NCT05679219

Brief Summary

Purpose: It is aimed to evaluate the effect of structured exercise, wii-based exergame and wii-based serious game exercise protocols on functional parameters in individuals with pes planus. Method: 69 individuals with Pes Planus between the ages of 18-25 who met the inclusion criteria will be included in the study. Pedobarographic analysis, navicular drop test, flexibility, balance, femoral anteversion and lower extremity muscle strength measurements will be performed on the participants before and after the treatment. In addition, demographic information of individuals will be recorded through a survey. After the initial evaluation, participants will be randomly assigned to one of three groups. All subjects participating in the study will be treated under the supervision of a specialist physiotherapist for a total of 18 sessions, 3 days a week for 6 weeks, 40 minutes each session. Structured exercise group; short foot exercise, towel curl exercise, toe walking, heel walking, tandem walking, eccentric gastrosoleus stretching at the edge of the stairs, collecting objects from the ground with the toes, balance exercises on one foot will be performed. Penguin Slide, Tightrople Tension, Tilt Table, Soccer Heading and Balance Bubble games, which are balance games of the Nintendo wii game console, will be played for the Wii-based exergame group for 8 minutes each and a total of 40 minutes per session. For Wii-based serious game group, 3 games, Balance Surf, Balance Adventure and Balance Maze, which are among the balance games included in the Becure Balance System that works integrated with the Wii Balance Board, will be played for 40 minutes each session under the supervision of an expert physiotherapist. After the treatment, all measurements will be repeated, the difference between before and after treatment and the superiority of different treatment protocols will be tried to be determined.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

December 15, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

December 21, 2022

Last Update Submit

September 27, 2023

Conditions

Keywords

ExergameVirtual RealityPes PlanusVideogamesSerious game

Outcome Measures

Primary Outcomes (4)

  • Navicular Drop Test

    The severity of the pes planus will be determined by the navicular drop test. The person will be asked to sit on a chair with bare feet touching the ground without giving any weight, the navicular tubercle will be found on the medial of the foot and the height from the ground will be marked on a plain white card. Then, the person will be asked to stand up and the level of the navicular tubercle in the collapsed medial arch with full weight-bearing will be marked again on the same card. The difference will be recorded in centimeters, the measurement will be repeated for each foot. As a result of the exercises, the measurement will be repeated and it will be checked whether the difference has decreased.

    10 minutes

  • Static foot pressure analysis

    Static foot pressure analysis; It will be done with a Sensor Medica Maxi brand pedobarographic analyzer. The person is asked to stand in a comfortable position in a certain area of the platform, barefoot, heels at the same level, feet in the width of the pelvis for 5 seconds, still and upright. In the static analysis, the valgus angle of the ankle will be evaluated separately for the right and left feet. The captured images and data will be transferred to the computer via Freestep software and saved.

    5 minutes

  • Dynamic foot pressure analysis

    Dynamic foot pressure analysis; It will be done with Sensor Medica Maxi brand pedobarographic analyzer compatible with Freestep software. Variables will be recorded by executing 6 laps at normal walking pace on a 2 meter platform. In the dynamic analysis, the contact area (cm²) of the anterior, middle and posterior parts of the foot, the medial longitudinal arch, the lateral longitudinal arch, the contact area of the medial heel with the ground (cm²) will be recorded separately for the right and left feet.

    10 minutes

  • Flexibility

    The Jack's finger lift test will be used to assess whether the pes planus is flexible. The toe will be passively dorsiflexed by the therapist when the patient feels comfortable and does not put weight on the foot in the sitting position, while the medial longitudinal arch rises will be interpreted in favor of flexible pes planus. Flexibility assessment will be made at the beginning of the study, no elevation in the medial longitudinal arch during testing will be considered as rigid pes planus and these individuals will not be included in the study.

    5 minutes

Secondary Outcomes (3)

  • Femoral anteversion

    10 minutes

  • Balance

    10 minutes

  • Muscle strength

    20 minutes

Study Arms (3)

Structured Pes Planus Exercise Group

ACTIVE COMPARATOR

23 individuals will be included in this group. Structured pes planus exercise group; short foot exercise, towel picking exercise, toe walking, heel walking, tandem walking, eccentric gastrosoleus stretching at the edge of the stairs, picking objects from the ground with the toes, balance exercises on one foot. The purpose of all these exercises; The aim is to increase the medial longitudinal arch by contracting the intrinsic muscles of the foot, and to improve the balance at the same time. Walking exercises will be performed in the form of 10 meters and 10 rounds, other exercises will be performed with 30 repetitions for both feet and the whole session will be 40 minutes in total.

Procedure: Structured Pes Planus Exercises

Wii Based Exergame Group

ACTIVE COMPARATOR

23 individuals will be included in this group. Wii-based exergame group, Nintendo wii game console balance games; In the literature, frequently used ones in different disease groups will be selected and played. In this context, Penguin Slide, Tightrople Tension, Tilt Table, Soccer Heading and Balance Bubble games will be played in each session under the supervision of an expert physiotherapist (executive), each game will be 8 minutes and the session will be 40 minutes in total. The motion sensor will be placed directly opposite the Balance Board. All games are played in a standing upright position on a double-footed Balance Board.

Procedure: Wii Based Exergame

Wii Based Serious Game Group

ACTIVE COMPARATOR

23 individuals will be included in this group. The lower extremity strengthening and balance exercises within the Becure Balance System, developed in cooperation with the Physiotherapist, Academician and Engineer, will be performed by the Wii-based serious game group through the Wii Balance Board. Three games, Balance Surf, Balance Adventure and Balance Maze, which are among the balance games within the Becure Balance System application, will be played for 40 minutes in each session under the supervision of an expert physiotherapist (executive). The Wii Balance Board will be connected via Bluetooth from the menu in the Becure application. Then the Person will stand on the Balance Board and transfer weight in four directions in line with the instructions of the game on the screen.

Procedure: Wii Based Serious Game

Interventions

Structured pes planus exercise group; short foot exercise, towel picking exercise, toe walking, heel walking, tandem walking, eccentric gastrosoleus stretching at the edge of the stairs, picking objects from the ground with the toes, balance exercises on one foot. the purpose of all these exercises; The aim is to increase the medial longitudinal arch by contracting the intrinsic muscles of the foot, and to improve the balance at the same time. Walking exercises will be performed in the form of 10 meters and 10 rounds, other exercises will be performed with 30 repetitions for both feet and the whole session will be 40 minutes in total.

Structured Pes Planus Exercise Group

Wii-based exergame group, Nintendo wii game console balance games; In the literature, frequently used ones in different disease groups will be selected and played. In this context, Penguin Slide, Tightrople Tension, Tilt Table, Soccer Heading and Balance Bubble games will be played in each session under the supervision of an expert physiotherapist (executive), each game will be 8 minutes and the session will be 40 minutes in total. The motion sensor will be placed directly opposite the Balance Board. All games are played in a standing upright position on a double-footed Balance Board.

Wii Based Exergame Group

The lower extremity strengthening and balance exercises within the Becure Balance System, developed in cooperation with the Physiotherapist, Academician and Engineer, will be performed by the Wii-based serious game group through the Wii Balance Board. Three games, Balance Surf, Balance Adventure and Balance Maze, which are among the balance games within the Becure Balance System application, will be played for 40 minutes in each session under the supervision of an expert physiotherapist (executive). The Wii Balance Board will be connected via Bluetooth from the menu in the Becure application. Then the Person will stand on the Balance Board and transfer weight in four directions in line with the instructions of the game on the screen.

Wii Based Serious Game Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Those between the ages of 18-25
  • Diagnosed with pes planus by pedobarographic evaluation
  • Those with flexible pes planus
  • Have more than 10 mm navicular drop
  • Those who have not received insoles or exercise therapy before
  • Volunteers will be included in the study.

You may not qualify if:

  • Having another soft tissue or bone problem affecting the foot and lower extremity
  • Having any orthopedic and neurological problems affecting balance
  • History of surgery or trauma in the last 6 months
  • Cardiopulmonary, visual or auditory problems
  • Diabetic and pregnant individuals will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, İ̇stanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Erten AB, Tarakci D, Cacan MA. The Effectiveness of Video-Based Game Exercise Therapy Applications in Pes Planus Rehabilitation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 11;12:e51772. doi: 10.2196/51772.

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

  • Ayşe Büşra Erten

    İstanbul Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Büşra Erten

CONTACT

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

December 21, 2022

First Posted

January 10, 2023

Study Start

December 15, 2022

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations