Healthy Young WomenNCT05594628
Perturbation Based Neuromuscular Training Effects on Peroneal Strength, Fatigue and Functional Performance Parameters
A study testing Neuromuscular training in people with Healthy Young Women and Basketball Players, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
In the literature neuromuscular exercise programs are often used for prevention in sport players. Literature lacks of perturbation exercises and its effects on peroneal's muscle strength, fatigue and individual's performance parameters. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Women, Basketball Players
- What is being tested?
- Neuromuscular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 31 Aug 2022to 4 Aug 2023
- 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 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy, non-injured within the 6 months female basketball players that are willing to join the research
Who cannot join
- That has a injury within 6 months with missing trainings at least 2 times in a row or having vestibuler dysfunction
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acıbadem University
Istanbul
Istanbul University
Istanbul
About this study
Official title: The Effects of Neuromuscular Training on Peroneal Eccentric Strength, Fatigue and Functional Performance in Young Women Basketball Players
In the literature neuromuscular exercise programs are often used for prevention in sport players. Literature lacks of perturbation exercises and its effects on peroneal's muscle strength, fatigue and individual's performance parameters. This study will investigate if it is possible to achieve improvements on peroneal eccentric strength, fatigue, dynamic balance and individual's performance with the exercises mainly based on side perturbations.
Read the detailed description
Chronic ankle instability is very common in adolescent female basketball players. In the literature neuromuscular exercise programs are often used for prevention in sport players that usually contains of strength and/or balance exercises. Perturbation exercises are oftenly used in sport players for returning the sport or prevention but literature lacks of its effects statistically. This study will investigate if it is possible to achieve improvements on peroneal eccentric strength, fatigue, dynamic balance and individual's performance with the exercises mainly based on side perturbations. Strength and fatigue evaluations will be made with Cybex dynanometer. Dynamic balance evaluations will be made with Y-Balance Tests. Individual's performance parameter evaluations will be made with vertical jump test, cross jump test and side hop test.
- Conditions
- Healthy Young Women, Basketball Players
- Being tested
- Neuromuscular training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular trainingOther
Neuromuscular training is designed as 8 weeks and 2 times a week, and approximately 20 minutes per session for Neuromuscular training+usual basketball training group. Other group is only going to keep attending usual basketball training.
Neuromuscular training consisted 3 exercises:
First exercise is passing the ball to side to side on bosu with standing on one leg. 60-90 seconds on time, 30-60 seconds off time. 2 sets for both passing sides and bilaterally.
Second exercise is standing on bosu unilaterally and while standing stabilized, switching basketball hand to hand as dribbling on the floor. Exercise will be on for 60-90 seconds and off for 30-60 seconds, 2 sets for each side Third exercise is jumping with one stance/leg, and landing with double stance while a therabant is attached to the belly and pulling with a minimum/medium force from one side. Changing legs after one jump, 6 times for both side is equal to 1 set of the exercise. It will be done 2 sets for both sides.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training+Basketball training | Experimental | After all participiants are evaluated, they will be divided randomly to two groups, which one group will be taking neuromuscular training+usual basketball training Receives: Other: Neuromuscular training |
| Control group(Basketball training) | No intervention | After all participiants are evaluated, they will be divided randomly to two groups, which one group will be taking just the usual basketball training and not any extra interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Peroneal eccentric strength
Force will be evaluated with Cybex Humac NORM, as Nm/kg(Newton-meters/kg). At 30° /s speed, 3 trials will be made with submaximal force for participants to understand the movement. After trials 4 maximal strength repetition will be made. Highest repetition, and average of 4 repetition will be used for analysis. Before and after the intervention evaluation will be made.
Measured: 10 weeks
Changes in Peroneal endurance parameters
Endurance will be evaluated with Cybex Humac NORM, as Nm/kg(Newton-meters/kg). At 180° /s speed, 5 trials will be made with submaximal force for participants to understand the movement. After trials 20 maximal strength repetition will be made. Endurance is described as containing strength for a duration of time, it can be evaluted with Fatigue index/Endurance parameters will be evaluated with comparing last 10 repetion to first 10 repetion to assess the difference. Before and after the intervention evaluation will be made.
Measured: 10 weeks
Secondary outcomes (4)
Changes in Dynamic Balance
It will be evaluated with Y Balance test to anterior, posteromedial, posterolateral sides. The distance will be recorded with cm's. Before and after the intervention evaluation will be made.
Measured: 10 weeks
Changes in Cross Hop Test
It will be evaluated through cross jumping 3 times on a 6 meter-line. The distance will be recorded wtih cm's. Before and after the intervention evaluation will be made.
Measured: 10 weeks
Changes in Vertical Jump Test
It will be evaluated with Takei Jumpmeter. The height of the jump will be recorded with Takei Jumpmetre with cm's. Before and after the intervention evaluation will be made.
Measured: 10 weeks
Changes in Side Hop Test
2 lines with 30 cm distance will be placed. Players will complete 10 jumping from side to side without stepping on the lines. Unsuccessfull jumps will be excluded. The time will be recorded with chronometer. Before and after the intervention evaluation will be made.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start31 Aug 2022
- Primary completion15 Jun 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Healthy Young WomenStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After first evaluation groups are randomly assigned to 2 groups. Both groups keep attending basketball trainings. One group is just going to keep attending basketball trainings, one group is going to keep attending usual basketball trainings and going to receive neuromuscular training that will be added in warming up exercises
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Ozge Kocaer, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594628
- Sponsor's protocol ID
- 1108799
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gribble PA, Robinson RH. Alterations in knee kinematics and dynamic stability associated with chronic ankle instability. J Athl Train. 2009 Jul-Aug;44(4):350-5. doi: 10.4085/1062-6050-44.4.350.
PubMed 19593416Taylor JB, Ford KR, Nguyen AD, Terry LN, Hegedus EJ. Prevention of Lower Extremity Injuries in Basketball: A Systematic Review and Meta-Analysis. Sports Health. 2015 Sep-Oct;7(5):392-8. doi: 10.1177/1941738115593441. Epub 2015 Jun 26.
PubMed 26502412Mendez-Rebolledo G, Guzman-Munoz E, Gatica-Rojas V, Zbinden-Foncea H. Longer reaction time of the fibularis longus muscle and reduced postural control in basketball players with functional ankle instability: A pilot study. Phys Ther Sport. 2015 Aug;16(3):242-7. doi: 10.1016/j.ptsp.2014.10.008. Epub 2014 Nov 7.
PubMed 25869423Kim KM, Hart JM, Saliba SA, Hertel J. Modulation of the Fibularis Longus Hoffmann Reflex and Postural Instability Associated With Chronic Ankle Instability. J Athl Train. 2016 Aug;51(8):637-643. doi: 10.4085/1062-6050-51.10.05. Epub 2016 Sep 1.
PubMed 27583692Asadi A, Saez de Villarreal E, Arazi H. The Effects of Plyometric Type Neuromuscular Training on Postural Control Performance of Male Team Basketball Players. J Strength Cond Res. 2015 Jul;29(7):1870-5. doi: 10.1519/JSC.0000000000000832.
PubMed 25563677Benis R, Bonato M, La Torre A. Elite Female Basketball Players' Body-Weight Neuromuscular Training and Performance on the Y-Balance Test. J Athl Train. 2016 Sep;51(9):688-695. doi: 10.4085/1062-6050-51.12.03. Epub 2016 Nov 8.
PubMed 27824252Eils E, Schroter R, Schroder M, Gerss J, Rosenbaum D. Multistation proprioceptive exercise program prevents ankle injuries in basketball. Med Sci Sports Exerc. 2010 Nov;42(11):2098-105. doi: 10.1249/MSS.0b013e3181e03667.
PubMed 20386339Hurd WJ, Chmielewski TL, Snyder-Mackler L. Perturbation-enhanced neuromuscular training alters muscle activity in female athletes. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):60-9. doi: 10.1007/s00167-005-0624-y. Epub 2005 Jun 4.
PubMed 15937713
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuromuscular Training on Peroneal Eccentric Strength, Fatigue and Functional Performance in Young Women Basketball Players
- ClinicalTrials.gov ID
- NCT05594628
- Acronym / sponsor ID
- 1108799
- Conditions
- Healthy Young Women, Basketball Players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 26 Oct 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 the literature neuromuscular exercise programs are often used for prevention in sport players. Literature lacks of perturbation exercises and its effects on peroneal's muscle strength, fatigue and individual's performance parameters. This study will investigate if it is possible to achieve improvements on peroneal eccentric strength, fatigue, dynamic balance and individual's performance with the exercises mainly based on side perturbations.
Detailed description
Chronic ankle instability is very common in adolescent female basketball players. In the literature neuromuscular exercise programs are often used for prevention in sport players that usually contains of strength and/or balance exercises. Perturbation exercises are oftenly used in sport players for returning the sport or prevention but literature lacks of its effects statistically. This study will investigate if it is possible to achieve improvements on peroneal eccentric strength, fatigue, dynamic balance and individual's performance with the exercises mainly based on side perturbations. Strength and fatigue evaluations will be made with Cybex dynanometer. Dynamic balance evaluations will be made with Y-Balance Tests. Individual's performance parameter evaluations will be made with vertical jump test, cross jump test and side hop test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After first evaluation groups are randomly assigned to 2 groups. Both groups keep attending basketball trainings. One group is just going to keep attending basketball trainings, one group is going to keep attending usual basketball trainings and going to receive neuromuscular training that will be added in warming up exercises
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training+Basketball training | Experimental | Other: Neuromuscular trainingAfter all participiants are evaluated, they will be divided randomly to two groups, which one group will be taking neuromuscular training+usual basketball training |
| Control group(Basketball training) | No intervention | –After all participiants are evaluated, they will be divided randomly to two groups, which one group will be taking just the usual basketball training and not any extra interventions. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy, non-injured within the 6 months female basketball players that are willing to join the research
Key exclusion criteria (1 listed)
- That has a injury within 6 months with missing trainings at least 2 times in a row or having vestibuler dysfunction
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 |
|---|---|---|
| Neuromuscular trainingNeuromuscular training is designed as 8 weeks and 2 times a week, and approximately 20 minutes per session for Neuromuscular training+usual basketball training group. Other group is only going to keep attending usual basketball training. Neuromuscular training consisted 3 exercises: First exercise is passing the ball to side to side on bosu with standing on one leg. 60-90 seconds on time, 30-60 seconds off time. 2 sets for both passing sides and bilaterally. Second exercise is standing on bosu unilaterally and while standing stabilized, switching basketball hand to hand as dribbling on the floor. Exercise will be on for 60-90 seconds and off for 30-60 seconds, 2 sets for each side Third exercise is jumping with one stance/leg, and landing with double stance while a therabant is attached to the belly and pulling with a minimum/medium force from one side. Changing legs after one jump, 6 times for both side is equal to 1 set of the exercise. It will be done 2 sets for both sides. | Other | Neuromuscular Training+Basketball training |
Primary outcome
Changes in Peroneal eccentric strength
Time frame: 10 weeks
Force will be evaluated with Cybex Humac NORM, as Nm/kg(Newton-meters/kg). At 30° /s speed, 3 trials will be made with submaximal force for participants to understand the movement. After trials 4 maximal strength repetition will be made. Highest repetition, and average of 4 repetition will be used for analysis. Before and after the intervention evaluation will be made.
Changes in Peroneal endurance parameters
Time frame: 10 weeks
Endurance will be evaluated with Cybex Humac NORM, as Nm/kg(Newton-meters/kg). At 180° /s speed, 5 trials will be made with submaximal force for participants to understand the movement. After trials 20 maximal strength repetition will be made. Endurance is described as containing strength for a duration of time, it can be evaluted with Fatigue index/Endurance parameters will be evaluated with comparing last 10 repetion to first 10 repetion to assess the difference. Before and after the intervention evaluation will be made.
4 secondary outcomes
Changes in Dynamic Balance
Time frame: 10 weeks
Changes in Cross Hop Test
Time frame: 10 weeks
Changes in Vertical Jump Test
Time frame: 10 weeks
Changes in Side Hop Test
Time frame: 10 weeks
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 1 Sep 2023.
- Background: PubMed 19593416Gribble PA, Robinson RH. Alterations in knee kinematics and dynamic stability associated with chronic ankle instability. J Athl Train. 2009 Jul-Aug;44(4):350-5. doi: 10.4085/1062-6050-44.4.350.
- Background: PubMed 26502412Taylor JB, Ford KR, Nguyen AD, Terry LN, Hegedus EJ. Prevention of Lower Extremity Injuries in Basketball: A Systematic Review and Meta-Analysis. Sports Health. 2015 Sep-Oct;7(5):392-8. doi: 10.1177/1941738115593441. Epub 2015 Jun 26.
- Background: PubMed 25869423Mendez-Rebolledo G, Guzman-Munoz E, Gatica-Rojas V, Zbinden-Foncea H. Longer reaction time of the fibularis longus muscle and reduced postural control in basketball players with functional ankle instability: A pilot study. Phys Ther Sport. 2015 Aug;16(3):242-7. doi: 10.1016/j.ptsp.2014.10.008. Epub 2014 Nov 7.
- Background: PubMed 27583692Kim KM, Hart JM, Saliba SA, Hertel J. Modulation of the Fibularis Longus Hoffmann Reflex and Postural Instability Associated With Chronic Ankle Instability. J Athl Train. 2016 Aug;51(8):637-643. doi: 10.4085/1062-6050-51.10.05. Epub 2016 Sep 1.
- Background: PubMed 25563677Asadi A, Saez de Villarreal E, Arazi H. The Effects of Plyometric Type Neuromuscular Training on Postural Control Performance of Male Team Basketball Players. J Strength Cond Res. 2015 Jul;29(7):1870-5. doi: 10.1519/JSC.0000000000000832.
- Background: PubMed 27824252Benis R, Bonato M, La Torre A. Elite Female Basketball Players' Body-Weight Neuromuscular Training and Performance on the Y-Balance Test. J Athl Train. 2016 Sep;51(9):688-695. doi: 10.4085/1062-6050-51.12.03. Epub 2016 Nov 8.
- Background: PubMed 20386339Eils E, Schroter R, Schroder M, Gerss J, Rosenbaum D. Multistation proprioceptive exercise program prevents ankle injuries in basketball. Med Sci Sports Exerc. 2010 Nov;42(11):2098-105. doi: 10.1249/MSS.0b013e3181e03667.
- Background: PubMed 15937713Hurd WJ, Chmielewski TL, Snyder-Mackler L. Perturbation-enhanced neuromuscular training alters muscle activity in female athletes. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):60-9. doi: 10.1007/s00167-005-0624-y. Epub 2005 Jun 4.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training in people with Healthy Young Women and Basketball Players, run by Acibadem University at 2 sites 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 1 inclusion and 1 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Changes in Peroneal eccentric strength (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 NCT05594628, which also lists 8 linked publications.
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 1 Sep 2023.