Ankle SprainNCT02097940
Influence of Sensorimotor Treatment in the Balance of Soccer
A study testing proprioceptive exercises in people with Ankle Sprain, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
This study presents the hypothesis that the sensory processing engine improves balance and agility for football athletes. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- proprioceptive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Mar 2014
- 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 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- minimum of three years of training in the sport,
- participating in state and national competitions,
- often training at least five times a week
Who cannot join
- athletes undergoing surgical procedures or have muscle and joint injuries in the lower limbs in the last three months,
- which are in physical therapy or who require the use of stabilizers to perform the tests on the platform or during the treatment protocol
Trial locations and contacts
1 site in 1 country.
About this study
This study presents the hypothesis that the sensory processing engine improves balance and agility for football athletes.
Read the detailed description
Objectives: To investigate the influence of the sensorimotor treatment in balance, agility and functionality soccer players assessed using force platform, functional tests and questionnaires.
Methods: This study was characterized as a randomized clinical trial. 20 male soccer players was assessed by means of questionnaires, force platform in one foot, and functional tests of balance and agility (Side Hop Test, Figure of Eight Hop Star Excursion Balance Test and Test). To the platform, the parameters of the center pressure (COP) in the anterior- posterior and medial -lateral directions was used for analysis, to functional tests the time-second performance was analyzed. Initially all athletes respond to the questionnaires, was evaluated on the force platform and through functional testing by blind evaluators. Following, they were randomized to treatment groups (n=10) and control (n=10). The treatment group performed 6 weeks of proprioceptive exercises with shifts and one-leg jumps and bipedal support.
The control group remained in soccer training. At the end of the treatment protocol and all were reassessed following the cross-over, where the control group performed the same treatment sensory motor was developed.
- Conditions
- Ankle Sprain
- Being tested
- proprioceptive exercises
- Keywords
- Postural balance, Athletes, Sports, Soccer, Physiotherapy
- 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 exercisesOther
Also called treatment
Exercises with movements, jumping and imbalance.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Active comparator | The treatment group performed of proprioceptive exercises with shifts and one-leg jumps. Receives: Other: proprioceptive exercises |
| control | No intervention | The control group remained in soccer training |
What is being measured
The primary outcome is the main question the study is designed to answer.
answers to survey
The athletes answered questionnaires with general data (age, weight, height, BMI, playing position)
Measured: up to one year
Secondary outcomes (1)
Variables center pressure swing
Evaluation of body balance on the force platform.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Macedo, Universidade Estadual de Londrina
- Investigators
- Christiane Macedo, doctor, Principal investigator, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097940
- Sponsor's protocol ID
- Christiane Macedo
- Status last verified
- Nov 2017
- First submitted
- 17 Mar 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Emery CA, Meeuwisse WH. The effectiveness of a neuromuscular prevention strategy to reduce injuries in youth soccer: a cluster-randomised controlled trial. Br J Sports Med. 2010 Jun;44(8):555-62. doi: 10.1136/bjsm.2010.074377.
PubMed 20547668Bizzini M, Junge A, Dvorak J. Implementation of the FIFA 11+ football warm up program: how to approach and convince the Football associations to invest in prevention. Br J Sports Med. 2013 Aug;47(12):803-6. doi: 10.1136/bjsports-2012-092124. Epub 2013 Jun 27.
PubMed 23813485
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sensorimotor Treatment in the Balance of Soccer
- ClinicalTrials.gov ID
- NCT02097940
- Acronym / sponsor ID
- Christiane Macedo
- Conditions
- Ankle Sprain
- Keywords
- Postural balance, Athletes, Sports, Soccer, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Mar 2014 (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.
This study presents the hypothesis that the sensory processing engine improves balance and agility for football athletes.
Detailed description
Objectives: To investigate the influence of the sensorimotor treatment in balance, agility and functionality soccer players assessed using force platform, functional tests and questionnaires.
Methods: This study was characterized as a randomized clinical trial. 20 male soccer players was assessed by means of questionnaires, force platform in one foot, and functional tests of balance and agility (Side Hop Test, Figure of Eight Hop Star Excursion Balance Test and Test). To the platform, the parameters of the center pressure (COP) in the anterior- posterior and medial -lateral directions was used for analysis, to functional tests the time-second performance was analyzed. Initially all athletes respond to the questionnaires, was evaluated on the force platform and through functional testing by blind evaluators. Following, they were randomized to treatment groups (n=10) and control (n=10). The treatment group performed 6 weeks of proprioceptive exercises with shifts and one-leg jumps and bipedal support.
The control group remained in soccer training. At the end of the treatment protocol and all were reassessed following the cross-over, where the control group performed the same treatment sensory motor was developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Active comparator | Other: proprioceptive exercisesThe treatment group performed of proprioceptive exercises with shifts and one-leg jumps. |
| control | No intervention | –The control group remained in soccer training |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- minimum of three years of training in the sport,
- participating in state and national competitions,
- often training at least five times a week
Key exclusion criteria (2 listed)
- athletes undergoing surgical procedures or have muscle and joint injuries in the lower limbs in the last three months,
- which are in physical therapy or who require the use of stabilizers to perform the tests on the platform or during the treatment protocol
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 exercisesAlso: treatmentExercises with movements, jumping and imbalance. | Other | treatment |
Primary outcome
answers to survey
Time frame: up to one year
The athletes answered questionnaires with general data (age, weight, height, BMI, playing position)
1 secondary outcome
Variables center pressure swing
Time frame: up to one year
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 29 Nov 2017.
- Results publication: PubMed 20547668Emery CA, Meeuwisse WH. The effectiveness of a neuromuscular prevention strategy to reduce injuries in youth soccer: a cluster-randomised controlled trial. Br J Sports Med. 2010 Jun;44(8):555-62. doi: 10.1136/bjsm.2010.074377.
- Results publication: PubMed 23813485Bizzini M, Junge A, Dvorak J. Implementation of the FIFA 11+ football warm up program: how to approach and convince the Football associations to invest in prevention. Br J Sports Med. 2013 Aug;47(12):803-6. doi: 10.1136/bjsports-2012-092124. Epub 2013 Jun 27.
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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.
Christiane Macedo, doctor principal investigator
State University of Londrina
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 exercises in people with Ankle Sprain, run by Universidade Estadual de Londrina 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 3 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: finished, as of the sponsor's last update on 29 Nov 2017. 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. 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?
answers to survey (time frame: up to one year). 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 NCT02097940, which also lists 2 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 29 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.