ClinicalTrials.gg
RecruitingNCT05679219Updated Sep 29, 2023

Video-Based Gaming Therapy in Pes Planus Rehabilitation

An interventional study of Structured Pes Planus Exercises and Wii Based Exergame in Serious Game, Videogames and Pes Planus, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Serious Game
  • Videogames
  • Pes Planus
  • Virtual Reality
  • Exergame

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Keywords

  • Exergame
  • Virtual Reality
  • Pes Planus
  • Videogames
  • Serious game
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 69 is above the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 366 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
69 participants (estimated)

Study arms

  • Active comparator
    Structured Pes Planus Exercise Group

    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

  • Active comparator
    Wii Based Exergame Group

    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

  • Active comparator
    Wii Based Serious Game Group

    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

  • ProcedureStructured Pes Planus Exercises

    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.

  • ProcedureWii Based Exergame

    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.

  • ProcedureWii Based Serious Game

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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.

    Time frame: 5 minutes

  3. 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.

    Time frame: 10 minutes

  4. 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.

    Time frame: 5 minutes

Secondary outcomes

  1. Femoral anteversion

    Femoral anteversion angle of individuals will be evaluated with Craig test. The person will be asked to internally rotate each lower extremity, respectively, in the prone position with the knees flexed to 90 degrees. The angle formed at this time will be measured with a goniometer. In order for the movement not to be compensated, care will be taken that the opposite hip does not rise from the bed. Each measurement will be repeated three times and the average value recorded.

    Time frame: 10 minutes

  2. Balance

    Balance measurements of the participants will be evaluated with the Becure Balance System, which works integrated with the Wii. In this system, balance center change, balance center position, weight and weight pressure data taken from 4 corner points of the device are obtained by using Balance Board balance device. The system includes image/imageless, eyes open/closed and intermittent measurement parameters. Before the measurement, the Wii Balance Board is connected to the Becure application via bluetooth connection. During the measurement period, the person to be measured must stand still on the balance device. In this context, while individuals are on the Balance Board, barefoot for 15 seconds; Measurements will be taken in four different positions with eyes open on two feet, eyes closed on two feet, and eyes open on one foot (right and left, respectively). The system reports the oscillation (movement distance) made by the person to stay in balance during the measurements in cm.

    Time frame: 10 minutes

  3. Muscle strength

    lower extremity of the participants; Muscle strength of dorsi flexor, plantar flexor, inverter, evertor, knee flexor, knee extensor and hip flexor muscle groups will be measured with a myometer device. After the individual is positioned during muscle strength measurement, the myometer is placed on the distal side of the area to be measured. Until the person loses his position, he continues to create force in the opposite direction with the myometer. Dorsiflexor, plantar flexor, inverter and evertor muscle groups will be measured in the long sitting position. Measurement of knee extensor and hip flexor muscles in sitting position; Knee flexor muscle strength will be measured in the prone position. During the measurements, the individual will be prevented from getting support from the upper extremity and the bed. The average value in Newtons will be recorded after all measurements have been repeated three times.

    Time frame: 20 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05679219
Responsible party
ayse busra erten (Lecturer, Istanbul Medipol University Hospital) — Principal investigator
First posted
Jan 10, 2023
Start date
Dec 15, 2022
Primary completion
Jan 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Sep 29, 2023

Study contacts

Ayşe Büşra Erten
Contact
abertenn@gmail.com
05315983789
Ayşe Büşra Erten
principal investigator · İstanbul Medipol University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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