NCT04283357

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

July 5, 2019

Last Update Submit

July 28, 2020

Conditions

Keywords

virtual realityfoot posturenavicular dropshort foot exercise

Outcome Measures

Primary Outcomes (1)

  • comparison of exercise and virtual reality treatment on balance

    Y balance test measure with second (sn)

    15 minute

Secondary Outcomes (3)

  • Effect of exercise on performance

    10 minute

  • Navicular Drop Test

    5 minute

  • Femoral anteversion test

    5 minute

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

One group only treated with short foot exercises.

Other: Exercise

Virtual Reality Group

ACTIVE COMPARATOR

The second group treated with virtual reality

Device: Virtual Reality

Interventions

Short Foot Exercises

Exercise Group

Exercise with virtual reality

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, Yahşihan, 71140, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cevher Demirci, Dr

    Kırıkkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group only are treated with short foot exercises. Second group are treated with short foot exercises and virtual reality.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 5, 2019

First Posted

February 25, 2020

Study Start

July 5, 2019

Primary Completion

March 10, 2020

Study Completion

March 20, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

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.

Locations