Ankle InjuriesNCT02739308
Effects of Proprioceptive Training on Neurofunctional Control and Ankle Sprains Incidence
A study testing Proprioceptive Training in people with Ankle Injuries, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The aim of this study is to investigate the influence of a 12-week proprioceptive training program on the neurofunctional control and the incidence of ankle sprains in fencing athletes. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Proprioceptive Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Apr 2016
- 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- practicing fencing at least a year
- have between 14 and 30 years.
Who cannot join
- be in physical therapy or participating in prevention programs
- have damage to lower limbs that compromise the tests
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Gabriela Souza de Vasconcelos
Porto Alegre, Rio Grande do Sul, 90160181
Gabriela Vasconcelos, Student, 555195372276, gabih-vasconcelos@hotmail.com
Claúdia Lima, Dr, 555199964747, claudia.lima@ufrgs.br
About this study
Official title: Effects of Proprioceptive Training on Neurofunctional Control and Ankle Sprains Incidence in Fencers: a Randomized Controlled Trial
The aim of this study is to investigate the influence of a 12-week proprioceptive training program on the neurofunctional control and the incidence of ankle sprains in fencing athletes. The study will be developed in six stages: familiarization, pre intervention, intervention, post intervention follow-up of three and six months. In the pre intervention stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12 weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of three to six months will be held the same pre intervention of the tests and recording the incidence of injuries occurred during the study. The expected result at the end of the study is to improve all variables, increasing the performance of athletes and decreasing the incidence of ankle sprains.
Read the detailed description
Fencing is an agility sport, with higher incidence of injuries in the lower limbs, with the ankle sprain the most prevalent. Injury prevention is very important to improve performance and reduce time off of athletes. Proprioceptive training programs can be added to the training of athletes, since in addition to the easy application and low cost, proprioception serves to stabilize the joint, preventing injuries. Therefore the aim of this study is to investigate the influence of a 12-week proprioceptive training program on the neurofunctional control and the incidence of ankle sprains in fencing athletes. The study will be a randomized clinical trial, with fencing athletes from 14 to 25, a multi-sport club of Porto Alegre/RS, and developed in six stages: familiarization, pre intervention, intervention, post intervention follow-up of three and six months. The first step will be to familiarize themselves with the force of testing and registration of injuries in the previous year. In the pre intervention stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12 weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of three to six months will be held the same pre intervention of the tests and recording the incidence of injuries occurred during the study. For statistical analysis, the data will be presented as mean and standard deviation and submitted to the Shapiro-Wilk test, ANOVA will be held for repeated measures and post hoc Bonferroni to determine differences. The effect size is calculated using Cohen's d test.o significance level is 0.05. The expected result at the end of the study is to improve all variables, increasing the performance of athletes and decreasing the incidence of ankle sprains.
- Conditions
- Ankle Injuries
- Being tested
- Proprioceptive Training, Control Group
- Keywords
- proprioception, ankle sprain, fencing
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive TrainingOther
In this study the training program will be developed for 12 weeks and will be applied during the heating of the athletes , three times a week and the duration of each session is 30 minutes. Each week will be chosen three of the 14 exercises adapted for fencing athletes , and preferably one of each category.
Control GroupOther
The control group will not make the intervention and will continue with usual training fencing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Proprioceptive Training | Experimental | The intervention will be the implementation of a proprioceptive training program for the fencing athletes in the intervention group.
In this study the training program will be developed for 12 weeks and will be applied during the heating of the athletes, three times a week and the duration of each session is 30 minutes. Each week will be chosen three of the 14 exercises adapted for fencing athletes, and preferably one of each category. The categories have exercises with different levels of difficulty and can change the exercises occur by different proposed levels or the complexity of the exercise by changing category. The training program will be implemented by the same evaluator over the 12 weeks. Receives: Other: Proprioceptive Training |
| Control | Placebo comparator | The control group will not make the intervention and will continue with the usual training fencing. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset muscle
The muscular reaction time will be assessed by electromyography during Lunge Test.
Measured: 12 weeks
Secondary outcomes (5)
Muscle Strength
The muscle strength of ankle will be assessed by isokinetic dynamometer.
Measured: 12 weeks
Star Excursion Balance Test (SEBT)
The SEBT will be used to measure the dynamic neuromuscular control.
Measured: 12 weeks
Drop Vertical Jump Test (DVJT)
The DVJT be used to assess the height of the heels, from surfaces 30, 40 and 50cm .
Measured: 12 weeks
Cumberland Ankle Instability Tools (CAIT)
The CAIT will be used to assess whether the ankle has istabilidade
Measured: 12 weeks
Injury questionnaire
This questionnaire will be used to assess the number of injuries and to joints they occurred.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2016
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Souza de Vasconcelos, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739308
- Sponsor's protocol ID
- 436620
- Status last verified
- Apr 2016
- First submitted
- 6 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Training on Neurofunctional Control and Ankle Sprains Incidence in Fencers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02739308
- Acronym / sponsor ID
- 436620
- Conditions
- Ankle Injuries
- Keywords
- proprioception, ankle sprain, fencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- 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.
The aim of this study is to investigate the influence of a 12-week proprioceptive training program on the neurofunctional control and the incidence of ankle sprains in fencing athletes. The study will be developed in six stages: familiarization, pre intervention, intervention, post intervention follow-up of three and six months. In the pre intervention stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12 weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of three to six months will be held the same pre intervention of the tests and recording the incidence of injuries occurred during the study. The expected result at the end of the study is to improve all variables, increasing the performance of athletes and decreasing the incidence of ankle sprains.
Detailed description
Fencing is an agility sport, with higher incidence of injuries in the lower limbs, with the ankle sprain the most prevalent. Injury prevention is very important to improve performance and reduce time off of athletes. Proprioceptive training programs can be added to the training of athletes, since in addition to the easy application and low cost, proprioception serves to stabilize the joint, preventing injuries. Therefore the aim of this study is to investigate the influence of a 12-week proprioceptive training program on the neurofunctional control and the incidence of ankle sprains in fencing athletes. The study will be a randomized clinical trial, with fencing athletes from 14 to 25, a multi-sport club of Porto Alegre/RS, and developed in six stages: familiarization, pre intervention, intervention, post intervention follow-up of three and six months. The first step will be to familiarize themselves with the force of testing and registration of injuries in the previous year. In the pre intervention stage will evaluate muscle strength inverters, everter, dorsal plantar flexors and ankle flexors through the isokinetic dynamometer; the reaction time of these muscles during Lunge Test; neuromuscular control during the Star Excursion Balance Test and performance in Drop Vertical Jump Test. In the intervention athletes will perform proprioceptive training for 12 weeks, three times a week, lasting 30 minutes. In the post intervention, the follow up of three to six months will be held the same pre intervention of the tests and recording the incidence of injuries occurred during the study. For statistical analysis, the data will be presented as mean and standard deviation and submitted to the Shapiro-Wilk test, ANOVA will be held for repeated measures and post hoc Bonferroni to determine differences. The effect size is calculated using Cohen's d test.o significance level is 0.05. The expected result at the end of the study is to improve all variables, increasing the performance of athletes and decreasing the incidence of ankle sprains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Proprioceptive Training | Experimental | Other: Proprioceptive TrainingThe intervention will be the implementation of a proprioceptive training program for the fencing athletes in the intervention group. In this study the training program will be developed for 12 weeks and will be applied during the heating of the athletes, three times a week and the duration of each session is 30 minutes. Each week will be chosen three of the 14 exercises adapted for fencing athletes, and preferably one of each category. The categories have exercises with different levels of difficulty and can change the exercises occur by different proposed levels or the complexity of the exercise by changing category. The training program will be implemented by the same evaluator over the 12 weeks. |
| Control | Placebo comparator | Other: Control GroupThe control group will not make the intervention and will continue with the usual training fencing. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- practicing fencing at least a year
- have between 14 and 30 years.
Key exclusion criteria (2 listed)
- be in physical therapy or participating in prevention programs
- have damage to lower limbs that compromise the tests
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 |
|---|---|---|
| Proprioceptive TrainingIn this study the training program will be developed for 12 weeks and will be applied during the heating of the athletes , three times a week and the duration of each session is 30 minutes. Each week will be chosen three of the 14 exercises adapted for fencing athletes , and preferably one of each category. | Other | Intervention: Proprioceptive Training |
| Control GroupThe control group will not make the intervention and will continue with usual training fencing. | Other | Control |
Primary outcome
Onset muscle
Time frame: 12 weeks
The muscular reaction time will be assessed by electromyography during Lunge Test.
5 secondary outcomes
Muscle Strength
Time frame: 12 weeks
Star Excursion Balance Test (SEBT)
Time frame: 12 weeks
Drop Vertical Jump Test (DVJT)
Time frame: 12 weeks
Cumberland Ankle Instability Tools (CAIT)
Time frame: 12 weeks
Injury questionnaire
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Training in people with Ankle Injuries, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2016. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset muscle (time frame: 12 weeks). 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 Apr 2016.