NCT05788406

Brief Summary

The purpose of this study is to investigate the effects of intrinsic strengthening and dynamic balance exercises in patients with flexible pes planus. Forty-five participants aged 18 to 35 years were enrolled in the study, and the first group underwent intrinsic foot muscle strengthening training with short foot exercises (SFE) and used insoles. The second group trained using the dynamic balance board, which promotes dynamic balance and used insoles. The third group used only insoles. The total duration of treatment was 8 weeks/3 days. The degree of foot deformity was assessed with the, medial longitudinal arch (MLA) angle, measurements of subtalar angle and navicular drop test. Foot position assessed using Foot Posture Index (FPI) Static balance was assessed with the Flamingo Balance Test and dynamic balance with the " BOBO Health Platform with Gaming®" device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

March 14, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

March 14, 2023

Last Update Submit

June 24, 2023

Conditions

Keywords

flexible pes planusinsolebalance

Outcome Measures

Primary Outcomes (1)

  • Dynamic Balance performance

    Dynamic balance was assessed using the BOBO Gaming Health Platform. With this system, which acts as a computerized strength platform, there are assessment and treatment phases. The individual was performed with the foot being tested on 2 sides of the platform. In all these evaluations, parameters related to body balance were analyzed. It gives performance scores in terms of percent.

    0-8 week

Secondary Outcomes (4)

  • Foot Posture Index Score

    0-8 week

  • Subtalar angle

    0-8 week

  • Static Balance Assessment

    0-8 week

  • Angle of Medial longitudinal Arch

    0-8 week

Study Arms (3)

Short Foot Exercises Group

EXPERIMENTAL

İnsole+Short Foot Exercises group

Other: Short foot exercises, Dynamic balance exercises and insole

Balance Exercises Group

EXPERIMENTAL

İnsole+Balance exercises group

Other: Short foot exercises, Dynamic balance exercises and insole

Control Group

EXPERIMENTAL

İnsole group

Other: Short foot exercises, Dynamic balance exercises and insole

Interventions

Short foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA

Balance Exercises GroupControl GroupShort Foot Exercises Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients were included in the study if they were 152° above the MLA, participants with flexible pes planus at the 1st, 2nd, and 3rd level according to Jack's test, between 18 and 35 years of age, and had not received previous treatment for pes planus.

You may not qualify if:

  • Individuals who had previously used orthotics, who had an orthopedic injury to the ankle, and who did not wish to participate in the study were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

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

Study Officials

  • EylÜL pINAR Kısa

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 28, 2023

Study Start

March 14, 2023

Primary Completion

May 1, 2023

Study Completion

June 15, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations