Virtual RealityNCT04283357
Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus
A study testing Exercise and Virtual Reality in people with Virtual Reality, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Exercise and Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have pes planus,
- Volunteer for this study,
- Climb 10 stairs independently,
- Can stand one single leg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University
Kirikkale, Yahşihan, 71140
About this study
Official title: Effect of Virtual Reality on Pes Planus
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.
Read the 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.
- Conditions
- Virtual Reality
- Being tested
- Exercise, Virtual Reality
- Keywords
- virtual reality, foot posture, navicular drop, short foot exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Short Foot Exercises
Virtual RealityDevice
Exercise with virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | One group only treated with short foot exercises. Receives: Other: Exercise |
| Virtual Reality Group | Active comparator | The second group treated with virtual reality Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of exercise and virtual reality treatment on balance
Y balance test measure with second (sn)
Measured: 15 minute
Secondary outcomes (3)
Effect of exercise on performance
10 step test measure with minute
Measured: 10 minute
Navicular Drop Test
Measure of navicular tubercul from floor measure with santimeter(cm)
Measured: 5 minute
Femoral anteversion test
measure of hip internal rotation movement actively measure with universal goniometer (degree)
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start5 Jul 2019
- Primary completion10 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group only are treated with short foot exercises. Second group are treated with short foot exercises and virtual reality.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Kırıkkale University
- Responsible party
- Principal investigator, Tezel Yıldırım Şahan, Hacettepe University
- Investigators
- Cevher Demirci, Dr, Study director, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283357
- Sponsor's protocol ID
- 2019.06.10
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33962115
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Pes Planus
- ClinicalTrials.gov ID
- NCT04283357
- Acronym / sponsor ID
- 2019.06.10
- Conditions
- Virtual Reality
- Keywords
- virtual reality, foot posture, navicular drop, short foot exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Kırıkkale University
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group only are treated with short foot exercises. Second group are treated with short foot exercises and virtual reality.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: ExerciseOne group only treated with short foot exercises. |
| Virtual Reality Group | Active comparator | Device: Virtual RealityThe second group treated with virtual reality |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have pes planus,
- Volunteer for this study,
- Climb 10 stairs independently,
- Can stand one single leg
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseShort Foot Exercises | Other | Exercise Group |
| Virtual RealityExercise with virtual reality | Device | Virtual Reality Group |
Primary outcome
comparison of exercise and virtual reality treatment on balance
Time frame: 15 minute
Y balance test measure with second (sn)
3 secondary outcomes
Effect of exercise on performance
Time frame: 10 minute
Navicular Drop Test
Time frame: 5 minute
Femoral anteversion test
Time frame: 5 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 33962115Yildirim 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.
- Spring ligament complex and posterior tibial tendon: MR anatomy and findings in acquired adult flatfoot deformityLink provided by the sponsor.
- Quality of Life in Adult Population with Flat FeetLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cevher Demirci, Dr study director
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Virtual Reality in people with Virtual Reality, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of exercise and virtual reality treatment on balance (time frame: 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.