Clinical trial NCT04285619: Physiotherapy Intervention With Flossing Conditioned by Verbal Suggestion About Ankle Functionality in Amateur Runners
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Running
Keywords: Amateur runners
Ankle dorsiflexion
Flossing
Expectancy
Randomized clinical trial
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2020-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline dorsal ankle flexion after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
measure: Change from baseline isometric force after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline elastic-explosive force after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
measure: Change from baseline stability after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
state: Comunity Of Madrid
Study officials:
References: