NCT06482580

Brief Summary

In the study, the effects of two different strengthening exercises combined with short foot exercise on lower extremity functional performance and muscle strength will be examined and compared in adults aged 18-45 years with flexible flatfoot. This study was designed as an experimental, 3-arm, parallel group, double-blind randomized controlled study that included a 6-week intervention period.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

June 26, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

Foot deformitiesIntrinsic foot muscle trainingMuscle strengheningShort-foot exercisesPerformanceProprioceptive neuromuscular facilitation

Outcome Measures

Primary Outcomes (2)

  • Medial longitudinal arch height

    Medial longitudinal arch height will be evaluated with the navicular drop test.

    6 weeks

  • Static foot posture

    Static foot posture will be evaluated with Foot Posture Index-6.

    6 weeks

Secondary Outcomes (2)

  • Isometric muscle strength

    6 weeks

  • Lower extremity functional performance

    6 weeks

Study Arms (3)

PNF exercise group

EXPERIMENTAL

All groups will be subjected to exercise training for 6 weeks: PNF exercise group will receive 3-dimensional (3D) foot-ankle extension exercise and short-foot exercise. The exercise will be performed 2 days a week under the supervision of a physiotherapist and 1 day as home exercise; KA exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.

Other: PNF exerciseOther: Short-foot exercise

Clam exercise group

EXPERIMENTAL

All groups will be subjected to exercise training for 6 weeks: Clam exercise group will receive mussel exercise and short-foot exercise. The exercise will be performed 2 days a week under the supervision of a physiotherapist and 1 day as home exercise; KA exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.

Other: Clam exerciseOther: Short-foot exercise

Control group

ACTIVE COMPARATOR

All groups will be subjected to exercise training for 6 weeks: Control group will receive only KA exercise and this exercise will be performed daily, 2 days under the supervision of a physiotherapist and the other days as home exercise.

Other: Short-foot exercise

Interventions

Ankle and foot exercises practiced for 6 weeks.

PNF exercise group

Hip exercise practiced for 6 weeks.

Clam exercise group

Foot exercise practiced together for 6 weeks.

Clam exercise groupControl groupPNF exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range is 18-45 years
  • Navicular drop is 10 mm or more
  • Getting a value of +6 points or more from the Foot Posture Index-6

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
  • Describe lower extremity and/or lower back pain in the last 6 months
  • Disorders that may affect cognition and balance (otitis media, visual impairment, etc.)
  • Body mass index being above normal values (18-24.9 kg/m2)
  • Having rigid flat feet and/or hallux rigidus-limitus deformity
  • Being involved in regular sports or exercise
  • Having received any physiotherapy or rehabilitation treatment for flat feet or hips in the last year

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 (4)

  • 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
  • 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
  • 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.

    PMID: 31590069BACKGROUND
  • Pabon-Carrasco M, Castro-Mendez A, Vilar-Palomo S, Jimenez-Cebrian AM, Garcia-Paya I, Palomo-Toucedo IC. Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation. Int J Environ Res Public Health. 2020 Jul 7;17(13):4882. doi: 10.3390/ijerph17134882.

    PMID: 32645830BACKGROUND

MeSH Terms

Conditions

FlatfootFoot Deformities

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dilek Esen, PhD. c

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The primary researcher will ensure blinding. Participants and the researcher conducting the assessments will be blinded to group information.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was designed as an experimental, 3-arm parallel-group, double-blind randomized controlled trial with a 6-week intervention period. The study will be conducted at Toros University physiotherapy and exercise laboratory.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT, Principal Investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 1, 2024

Study Start

April 30, 2024

Primary Completion

July 30, 2024

Study Completion

September 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations