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

NCT04285619 | Withdrawn

• 1 other identifier: FLOSSINGRUN
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Amateur runners; Ankle dorsiflexion; Flossing; Expectancy; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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 Arms (2)

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

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

Other: Neutral expectation

Interventions

Positive expectation 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

Experimental group

Neutral expectation 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.

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 26, 2020
• Study Start: March 1, 2020
• Primary Completion: May 20, 2020
• Study Completion: June 10, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

ES (1)