Video-Based Gaming Therapy in Pes Planus Rehabilitation

September 27, 2023 updated by: ayse busra erten, Istanbul Medipol University Hospital

The Effect of Wii-Based Game Exercise Therapy Applications on Functional Parameters in Pes Planus Rehabilitation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • İ̇stanbul
      • İstanbul, İ̇stanbul, Turkey
        • Recruiting
        • Istanbul Medipol University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Navicular Drop Test
Time Frame: 10 minutes
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
Time Frame: 5 minutes
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
Time Frame: 10 minutes
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
Time Frame: 5 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Femoral anteversion
Time Frame: 10 minutes
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.
10 minutes
Balance
Time Frame: 10 minutes
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.
10 minutes
Muscle strength
Time Frame: 20 minutes
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.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe Büşra Erten, Istanbul Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • aberten

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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