VolleyballNCT05416801
Investigation of University Level Volleyball Players in Terms of Ankle Functions and Postural Control Variables
An observational study of Volleyball and Ankle, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is aimed to evaluate different ankle functions and postural control variables in university level volleyball players and students with stable ankles and to examine the results obtained. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Volleyball, Ankle, Postural Balance
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2022to 8 Feb 2023
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study was carried out with female individuals aged 18-25 who have stable ankles and have not had an ankle injury in the last 1 year. The study includes volleyball players playing in university teams and healthy university students who meet the same criteria.
Who may be able to join
- Female gender,
- Being between the ages of 18-25,
- Having a score of ≥24 on the Cumberland Ankle Instability Questionnaire,
- Volunteering for the study.
Who cannot join
- Presence of neuromuscular system disease,
- Presence of vestibular or visual problems,
- Presence of acute or chronic pain,
- An ankle injury in the last year,
- For the control group, regular participation in sports activities or physical activity for more than 150 minutes, 5 days a week.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, it is aimed to evaluate different ankle functions and postural control variables in university level volleyball players and students with stable ankles and to examine the results obtained. In this way, we aim to contribute to the physiotherapy and rehabilitation literature and clinical studies of physiotherapists who are interested in athlete health.
The hypothesis set in this study is:
H0: There is no difference between ankle functions and postural control variables of volleyball players and healthy controls.
H1: There is a difference between ankle functions and postural control variables of volleyball players and healthy controls.
Read the detailed description
There are studies proving that athletes with poor postural control have a higher risk of injury to the ankle and knee regions than those with normal. Balanced stance and effective postural control in activities involving ball contact during the game are the basic skills of volleyball. The ankle is a joint that needs to be evaluated frequently and its functions should be improved both in order to improve postural control ability and to prevent possible injuries. It has been proven in studies that the capacity shown in different functional parameters such as joint range of motion, strength and proprioception and balance both reduces the risk of injury and positively reflects on the performance parameters of the athlete. It will be useful to evaluate and examine the ankle functions and postural controls that change as a result of the training and exercises performed by the athletes, unlike healthy individuals who are not athletes, in order to understand the abilities developed specifically for the sport.
The study will be carried out in Yeditepe University Physiotherapy and Rehabilitation Graduate Laboratory. Female individuals aged 18-25 years, with stable ankles will be included in the study as a sample. The study will consist of two groups. The first group will include volleyball players playing in university teams, and healthy university students meeting the same criteria in the control group. The sample size of the study was calculated using the GPower program as type 1 error value= 0.05, power = 0.90, effect size (f value) calculated from the reference article and total of 40 subjects for the independent sample t-test.
The Cumberland Ankle Instability Tool will be used to select suitable participants for the study. Only ankles considered stable according to the questionnaire will be included in this study. First, static balance will be evaluated with the PK Prokin 252 system during the silent stand for postural control assessment. Then, different ankle functions of the people who will participate in the study will be evaluated. The measurement of the range of motion of the ankle will be evaluated with the help of a goniometer. Different degrees of position sense of the ankle joint will be evaluated with the aid of a goniometer and the sense of vibration will be evaluated with a tuning fork. Muscle strength will be measured with the help of a manual dynamometer during the movements of the muscles around the ankle. In addition, the participants who volunteered to participate in the study before the tests will be given a Voluntary Consent Form and a Demographic Information Form. Participants will be given rest periods between each test. Evaluation time will be 45 minutes for each participant. Participants will not be followed up after the assessments.
- Conditions
- Volleyball, Ankle, Postural Balance
- Keywords
- postural control, ankle, range of motion, strenght, vibration, proprioception, volleyball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Volleyball Group | Female Volleyball players who are currently playing in a university team and who are meeting the inclusion criteria. | |
| Control Group | Female university students who are meeting the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control
Postural control is evaluated according to the results of the static stability test performed on the PK Prokin 252 balance device with proven reliability. Postural control outcome is measured by the findings of the Prokin System, wich are: Average center of gravity on the X-axis (mm), Average Y-axis center of gravity (mm), Forward-backward standard deviation (mm), Medial-lateral standard deviation (mm) variables.
Measured: Baseline
Ankle Joint Range of Motion
Range of motion assessment is made using a goniometer. Dorsiflexion and plantarflexion in the tibiotalar joint, and eversion and inversion in the subtalar joint is evaluated both actively and passivley. These evaluations will be repeated 3 times and their averages will be recorded.
Measured: Baseline
Ankle Joint Proprioception
The assessment is made by a goniometer. First the referance degree is passively tought and then while eyes are closed, the person tries to reach the referance degree. The movements starts from 145 degrees of plantar flexion to the degrees of 105, 120, 130 and 140.
Measured: Baseline
Vibration Sense
Vibration evaluation is made with the help of tuning fork (128 Hz). The eyes are closed throughout the application. Reference points are the big toe, fifth toe, and medial malleolus. The person is instructed to say when the feeling of vibration ends. A timer was used to count the time.
Measured: Baseline
Ankle Joint Muscle Strength
The maximum isometric strength of the ankle is evaluated with the manual dynamometer measurement, the validity and reliability of which has been proven. JTECH Commander Powertrack Manual Dynamometer was used for measurements. Dorsiflexion, plantar flexion, eversion and inversion movements are assessed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start25 Aug 2022
- Primary completion24 Jan 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolleyballStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University
- Responsible party
- Principal investigator, Aysem Ecem Ozdemir, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416801
- Sponsor's protocol ID
- YU001
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of University Level Volleyball Players in Terms of Ankle Functions and Postural Control Variables
- ClinicalTrials.gov ID
- NCT05416801
- Acronym / sponsor ID
- YU001
- Conditions
- Volleyball, Ankle, Postural Balance
- Keywords
- postural control, ankle, range of motion, strenght, vibration, proprioception, volleyball
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Collaborators
- Yeditepe University
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 13 Jun 2022 (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.
In this study, it is aimed to evaluate different ankle functions and postural control variables in university level volleyball players and students with stable ankles and to examine the results obtained. In this way, we aim to contribute to the physiotherapy and rehabilitation literature and clinical studies of physiotherapists who are interested in athlete health.
The hypothesis set in this study is:
H0: There is no difference between ankle functions and postural control variables of volleyball players and healthy controls.
H1: There is a difference between ankle functions and postural control variables of volleyball players and healthy controls.
Detailed description
There are studies proving that athletes with poor postural control have a higher risk of injury to the ankle and knee regions than those with normal. Balanced stance and effective postural control in activities involving ball contact during the game are the basic skills of volleyball. The ankle is a joint that needs to be evaluated frequently and its functions should be improved both in order to improve postural control ability and to prevent possible injuries. It has been proven in studies that the capacity shown in different functional parameters such as joint range of motion, strength and proprioception and balance both reduces the risk of injury and positively reflects on the performance parameters of the athlete. It will be useful to evaluate and examine the ankle functions and postural controls that change as a result of the training and exercises performed by the athletes, unlike healthy individuals who are not athletes, in order to understand the abilities developed specifically for the sport.
The study will be carried out in Yeditepe University Physiotherapy and Rehabilitation Graduate Laboratory. Female individuals aged 18-25 years, with stable ankles will be included in the study as a sample. The study will consist of two groups. The first group will include volleyball players playing in university teams, and healthy university students meeting the same criteria in the control group. The sample size of the study was calculated using the GPower program as type 1 error value= 0.05, power = 0.90, effect size (f value) calculated from the reference article and total of 40 subjects for the independent sample t-test.
The Cumberland Ankle Instability Tool will be used to select suitable participants for the study. Only ankles considered stable according to the questionnaire will be included in this study. First, static balance will be evaluated with the PK Prokin 252 system during the silent stand for postural control assessment. Then, different ankle functions of the people who will participate in the study will be evaluated. The measurement of the range of motion of the ankle will be evaluated with the help of a goniometer. Different degrees of position sense of the ankle joint will be evaluated with the aid of a goniometer and the sense of vibration will be evaluated with a tuning fork. Muscle strength will be measured with the help of a manual dynamometer during the movements of the muscles around the ankle. In addition, the participants who volunteered to participate in the study before the tests will be given a Voluntary Consent Form and a Demographic Information Form. Participants will be given rest periods between each test. Evaluation time will be 45 minutes for each participant. Participants will not be followed up after the assessments.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volleyball Group | – | –Female Volleyball players who are currently playing in a university team and who are meeting the inclusion criteria. |
| Control Group | – | –Female university students who are meeting the inclusion criteria. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study was carried out with female individuals aged 18-25 who have stable ankles and have not had an ankle injury in the last 1 year. The study includes volleyball players playing in university teams and healthy university students who meet the same criteria.
Key inclusion criteria (4 listed)
- Female gender,
- Being between the ages of 18-25,
- Having a score of ≥24 on the Cumberland Ankle Instability Questionnaire,
- Volunteering for the study.
Key exclusion criteria (5 listed)
- Presence of neuromuscular system disease,
- Presence of vestibular or visual problems,
- Presence of acute or chronic pain,
- An ankle injury in the last year,
- For the control group, regular participation in sports activities or physical activity for more than 150 minutes, 5 days a week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postural control
Time frame: Baseline
Postural control is evaluated according to the results of the static stability test performed on the PK Prokin 252 balance device with proven reliability. Postural control outcome is measured by the findings of the Prokin System, wich are: Average center of gravity on the X-axis (mm), Average Y-axis center of gravity (mm), Forward-backward standard deviation (mm), Medial-lateral standard deviation (mm) variables.
Ankle Joint Range of Motion
Time frame: Baseline
Range of motion assessment is made using a goniometer. Dorsiflexion and plantarflexion in the tibiotalar joint, and eversion and inversion in the subtalar joint is evaluated both actively and passivley. These evaluations will be repeated 3 times and their averages will be recorded.
Ankle Joint Proprioception
Time frame: Baseline
The assessment is made by a goniometer. First the referance degree is passively tought and then while eyes are closed, the person tries to reach the referance degree. The movements starts from 145 degrees of plantar flexion to the degrees of 105, 120, 130 and 140.
Vibration Sense
Time frame: Baseline
Vibration evaluation is made with the help of tuning fork (128 Hz). The eyes are closed throughout the application. Reference points are the big toe, fifth toe, and medial malleolus. The person is instructed to say when the feeling of vibration ends. A timer was used to count the time.
Ankle Joint Muscle Strength
Time frame: Baseline
The maximum isometric strength of the ankle is evaluated with the manual dynamometer measurement, the validity and reliability of which has been proven. JTECH Commander Powertrack Manual Dynamometer was used for measurements. Dorsiflexion, plantar flexion, eversion and inversion movements are assessed.
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 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volleyball and Ankle, run by Istanbul Gelisim 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 5 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 15 Feb 2023. 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?
Postural control (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.