RunningNCT04285619
Physiotherapy Intervention With Flossing Conditioned by Verbal Suggestion About Ankle Functionality in Amateur Runners
A study testing Positive expectation and Neutral expectation in people with Running, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Limited ankle functionality is one of the main causes of runner injuries. The use of flossing techniques are used to improve functionality. The administration of an expectation can modulate corticospinal excitability, improving the therapeutic response. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Running
- What is being tested?
- Positive expectation and Neutral expectation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer amateur runners
- Both sexes
- Aged between 18 and 35 years
- That they practice a recreational career for a minimum of 2 days per week, with a duration of 60 minutes per session and an experience of 1 year in this sports field
- Obtain a score equal to or greater than 96 in the VISA-A questionnaire and at least 96% in the FAAM-Sp
Who cannot join
- Subjects who have suffered an injury to the lower limb in the last 6 months
- Have peripheral skin, vascular, muscle or nerve lesions, a history of cardiovascular or metabolic disease and coagulation problems at the time of the study
- That have been previously treated with flossing; who have taken antiinflammatory drugs in the last week
- Have not signed the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Physiotherapy Intervention With Flossing Conditioned by the Verbal Suggestion of an Expectation About Ankle Functionality in Amateur Runners. A Randomized Clinical Trial.
Limited ankle functionality is one of the main causes of runner injuries. The use of flossing techniques are used to improve functionality. The administration of an expectation can modulate corticospinal excitability, improving the therapeutic response.
The objective of the study is to evaluate the effect of inducing a positive expectation along with the application of flossing on the ankle functionality in healthy amateur runners.
Read more
Randomized clinical study, single blind, with follow-up period. 20 runners will be randomized to the two study groups: experimental (flossing technique with a positive expectation) and control (flossing technique with a neutral expectation). The study variables will be: dorsal ankle flexion (Weigh Bearing Lunge Test), isometric force in plantar ankle flexion (dynamometry), elastic-explosive force (Countermovement Jump) and stability (Y Balance Test). Using a Shapiro-Wilks analysis, the sample distribution will be calculated. The changes after each evaluation will be analyzed with the t-student test of related samples and through 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 expected to obtain changes in the variables between both groups and in the group / time interaction, which suggest an effect of the expectation on corticospinal excitability in healthy athletes.
- Conditions
- Running
- Being tested
- Positive expectation, Neutral expectation
- Keywords
- Amateur runners, Ankle dorsiflexion, Flossing, Expectancy, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive expectationOther
After heating, the physiotherapist will apply the bandage with flossing on both ankles, using 2 Voodoo Floss Bands (Power Guidance model). The distal to proximal bandage will begin with a tension of 50-70% and each lap of the bandage will cover 50% of the previous lap. There will be 3 figures of 8 that will cover the hindfoot and the distal third of the leg.
With the bandage applied on both feet, the runners will perform plantar flexion and active dorsal flexion movements in a range of complete joint movement with both ankles, at a constant rate of 2 seconds of plantar flexion, followed by another 2 of dorsal flexion, during A period of 2 minutes. Next, the therapist will remove the bandages and the athlete will walk barefoot for a minute, to restore normal blood flow.
During the first application of the bandage, the investigator will induce the positive expectation through a standardized phrase for all subjects
Neutral expectationOther
After heating, the physiotherapist will apply the bandage with flossing on both ankles, using 2 Voodoo Floss Bands (Power Guidance model). The distal to proximal bandage will begin with a tension of 50-70% and each lap of the bandage will cover 50% of the previous lap. There will be 3 figures of 8 that will cover the hindfoot and the distal third of the leg.
With the bandage applied on both feet, the runners will perform plantar flexion and active dorsal flexion movements in a range of complete joint movement with both ankles, at a constant rate of 2 seconds of plantar flexion, followed by another 2 of dorsal flexion, during A period of 2 minutes. Next, the therapist will remove the bandages and the athlete will walk barefoot for a minute, to restore normal blood flow.
During the first application of the bandage, the researcher will not induce any expectations to the athletes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each session will last 10 minutes and a weekly intervention will take place over 3 weeks. The intervention by flossing will be carried out following the application protocol described by the manufacturer for the application of flossing on the ankle. Before the intervention, participants will perform a standard warm-up: 10 minutes of exercise bike at a moderate intensity Receives: Other: Positive expectation |
| Control group | Active comparator | Each session will last 10 minutes and a weekly intervention will take place over 3 weeks. The intervention by flossing will be carried out following the application protocol described by the manufacturer for the application of flossing on the ankle. Before the intervention, participants will perform a standard warm-up: 10 minutes of exercise bike at a moderate intensity Receives: Other: Neutral expectation |
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 month
It will be assessed with the Weigh Bearing Lunge Test. The Dorsiflex iPhone application will be used. The subject will stand in stride position, with the dominant leg more advanced, to perform the measurement on it. Next, the evaluator will support the vertical and parallel iPhone on the tibia, so that the upper corner of the phone is in contact with the anterior tibial tuberosity and along the diaphysis. The investigator will give 5 seconds to achieve maximum dorsal ankle flexion, advancing the knee as far as possible without the heel detaching from the ground. Next, the same procedure will be performed on the contralateral member. This measurement will be performed 3 times, alternately on each ankle, with a 30-second wait interval, and the average of each ankle will be calculated to obtain the definitive value of the measurement (34). The unit of measure will be degrees with decimals.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (3)
Change from baseline isometric force after treatment and at month
This variable will be measured in Newtons (N), with a manual digital dynamometer (wireless microFET®2 model). The athlete will be placed supine with the knees extended and the ankles in plantar flexion relaxed. The dynamometer will be placed over the head of the metatarsals of the foot. The runner will be instructed to gradually increase his strength for 3 seconds and to make maximum force against the dynamometer for another 2 seconds only with his ankle withdrawing his foot quickly. The record will be repeated 3 times, with 30 seconds between repetitions, to avoid the effects of post-activation enhancement accrued from the realization of a maximum voluntary isometric force. The average of the 3 will be obtained to calculate the measurement value.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline elastic-explosive force after treatment and at month
It will be calculated with the Countermovement Jump test. The result is measured with the jump height in centimeters (cm) or the flight time in seconds (sg). We will measure the height of the jump (cm) with the MyJump application for iPhone. The runner will stand in standing position with feet apart at the height of the hips, straight legs and hands resting on the hips. The evaluator will focus the feet to record. The participant will be asked to jump as high as possible, without separating the hands from the hips, keeping the legs straight during the flight and landing simultaneously with both feet. Recording will pause and wait 30 seconds to repeat the jump. There will be 3 jumps in total and the average of them will be made to determine the final value in cm.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline stability after treatment and at month
The evaluation will be measured in centimeters using the Star Excursion Balance Test. This test consists of moving a moving part with the foot, in monopodal support, on 3 axes of movement, separated from each other 135º - 90º - 135º; anterior (0º), posteromedial (135º) and posterolateral (225º). The maximum possible distance must be reached before losing balance. During the test, you must move the object consecutively on each axis, without resting the other foot on the ground, until you travel the 3 strips. At this time, the test will end and the evaluator will measure the distance traveled. The subject will be urged to repeat the test again, up to a total of 3 times. Next, the same procedure will be performed with the contralateral member.
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 posted26 Feb 2020
- Study start1 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 RunningStudies 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
- NCT04285619
- Sponsor's protocol ID
- FLOSSINGRUN
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 5 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physiotherapy Intervention With Flossing Conditioned by the Verbal Suggestion of an Expectation About Ankle Functionality in Amateur Runners. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04285619
- Acronym / sponsor ID
- FLOSSINGRUN
- Conditions
- Running
- Keywords
- Amateur runners, Ankle dorsiflexion, Flossing, Expectancy, 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
- 1 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 26 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.
Limited ankle functionality is one of the main causes of runner injuries. The use of flossing techniques are used to improve functionality. The administration of an expectation can modulate corticospinal excitability, improving the therapeutic response.
The objective of the study is to evaluate the effect of inducing a positive expectation along with the application of flossing on the ankle functionality in healthy amateur runners.
Randomized clinical study, single blind, with follow-up period. 20 runners will be randomized to the two study groups: experimental (flossing technique with a positive expectation) and control (flossing technique with a neutral expectation). The study variables will be: dorsal ankle flexion (Weigh Bearing Lunge Test), isometric force in plantar ankle flexion (dynamometry), elastic-explosive force (Countermovement Jump) and stability (Y Balance Test). Using a Shapiro-Wilks analysis, the sample distribution will be calculated. The changes after each evaluation will be analyzed with the t-student test of related samples and through 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 expected to obtain changes in the variables between both groups and in the group / time interaction, which suggest an effect of the expectation on corticospinal excitability in healthy athletes.
