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Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus

Primary Purpose

Virtual Reality

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Exercise

Virtual Reality

About this trial

This is an interventional treatment trial for Virtual Reality focused on measuring virtual reality, foot posture, navicular drop, short foot exercise

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Have pes planus,
Volunteer for this study,
Climb 10 stairs independently,
Can stand one single leg

Exclusion Criteria:

History of trauma, fracture or operation of the foot, knee, and hip that will affect the foot
Having visual, hearing and mental problems that prevent participation in virtual reality exercises,
Being diagnosed with orthopedic or neurological problems that prevent standing on a single leg

Sites / Locations

Kırıkkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Exercise Group

Virtual Reality Group

Arm Description

One group only treated with short foot exercises.

The second group treated with virtual reality

Outcomes

Primary Outcome Measures

comparison of exercise and virtual reality treatment on balance

Y balance test measure with second (sn)

Secondary Outcome Measures

Effect of exercise on performance

10 step test measure with minute

Navicular Drop Test

Measure of navicular tubercul from floor measure with santimeter(cm)

Femoral anteversion test

measure of hip internal rotation movement actively measure with universal goniometer (degree)

Full Information

NCT ID

NCT04283357

First Posted

July 5, 2019

Last Updated

July 28, 2020

Sponsor

Hacettepe University

Collaborators

Kırıkkale University

1. Study Identification

Unique Protocol Identification Number

NCT04283357

Brief Title

Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus

Official Title

Effect of Virtual Reality on Pes Planus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 5, 2019 (Actual)

Primary Completion Date

March 10, 2020 (Actual)

Study Completion Date

March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

Collaborators

Kırıkkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Virtual reality exercises have become increasingly popular in recent years. After the increase in usage areas in daily life, its use in healthcare has become widespread. Flatfoot is one of the orthopedic problems with high prevalence, especially in young individuals. In the literature, conservative treatment methods of flat soles are mentioned as exercise, shoe modifications, and orthotic methods. In the study, it is planned to investigate whether individuals with flat-footed virtual reality exercises contribute to conservative treatment. The aim of this study was to investigate the effect of virtual reality exercises on individuals with pes planus.

Detailed Description

To show whether virtual reality exercises will contribute to decrease of flat footing, improvement of balance and increase of performance of individuals with flat foot.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Virtual Reality

Keywords

virtual reality, foot posture, navicular drop, short foot exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One group only are treated with short foot exercises. Second group are treated with short foot exercises and virtual reality.

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Group

Arm Type

Active Comparator

Arm Description

One group only treated with short foot exercises.

Arm Title

Virtual Reality Group

Arm Type

Active Comparator

Arm Description

The second group treated with virtual reality

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Short Foot Exercises

Intervention Type

Device

Intervention Name(s)

Virtual Reality

Intervention Description

Exercise with virtual reality

Primary Outcome Measure Information:

Title

comparison of exercise and virtual reality treatment on balance

Description

Y balance test measure with second (sn)

Time Frame

15 minute

Secondary Outcome Measure Information:

Title

Effect of exercise on performance

Description

10 step test measure with minute

Time Frame

10 minute

Title

Navicular Drop Test

Description

Measure of navicular tubercul from floor measure with santimeter(cm)

Time Frame

5 minute

Title

Femoral anteversion test

Description

measure of hip internal rotation movement actively measure with universal goniometer (degree)

Time Frame

5 minute

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have pes planus, Volunteer for this study, Climb 10 stairs independently, Can stand one single leg Exclusion Criteria: History of trauma, fracture or operation of the foot, knee, and hip that will affect the foot Having visual, hearing and mental problems that prevent participation in virtual reality exercises, Being diagnosed with orthopedic or neurological problems that prevent standing on a single leg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cevher Demirci, Dr

Organizational Affiliation

Kırıkkale University

Official's Role

Study Director

Facility Information:

Facility Name

Kırıkkale University

City

Kırıkkale

State/Province

Yahşihan

ZIP/Postal Code

71140

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The subjects were randomly assigned to one of the groups using an online random allocation software program. All groups were taken into a 4-week treatment program. At the end of the treatment process, it was given to subjects including VR and SF program aiming foot muscles.

Citations:

PubMed Identifier

33962115

Citation

Yildirim Sahan T, Aydogan Arslan S, Demirci C, Oktas B, Sertel M. Comparison Of Short-Term Effects Of Virtual Reality and Short Foot Exercises In Pes Planus. Foot (Edinb). 2021 Jun;47:101778. doi: 10.1016/j.foot.2021.101778. Epub 2021 Jan 21.

Results Reference

derived

Links:

URL

http://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0036-1580616

Description

Spring ligament complex and posterior tibial tendon: MR anatomy and findings in acquired adult flatfoot deformity

URL

http://journals.humankinetics.com/view/journals/jsr/21/4/article-p327.xml

Description

Differences in Static- and Dynamic-Balance Task Performance After 4 Weeks of Intrinsic-Foot-Muscle Training: The Short-Foot Exercise Versus the Towel-Curl Exercise

URL

http://www.ijhsr.org/IJHSR_Vol.10_Issue.2_Feb2020/IJHSR_Abstract.030.html

Description

Quality of Life in Adult Population with Flat Feet

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Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus

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