, iliotibial band, hamstring, gastro-soleus, peroneals and plantar fascia for 60 seconds on each region. A metronome was used to determine the rhythm during foam roller application. The rhythm of the metronome was set to 60 beats per minute (60 rpm). When determining the amount of load on the tissue, the participants were told to give the maximum amount of load possible.
Arm Title
Foot Core Exercises Group
Arm Type
Experimental
Arm Description
The foot core exercises in the treatment program for young adults with pes planus were taught to the participants one by one. It was checked that each exercise in the program was performed correctly by the participants. An exercise brochure was prepared and given to all participants so that the participants could learn the exercises better and perform them correctly. The exercise program follow-up of the participants and gradual progression of the difficulty levels were performed by the responsible researcher. The exercises were performed two days a week for six weeks under the supervision of the researcher. On the other days, the exercise program follow-up was checked daily via an online platform.
Intervention Type
Other
Intervention Name(s)
Foam Roller
Other Intervention Name(s)
Foot Core Exercises
Intervention Description
Participants will be shown 7 different foot core exercises and will be instructed to do 10 repetitions 3 times a day. For 6 weeks, in addition to foot core exercises, myofascial release will be applied with foam roller 2 days a week. Myofascial release application areas; thoracolumbal fascia, iliotibial band, hamstring, gastro-soleus, peroneal, plantar fascia.
Intervention Type
Other
Intervention Name(s)
Foot Core Exercises
Intervention Description
Participants will be shown 7 different foot core exercises and will be instructed to do 10 repetitions 3 times a day. Foot core exercises; short foot exercise, toe flexion exercise, heel lift exercise,toe abduction exercise, big toe and other toes extension exercise, front swing exercise, back walking exercises. Participants will do the exercises with the researcher two days a week and the other days follow-up will be provided through the online platform.
Primary Outcome Measure Information:
Title
Change in Balance
Description
The Y balance test is used for balance assessment. A "Y" shaped design is made using three tape measures placed on the ground. After the first tape measure is placed in the anterior (ant) direction, the other two tape measures are placed on the ground in the posteromedial (pm) and posterolateral (pl) directions to form a 135-degree angle. How the test will be performed is clearly explained to the individuals before the test and they are allowed to perform three trials. With the hands on the waist, the fingertip reach in each of the three directions is recorded in centimeters (cm). The maximum distance they can reach in three reaches in each direction is recorded. This process is also repeated while standing on the other limb and recorded. Lower limb length is calculated by measuring the distance between the spina iliaca anterior superior and the medial malleolus with a tape measure. With the results obtained, the normalized reach and the composite reach for both limbs are calculated.
Time Frame
Change from Baseline Y Balance Test Results at 6 weeks.
Secondary Outcome Measure Information:
Title
Change in Flexibility
Description
Flexibility is assessed with the sit and reach test. Individuals are trained on how to perform the sit and reach test using three warm-up trials. All individuals sit with the heels/soles of their feet resting on the box, knees fully extended, and fingertips extended as far as possible in the correct position on the metal slide. Individuals are instructed to reach as far forward as possible by pushing the measurement indicator with their fingertips and to hold the maximum reach for two seconds. Three measurements are recorded and the mean calculated.
Time Frame
Change from Baseline Sit and Reach Test Results at 6 weeks.
Title
Change in Power
Description
Power will be evaluated by vertical jump test. Individuals are measured in a fully rested state and 3 repetitions of vertical jump with 45 seconds rest interval, the best score is recorded.
Time Frame
Change from Baseline Vertical Jump Test Results at 6 weeks.
Title
Change in Gait
Description
Gait is assessed with the 10-meter walk test. The test is performed at a comfortable walking speed on a 14 m walkway for 10 m walk, start (2 m) and finish (2 m). Measurements are repeated 3 times and the average time is recorded in seconds. Cadence is calculated and recorded during the test.
Time Frame
Change from Baseline 10-Meter Walk Test Results at 6 weeks.

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: Be between the ages of 18-25, Bilateral navicular drop distance of 10 mm or more, Bilateral asymptomatic flexible pes planus, Volunteering to participate in the study and being able to continue. Exclusion Criteria: Musculoskeletal disorders other than pes planus, Having chronic ankle instability, Any lower extremity injury in the last 6 months, Receiving a treatment related to pes planus in the last 6 months, Use of insoles.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba Ulusoy, PT, MSc
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, Assoc.prof.
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:
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Effect of Myofascial Release in Addition to Foot Core Exercises in Young Adults With Asymptomatic Flexible Pes Planus

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