Physiotherapy Intervention With Flossing Conditioned by Verbal Suggestion About Ankle Functionality in Amateur Runners

NCT ID: NCT04285619

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-06-10

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.

Conditions

Running

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Positive expectation

Intervention Type: OTHER

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

Control group

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

Group Type: ACTIVE_COMPARATOR

Neutral expectation

Intervention Type: OTHER

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.

Interventions

Positive expectation

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

Intervention Type: OTHER

Neutral expectation

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Europea de Madrid

Madrid, Comunity of Madrid, Spain

Countries

Spain

Other Identifiers

FLOSSINGRUN

Identifier Type: -

Identifier Source: org_study_id