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: Positive expectationEach session will last 10 minutes and a weekly intervention will take place over 3 weeks. The intervention by flossing will be carried out following the application protocol described by the manufacturer for the application of flossing on the ankle. Before the intervention, participants will perform a standard warm-up: 10 minutes of exercise bike at a moderate intensity |
| Control group | Active comparator | Other: Neutral expectationEach session will last 10 minutes and a weekly intervention will take place over 3 weeks. The intervention by flossing will be carried out following the application protocol described by the manufacturer for the application of flossing on the ankle. Before the intervention, participants will perform a standard warm-up: 10 minutes of exercise bike at a moderate intensity |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteer amateur runners
- Both sexes
- Aged between 18 and 35 years
- That they practice a recreational career for a minimum of 2 days per week, with a duration of 60 minutes per session and an experience of 1 year in this sports field
- Obtain a score equal to or greater than 96 in the VISA-A questionnaire and at least 96% in the FAAM-Sp
Key exclusion criteria (4 listed)
- Subjects who have suffered an injury to the lower limb in the last 6 months
- Have peripheral skin, vascular, muscle or nerve lesions, a history of cardiovascular or metabolic disease and coagulation problems at the time of the study
- That have been previously treated with flossing; who have taken antiinflammatory drugs in the last week
- 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 |
|---|---|---|
| Positive expectationAfter heating, the physiotherapist will apply the bandage with flossing on both ankles, using 2 Voodoo Floss Bands (Power Guidance model). The distal to proximal bandage will begin with a tension of 50-70% and each lap of the bandage will cover 50% of the previous lap. There will be 3 figures of 8 that will cover the hindfoot and the distal third of the leg. With the bandage applied on both feet, the runners will perform plantar flexion and active dorsal flexion movements in a range of complete joint movement with both ankles, at a constant rate of 2 seconds of plantar flexion, followed by another 2 of dorsal flexion, during A period of 2 minutes. Next, the therapist will remove the bandages and the athlete will walk barefoot for a minute, to restore normal blood flow. During the first application of the bandage, the investigator will induce the positive expectation through a standardized phrase for all subjects | Other | Experimental group |
| Neutral expectationAfter heating, the physiotherapist will apply the bandage with flossing on both ankles, using 2 Voodoo Floss Bands (Power Guidance model). The distal to proximal bandage will begin with a tension of 50-70% and each lap of the bandage will cover 50% of the previous lap. There will be 3 figures of 8 that will cover the hindfoot and the distal third of the leg. With the bandage applied on both feet, the runners will perform plantar flexion and active dorsal flexion movements in a range of complete joint movement with both ankles, at a constant rate of 2 seconds of plantar flexion, followed by another 2 of dorsal flexion, during A period of 2 minutes. Next, the therapist will remove the bandages and the athlete will walk barefoot for a minute, to restore normal blood flow. During the first application of the bandage, the researcher will not induce any expectations to the athletes. | Other | Control group |
Primary outcome
Change from baseline dorsal ankle 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 will be assessed with the Weigh Bearing Lunge Test. The Dorsiflex iPhone application will be used. The subject will stand in stride position, with the dominant leg more advanced, to perform the measurement on it. Next, the evaluator will support the vertical and parallel iPhone on the tibia, so that the upper corner of the phone is in contact with the anterior tibial tuberosity and along the diaphysis. The investigator will give 5 seconds to achieve maximum dorsal ankle flexion, advancing the knee as far as possible without the heel detaching from the ground. Next, the same procedure will be performed on the contralateral member. This measurement will be performed 3 times, alternately on each ankle, with a 30-second wait interval, and the average of each ankle will be calculated to obtain the definitive value of the measurement (34). The unit of measure will be degrees with decimals.
3 secondary outcomes
Change from baseline isometric force after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline elastic-explosive force after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline stability 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 5 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 Positive expectation and Neutral expectation in people with Running, 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 5 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 dorsal ankle 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 5 Sep 2021.