NCT06313125

Brief Summary

Flexible flatfoot deformity, also known as flexible pes planus, is a common pathological condition characterized by decreased medial longitudinal arch height, eversion of the calcaneus and abduction of the forefoot, especially during loading. Conservative treatments are generally considered as the first step in treatment. In conservative treatments, exercise methods are one of the most frequently used interventions. It has been reported that exercise can improve functional outcomes such as navicular drop, plantar pressure distribution, foot posture, balance, and muscle strength in adults with flexible flatfoot. Although it is known that intrinsic muscle strengthening exercises are a frequently used intervention method in foot pathologies, there is a deficiency in the literature regarding studies investigating the effect of the combination of the most basic foot intrinsic muscle strengthening exercises with different exercise interventions on targeted clinical gains. However, the effect of three-dimensional foot-ankle exercise on flat feet is unknown. Additionally, there are a limited number of studies in the literature investigating the effects of hip abductor and external rotator muscle strength training on foot posture in individuals with flat feet. The aim of this thesis study, planned in the light of this information, is to determine the effects of three-dimensional foot-ankle extension exercises and hip abductor-external rotator muscle strengthening exercise primarily on navicular drop and MLA height in individuals with flexible flat feet; Secondly, it is to examine and compare the effects of static foot posture, hip abductor/external rotator, ankle circumference and intrinsic muscle strength on the functional performance of the lower extremity (endurance, dynamic balance and single leg forward jumping performance). To our knowledge, this study will be the first randomized controlled study to examine and compare the effects of two different exercise interventions that exercise the proximal and distal regions in flatfoot rehabilitation, and the results obtained will contribute to the development of better exercise and treatment programs in this population. In individuals with flat feet, when hip abductor/external rotator strengthening exercises or 3D foot-ankle extension exercises in the PNF pattern are added to short-foot exercise, MLA structure, muscle strength and lower extremity function will be improved more, and when these exercises are combined with short-foot exercise, they are comparable to intrinsic muscle strengthening exercises alone. The investigators hypothesized that it would produce superior clinical results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

March 2, 2024

Last Update Submit

May 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medial longitudinal arch height-Navicular Drop Test

    To detect flatfoot MLA height will be evaluated by the Navicular Drop Test. According to this test result, if the MLA height is between 5-9 mm, the foot is in neutral position; If it is 4 mm or lower, the foot is in supination; If the value is 10 mm or more, a classification can be made as the foot is in pronation. This result will also be used when determining the inclusion criteria, and values of 10 mm and above will be interpreted as low arc.

    6 weeks

Secondary Outcomes (3)

  • Static foot posture-Foot Posture Index-6

    6 weeks

  • Foot structure-Photopodometric analysis

    6 weeks

  • Recording demographic and clinical information on the evaluation form

    1 week

Study Arms (3)

Foot-ankle exercise group

EXPERIMENTAL

In the foot-ankle exercise group, three-dimensional foot-ankle extension exercises will be applied in the Proprioceptive Neuromuscular Facilitation (PNF) pattern, in diagonal 1 and 2 directions and short-foot exercise.

Other: 3-dimensional foot-ankle extension exercisesOther: Short-foot exercise

Hip exercise group

ACTIVE COMPARATOR

Clam exercise will be given to this group as a hip abductor and external rotator strengthening exercise. In addition, short-foot exercise will be applied.

Other: Clam exerciseOther: Short-foot exercise

Control group

ACTIVE COMPARATOR

The control group will do only short-foot exercise.

Other: Short-foot exercise

Interventions

In three-dimensional foot-ankle extension exercises, an elastic band will be used to create resistance to the movement and the intensity/severity of the exercise will be between 13 (somewhat difficult) and 15 (difficult) according to the perceived difficulty level on the Borg scale. Exercises will begin with red (light) tape; Progression will be achieved by moving to a higher level band color \[green (medium) and blue (difficult) in that order\] every two weeks. Exercises will be performed 3 days a week (2 days supervised, 1 day at home), in 3 sets of 10 repetitions, and a 1-minute rest period will be given between sets to reduce fatigue. Short-foot exercises will be performed in 3 sets of 15 repetitions, with a 45-second rest period between sets, every day a week (2 days/week with a physiotherapist; 5 days/week at home) for 6 weeks.

Also known as: Short-foot exercise
Foot-ankle exercise group

In three-dimensional foot-ankle extension exercises and clam exercise, an elastic band will be used to create resistance to the movement and the intensity/severity of the exercise will be between 13 (somewhat difficult) and 15 (difficult) according to the perceived difficulty level on the Borg scale. Exercises will begin with red (light) tape; Progression will be achieved by moving to a higher level band color \[green (medium) and blue (difficult) in that order\] every two weeks. Exercises will be performed 3 days a week (2 days supervised, 1 day at home), in 3 sets of 10 repetitions, and a 1-minute rest period will be given between sets to reduce fatigue. Short-foot exercises will be performed in 3 sets of 15 repetitions, with a 45-second rest period between sets, every day a week (2 days/week with a physiotherapist; 5 days/week at home) for 6 weeks.

Also known as: Short-foot exercise
Hip exercise group

In clam exercise, an elastic band will be used to create resistance to the movement and the intensity/severity of the exercise will be between 13 (somewhat difficult) and 15 (difficult) according to the perceived difficulty level on the Borg scale. Exercises will begin with red (light) tape; Progression will be achieved by moving to a higher level band color \[green (medium) and blue (difficult) in that order\] every two weeks. Exercises will be performed 3 days a week (2 days supervised, 1 day at home), in 3 sets of 10 repetitions, and a 1-minute rest period will be given between sets to reduce fatigue. Short-foot exercises will be performed in 3 sets of 15 repetitions, with a 45-second rest period between sets, every day a week (2 days/week with a physiotherapist; 5 days/week at home) for 6 weeks.

Control groupFoot-ankle exercise groupHip exercise group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range is 18-50 years
  • Navicular drop amount is 10 mm or more
  • Getting a value of +6 points or above from the Foot Posture Index

You may not qualify if:

  • Orthopedic and rheumatological diseases of the spinal region and lower extremities
  • Surgery history of the spine and lower extremities
  • Neurological and systemic disorders
  • Describing lower extremity and/or lower back pain in the last 6 months
  • Disorders that may affect cognitive and balance (otitis media, visual impairment, etc.)
  • Having received any physiotherapy and rehabilitation treatment for flat feet or hips in the last year
  • Body mass index being above normal values (18-24.9 kg/m2)
  • Having rigid flat feet and hallux rigidus-limitus deformity
  • Doing regular sports or exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Çankaya, 06540, Turkey (Türkiye)

Location

Related Publications (5)

  • 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
  • Unver B, Erdem EU, Akbas E. Effects of Short-Foot Exercises on Foot Posture, Pain, Disability, and Plantar Pressure in Pes Planus. J Sport Rehabil. 2019 Oct 18;29(4):436-440. doi: 10.1123/jsr.2018-0363. Print 2020 May 1.

    PMID: 30860412BACKGROUND
  • Engkananuwat P, Kanlayanaphotporn R. Gluteus medius muscle strengthening exercise effects on medial longitudinal arch height in individuals with flexible flatfoot: a randomized controlled trial. J Exerc Rehabil. 2023 Feb 23;19(1):57-66. doi: 10.12965/jer.2244572.286. eCollection 2023 Feb.

    PMID: 36910682BACKGROUND
  • Choi JH, Cynn HS, Yi CH, Yoon TL, Baik SM. Effect of Isometric Hip Abduction on Foot and Ankle Muscle Activity and Medial Longitudinal Arch During Short-Foot Exercise in Individuals With Pes Planus. J Sport Rehabil. 2020 Jul 27;30(3):368-374. doi: 10.1123/jsr.2019-0310.

    PMID: 32717719BACKGROUND
  • Esen DH, Duman T, Tas S, Karatas N. Three-dimensional foot-ankle exercise versus clam exercise in addition to short-foot exercise in individuals with flexible flatfoot: a randomized controlled trial. Physiother Theory Pract. 2025 Oct;41(10):2043-2054. doi: 10.1080/09593985.2025.2492166. Epub 2025 Apr 17.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The evaluator researcher and participants will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be three groups in the study. Short-foot exercise for the control group; short-foot and 3-dimensional foot-ankle exercise for the foot-ankle group; short-foot and clam exercise will be applied for the hip group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT, Principal Investigator

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 15, 2024

Study Start

February 21, 2024

Primary Completion

March 31, 2024

Study Completion

May 1, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations