Weight, BodyNCT03867279
Flossing Technique With Neuromuscular Reeducation Exercises in Trained Subjects
A study testing Flossing and Reeducation exercises in people with Weight, Body, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction. A deficit of dorsiflexion and motor control can limit the performance of a squat. Neuromuscular reeducation exercises, mobility and elasticity are used in the neuromuscular control and mobility of the kinetic chain. The Flossing technique is applied to improve ankle mobility and the perception of effort. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight, Body
- What is being tested?
- Flossing and Reeducation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 1 Jul 2019
- 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 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18 to 24 years old
- Male
- That they be weight lifters with at least one year of experience
- That they do not present musculoskeletal injury or pathology in the three months prior to the beginning of the study
Who cannot join
- Can not be present during the 6 weeks of the intervention and the evaluations will be excluded
- Under pharmacological treatment
- Who are performing another physiotherapy study
- Not sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flossing Technique Together With a Protocol of Neuromuscular Reeducation Exercises in the Improvement of Dorsiflexion of the Ankle and the Perception of Effort When Performing a Squat in Trained Subjects. A Randomized Clinical Trial.
Introduction. A deficit of dorsiflexion and motor control can limit the performance of a squat. Neuromuscular reeducation exercises, mobility and elasticity are used in the neuromuscular control and mobility of the kinetic chain. The Flossing technique is applied to improve ankle mobility and the perception of effort.
Objective. To compare the efficacy of a protocol for neuromuscular reeducation exercises, mobility and elasticity, and the Flossing technique in ankle mobility and perception of effort when performing squats.
Read more
Study design. Randomized, multicenter, single-blind clinical study with a follow-up period.
Methodology. 40 weightlifters included in the study will be assigned randomly to the study groups: experimental (protocol of reeducation exercises plus the application of the Flossing technique) and control (protocol of reeducation exercises). The intervention will last 4 weeks, with two weekly sessions of 15 minutes each. The variables of the study will be the range of movement of ankle dorsiflexion (Weight Bearing Lunge Test) and the perception of the effort during the squat (Borg scale). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. The distribution of the sample will be analyzed using the Kolmogorov-Smirnof test. In case of homogeneity, parametric tests will be used to calculate changes after each evaluation (t-student) and the intra- and intersubject effect (repeated measures ANOVA).
Expected results. Improvement in dorsiflexion of the ankle and decrease in the perception of effort during the squat.
- Conditions
- Weight, Body
- Being tested
- Flossing, Reeducation exercises
- Keywords
- Weightlifters, Flossbands, Clinical Trial, Physical Therapy, Squat
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlossingOther
The reeducation exercises are: lunge and hold (the subject performs a lunge increasing the dorsiflexion of the ankle, advancing the tibia as much as possible without taking off the heel of the floor and without valgus of the knee, 15 repetition of 10 seconds of duration each); back squat (squat with a pike supported on scapulae); and chaturanga (from the prone position with extension of elbows and spine, the subject raises upper antero iliac spines performing a shoulder flexion and raising the pelvis to the ceiling maintaining the hip flexion and knees extended and keeping the heels touching the ground. The subjects included in this group will perform the exercises while a compression band is applied to the ankle.
Reeducation exercisesOther
The reeducation exercises are: lunge and hold (the subject performs a lunge increasing the dorsiflexion of the ankle, advancing the tibia as much as possible without taking off the heel of the floor and without valgus of the knee, 15 repetition of 10 seconds of duration each); back squat (squat with a pike supported on scapulae); and chaturanga (from the prone position with extension of elbows and spine, the subject raises upper antero iliac spines performing a shoulder flexion and raising the pelvis to the ceiling maintaining the hip flexion and knees extended and keeping the heels touching the ground.
| Study group | Role | What they receive |
|---|---|---|
| Flossing | Experimental | The subjects included in this group will perform a protocol of reeducation exercises plus the application of the Flossing technique. The intervention will last 4 weeks, with two weekly sessions of 15 minutes each Receives: Other: Flossing |
| Reeducation exercises | Active comparator | The subjects included in this group will carry out a protocol of reeducation exercises. The intervention will last 4 weeks, with two weekly sessions of 15 minutes each Receives: Other: Reeducation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline dorsal ankle flexion after treatment and at a month
The dorsal ankle flexion will be measured with the Weight-bearing lunge test. The subject will stand in front of a wall, using a tape measure that goes from the wall to the first toe. The subject will perform the greatest dorsiflexion of the ankle that allows him to touch the wall without lifting the ankle. The greater distance that this objective achieves will be the reference value. The unit of measurement of this test is the centimeter, indicating a higher score a greater range of ankle movement in dorsiflexion.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (1)
Change from baseline level of effort perceived after treatment and at a month
The level of effort will be measured with the modified Borg scale. With this test, the level of effort perceived by the athlete when performing the gesture of the squat will be measured. With the subject standing you will be asked to perform a squat, asking him to indicate on the scale what his level of effort has been. This scale has a range of 0 to 10 points (where 0 indicates the minimum degree of effort, and 10 the maximum effort referred by the subject).
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 posted7 Mar 2019
- Study start12 Mar 2019
- Primary completion15 Apr 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight, BodyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867279
- Sponsor's protocol ID
- FLOSSING
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2019
- Last updated
- 27 Jan 2020
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flossing Technique Together With a Protocol of Neuromuscular Reeducation Exercises in the Improvement of Dorsiflexion of the Ankle and the Perception of Effort When Performing a Squat in Trained Subjects. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03867279
- Acronym / sponsor ID
- FLOSSING
- Conditions
- Weight, Body
- Keywords
- Weightlifters, Flossbands, Clinical Trial, Physical Therapy, Squat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 7 Mar 2019 (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.
Introduction. A deficit of dorsiflexion and motor control can limit the performance of a squat. Neuromuscular reeducation exercises, mobility and elasticity are used in the neuromuscular control and mobility of the kinetic chain. The Flossing technique is applied to improve ankle mobility and the perception of effort.
Objective. To compare the efficacy of a protocol for neuromuscular reeducation exercises, mobility and elasticity, and the Flossing technique in ankle mobility and perception of effort when performing squats.
Study design. Randomized, multicenter, single-blind clinical study with a follow-up period.
Methodology. 40 weightlifters included in the study will be assigned randomly to the study groups: experimental (protocol of reeducation exercises plus the application of the Flossing technique) and control (protocol of reeducation exercises). The intervention will last 4 weeks, with two weekly sessions of 15 minutes each. The variables of the study will be the range of movement of ankle dorsiflexion (Weight Bearing Lunge Test) and the perception of the effort during the squat (Borg scale). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. The distribution of the sample will be analyzed using the Kolmogorov-Smirnof test. In case of homogeneity, parametric tests will be used to calculate changes after each evaluation (t-student) and the intra- and intersubject effect (repeated measures ANOVA).
Expected results. Improvement in dorsiflexion of the ankle and decrease in the perception of effort during the squat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flossing | Experimental | Other: FlossingThe subjects included in this group will perform a protocol of reeducation exercises plus the application of the Flossing technique. The intervention will last 4 weeks, with two weekly sessions of 15 minutes each |
| Reeducation exercises | Active comparator | Other: Reeducation exercisesThe subjects included in this group will carry out a protocol of reeducation exercises. The intervention will last 4 weeks, with two weekly sessions of 15 minutes each |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- From 18 to 24 years old
- Male
- That they be weight lifters with at least one year of experience
- That they do not present musculoskeletal injury or pathology in the three months prior to the beginning of the study
Key exclusion criteria (4 listed)
- Can not be present during the 6 weeks of the intervention and the evaluations will be excluded
- Under pharmacological treatment
- Who are performing another physiotherapy study
- Not sign the informed consent document.
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 |
|---|---|---|
| FlossingThe reeducation exercises are: lunge and hold (the subject performs a lunge increasing the dorsiflexion of the ankle, advancing the tibia as much as possible without taking off the heel of the floor and without valgus of the knee, 15 repetition of 10 seconds of duration each); back squat (squat with a pike supported on scapulae); and chaturanga (from the prone position with extension of elbows and spine, the subject raises upper antero iliac spines performing a shoulder flexion and raising the pelvis to the ceiling maintaining the hip flexion and knees extended and keeping the heels touching the ground. The subjects included in this group will perform the exercises while a compression band is applied to the ankle. | Other | Flossing |
| Reeducation exercisesThe reeducation exercises are: lunge and hold (the subject performs a lunge increasing the dorsiflexion of the ankle, advancing the tibia as much as possible without taking off the heel of the floor and without valgus of the knee, 15 repetition of 10 seconds of duration each); back squat (squat with a pike supported on scapulae); and chaturanga (from the prone position with extension of elbows and spine, the subject raises upper antero iliac spines performing a shoulder flexion and raising the pelvis to the ceiling maintaining the hip flexion and knees extended and keeping the heels touching the ground. | Other | Reeducation exercises |
Primary outcome
Change from baseline dorsal ankle flexion after treatment and at a month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The dorsal ankle flexion will be measured with the Weight-bearing lunge test. The subject will stand in front of a wall, using a tape measure that goes from the wall to the first toe. The subject will perform the greatest dorsiflexion of the ankle that allows him to touch the wall without lifting the ankle. The greater distance that this objective achieves will be the reference value. The unit of measurement of this test is the centimeter, indicating a higher score a greater range of ankle movement in dorsiflexion.
1 secondary outcome
Change from baseline level of effort perceived after treatment and at a month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 27 Jan 2020.
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flossing and Reeducation exercises in people with Weight, Body, 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 4 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: finished, as of the sponsor's last update on 27 Jan 2020. 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 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?
Change from baseline dorsal ankle flexion after treatment and at a 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 27 Jan 2020.