Comparison of Exercise Effects in Individuals With Flatfoot

NCT ID: NCT06313125

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2024-05-01

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.

Detailed Description

This study was designed as an experimental, 3-arm, parallel group, single-blind randomized controlled study that included a 6-week intervention period. The study will be carried out in the university physiotherapy and exercise laboratory. Flat-footed individuals aged between 18-50 years will be included in this study. G-Power (Windows version 3.1.9.7) statistical program was used to determine the number of participants. Sample size calculation was made based on a similar study in the literature that evaluated the amount of navicular drop after foot intrinsic muscle strength training (the primary outcome measure of this study). Type 1 error probability 0.01; The power was accepted as 0.90 and the number of samples was determined as at least 15 people for each group. By adding the 20% loss rate to this number, it was decided that the required number of participants would be 20 people in total for each group. Participants who were confirmed to be included in the study were evaluated by the lead investigator, who was not involved in the evaluations, using Random Allocation Software (version 2.0) in a single block format, 3-dimensional foot-ankle exercise group (foot muscle exercise group, AEG), hip abductor and external rotator strengthening exercise. will be allocated to three different groups: group (hip muscles exercise group, KEG) and control group (CG). The investigator performing the assessments will be blinded to group allocation. Recording of groups' demographic information and assessment of outcome measures will be performed by a secondary investigative physical therapist who is blinded to group information. The principal investigator physiotherapist will be responsible for training the participants to perform the exercises assigned to them, communicating with the participants to monitor exercise performance and exercise compliance, allocating the groups and ensuring blinding. Outcome measurements will be repeated at the start of treatment and at the end of treatment.

Conditions

Flat Foot [Pes Planus] (Acquired), Unspecified Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Foot-ankle exercise group

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.

Group Type: EXPERIMENTAL

3-dimensional foot-ankle extension exercises

Intervention Type: OTHER

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.

Short-foot exercise

Intervention Type: OTHER

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.

Hip exercise group

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.

Group Type: ACTIVE_COMPARATOR

Clam exercise

Intervention Type: OTHER

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.

Short-foot exercise

Intervention Type: OTHER

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 group

The control group will do only short-foot exercise.

Group Type: ACTIVE_COMPARATOR

Short-foot exercise

Intervention Type: OTHER

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.

Interventions

3-dimensional foot-ankle extension exercises

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.

Intervention Type: OTHER

Clam exercise

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.

Intervention Type: OTHER

Short-foot exercise

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.

Intervention Type: OTHER

Other Intervention Names

Short-foot exercise; Short-foot exercise

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mustafa Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Dilek Hande Esen

MSc, PT, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 36231295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30860412 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36910682 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32717719 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40244701 (View on PubMed)

Related Links

https://www.balticsportscience.com/journal/vol14/iss4/4/

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Other Identifiers

E-77082166-302.08.01-796166

Identifier Type: -

Identifier Source: org_study_id