Athlete FootNCT04289857
Neurodynamics to Improve Jump Functionality in Trampoline Jump Gymnasts
A study testing Neurodynamic training in people with Athlete Foot, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
The goal of neurodynamics is to restore homeostasis of peripheral nerves. In the current context there is varied evidence that links neurodynamics with clinical pain treatments or different pathologies, but little evidence regarding changes in the functionality of athletes, which could be related to improvements in… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athlete Foot
- What is being tested?
- Neurodynamic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 10 Jun 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Trampoline jumping gymnasts
- Male
- Aged between 18 and 30 years
- Who train at least 2 days a week
- Federated in the Madrid Gymnastics Federation
Who cannot join
- Subjects who have a medical diagnosis of musculoskeletal pathology at the time of beginning the study
- Neural pathology in the last 6 months
- With cognitive deficit that prevents them from understanding physical tests and questionnaires
- Have not signed the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Intervention by Means of Neurodynamic Technique to Improve the Functionality of the Jump in Trampoline Jump Gymnasts. A Randomized Clinical Study.
The goal of neurodynamics is to restore homeostasis of peripheral nerves. In the current context there is varied evidence that links neurodynamics with clinical pain treatments or different pathologies, but little evidence regarding changes in the functionality of athletes, which could be related to improvements in performance.
The main objective of the study is to determine if the neurodynamic technique is effective in increasing the range of hip mobility and in increasing the jump with counter movement.
Read more
Randomized, simple blind clinical study. 15 trampoline jumping gymnasts will be randomized to the two study groups: experimental (active sciatic neurodynamics techniques) and control (without intervention). The intervention will last 4 weeks, with 3 weekly sessions of approximately 5 minutes each. The study variables will be the range of hip flexion movement (goniometry) and the countermove jump (My Jump® application). A descriptive statistical analysis will be performed calculating the main statistical characteristics. The sample distribution will be calculated using a Shapiro-Wills analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
It is intended to observe improvement in the range of hip flexion movement and in the jump with countermovement.
- Conditions
- Athlete Foot
- Being tested
- Neurodynamic training
- Keywords
- Gymnastics trampoline, Neurodynamics, Jump, Range of motion, Randomized clinical trial
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic trainingOther
Starting from a sitting position on a stretcher, with dorsolumbar flexion, it is required to maintain that posture throughout the exercise. Sliding with the straight leg sitting consists of performing alternate movements. First, knee extension and dorsal ankle flexion will be performed, increasing neural tension, combined with cervical extension (to decrease neural tension) in the first instance. Subsequently, knee flexion and plantar ankle flexion (decreasing neural tension) combined with cervical flexion (increasing neural tension) will be performed. The dosage of the technique will be: two seconds for each movement, with 10 repetitions of each one. All sessions will be led by one of the group's researchers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each session will last a maximum of 5 minutes, taking place for 3 days a week, over a period of 4 weeks. The intervention will be performed at the start of training (before warm-up). Receives: Other: Neurodynamic training |
| Control group | No intervention | Athletes included in the control group will not perform any intervention, continuing with their usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hip flexion after treatment and at month
Using a universal goniometer. The subject will be placed supine on a stretcher, identifying the lateral condyle of the femur with a marker, as well as the head of the fibula and the fibular malleolus. The goniometer axis will be placed on the projection of the greater trochanter of the femur. One of the arms of the goniometer arms will be placed parallel to the table (checked with a level). The athlete will be asked for active hip flexion by keeping the knee and ankle in the extended position, being careful not to bend the knee, or swing the pelvis backwards and without turning the hip to external rotation. The other arm of the goniometer will be placed in the direction of the line between the head of the fibula and the fibular malleolus. The unit of measure is the degree, a numerical value whose normal range is 0º-120º
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (1)
Change from baseline jump height with counter movement after treatment and at month
It will be done with the My Jump application. The athlete will be placed in standing position, with the feet separated at shoulder height and will be asked to jump as high as possible with a rapid movement in countermovement. The hands will remain on the hips during the execution of the jump. The depth of the counter movement will be self-selected and gymnasts will be asked to land near the initial jump zone. They will be instructed verbally to jump as high as possible without specifying the angle of flexion of the knee during the countermovement phase. With the My Jump application, the athlete will be recorded performing the jump with counter movement and the application will determine the height of the jump. The unit of measure is centimeters, where the greater the distance, the greater the height.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start2 Mar 2020
- Primary completion20 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athlete FootStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289857
- Sponsor's protocol ID
- Neuro
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Intervention by Means of Neurodynamic Technique to Improve the Functionality of the Jump in Trampoline Jump Gymnasts. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04289857
- Acronym / sponsor ID
- Neuro
- Conditions
- Athlete Foot
- Keywords
- Gymnastics trampoline, Neurodynamics, Jump, Range of motion, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 28 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.
The goal of neurodynamics is to restore homeostasis of peripheral nerves. In the current context there is varied evidence that links neurodynamics with clinical pain treatments or different pathologies, but little evidence regarding changes in the functionality of athletes, which could be related to improvements in performance.
The main objective of the study is to determine if the neurodynamic technique is effective in increasing the range of hip mobility and in increasing the jump with counter movement.
Randomized, simple blind clinical study. 15 trampoline jumping gymnasts will be randomized to the two study groups: experimental (active sciatic neurodynamics techniques) and control (without intervention). The intervention will last 4 weeks, with 3 weekly sessions of approximately 5 minutes each. The study variables will be the range of hip flexion movement (goniometry) and the countermove jump (My Jump® application). A descriptive statistical analysis will be performed calculating the main statistical characteristics. The sample distribution will be calculated using a Shapiro-Wills analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
It is intended to observe improvement in the range of hip flexion movement and in the jump with countermovement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Neurodynamic trainingEach session will last a maximum of 5 minutes, taking place for 3 days a week, over a period of 4 weeks. The intervention will be performed at the start of training (before warm-up). |
| Control group | No intervention | –Athletes included in the control group will not perform any intervention, continuing with their usual routine. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Trampoline jumping gymnasts
- Male
- Aged between 18 and 30 years
- Who train at least 2 days a week
- Federated in the Madrid Gymnastics Federation
Key exclusion criteria (4 listed)
- Subjects who have a medical diagnosis of musculoskeletal pathology at the time of beginning the study
- Neural pathology in the last 6 months
- With cognitive deficit that prevents them from understanding physical tests and questionnaires
- Have not signed the informed consent
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 |
|---|---|---|
| Neurodynamic trainingStarting from a sitting position on a stretcher, with dorsolumbar flexion, it is required to maintain that posture throughout the exercise. Sliding with the straight leg sitting consists of performing alternate movements. First, knee extension and dorsal ankle flexion will be performed, increasing neural tension, combined with cervical extension (to decrease neural tension) in the first instance. Subsequently, knee flexion and plantar ankle flexion (decreasing neural tension) combined with cervical flexion (increasing neural tension) will be performed. The dosage of the technique will be: two seconds for each movement, with 10 repetitions of each one. All sessions will be led by one of the group's researchers. | Other | Experimental group |
Primary outcome
Change from baseline hip flexion after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Using a universal goniometer. The subject will be placed supine on a stretcher, identifying the lateral condyle of the femur with a marker, as well as the head of the fibula and the fibular malleolus. The goniometer axis will be placed on the projection of the greater trochanter of the femur. One of the arms of the goniometer arms will be placed parallel to the table (checked with a level). The athlete will be asked for active hip flexion by keeping the knee and ankle in the extended position, being careful not to bend the knee, or swing the pelvis backwards and without turning the hip to external rotation. The other arm of the goniometer will be placed in the direction of the line between the head of the fibula and the fibular malleolus. The unit of measure is the degree, a numerical value whose normal range is 0º-120º
1 secondary outcome
Change from baseline jump height with counter movement after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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?
A study testing Neurodynamic training in people with Athlete Foot, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Sep 2021. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline hip flexion after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 2 Sep 2021.