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Clinical Trials/NCT04285619
NCT04285619
Withdrawn
Not Applicable

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.

Investigación en Hemofilia y Fisioterapia1 site in 1 countryMarch 1, 2020
ConditionsRunning

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Running
Sponsor
Investigación en Hemofilia y Fisioterapia
Locations
1
Primary Endpoint
Change from baseline dorsal ankle flexion after treatment and at month
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
June 10, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Investigación en Hemofilia y Fisioterapia
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change from baseline isometric force after treatment and at month(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(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(Screening visit, within the first seven days after treatment and after one month follow-up visit)

Study Sites (1)

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