search
Back to results

Flossing Protocol and Manual Therapy in Young Subjects With Recurrent Ankle Sprains

Primary Purpose

Young People

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Young People

Eligibility Criteria

18 Years - 22 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Young people between 18 and 22 years old Who have suffered a previous sprain No chronic or degenerative musculoskeletal pathologies of the ankle or knee That they do physical activity regularly. Exclusion Criteria: Have suffered a sprain in the last 6 months Being receiving another physiotherapy treatment at the time of the study Not signing the informed consent document.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    The intervention consists of the application of a treatment protocol based on an initial active warm-up consisting of 3 active exercises, walking for 1 minute performing slow and controlled movement of the ankle, raising the heels, 15 repetitions, dorsiflexion of the ankle in the standing position. gentleman, 15 reps. Subsequently, the floss band will be placed, performing again the 3 active warm-up exercises with the band on. After this, the passive manual techniques will be carried out for the remaining time, removing the flossing at the end of the latter, and actively mobilizing again.

    The subjects included in the control group will perform the same procedures, but placing the flossing without tension and performing the Kaltenborn manual techniques without sliding and without joint mobilization.

    Outcomes

    Primary Outcome Measures

    Change from baseline ankle range of motion after treatment and at 4 weeks
    Using an analog goniometer, range of motion was measured. This instrument has shown excellent reliability. The joint range in plantar and dorsiflexion was measured. The unit of measurement is degrees (the higher the degree, the greater the mobility).

    Secondary Outcome Measures

    Change from baseline pressure pain threshold treatment and at 4 weeks
    Pressure pain threshold will be measured with a pressure algometer (Wagner FDIX model, Wagner Instruments, CT, USA). Pressure will be progressively applied until the sensation begins to be painful. Pressure pain threshold will be measured bilaterally in the region ventral to the lateral malleolus.
    Change from baseline foot and ankle stability after treatment and at 4 weeks
    The biomechanical analysis of gait and balance will be evaluated using an Rs Scan® pressure platform and a FootScan® pressure measurement system. This scientific version biomechanical examination device measures plantar pressure using an X-Y array of resistive pressure sensitive sensors that are sequentially scanned. The system records pressure data when the subject is standing or walking on the platform. The measurements will be made with the basic platform of 0.5m with 4096 sensors with resistive technology and 300Hz data acquisition frequency. The biomechanics of gait will be analyzed with the analysis of the probes and the static balance in a time of 30 seconds.

    Full Information

    First Posted
    May 5, 2023
    Last Updated
    May 15, 2023
    Sponsor
    Universidad Católica San Antonio de Murcia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05859256
    Brief Title
    Flossing Protocol and Manual Therapy in Young Subjects With Recurrent Ankle Sprains
    Official Title
    Efficacy of a Flossing Protocol and Manual Therapy in the Clinical and Functional Improvement of Young Subjects With Recurrent Ankle Sprains. A Randomized Clinical Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 6, 2023 (Anticipated)
    Primary Completion Date
    June 3, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Católica San Antonio de Murcia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The most frequent lateral ankle sprain mechanism consists of talocrural plantarflexion added to a subtalar inversion. The anterior talofibular ligament, in plantar flexion, suffers maximum stress, being very sensitive to injury mechanisms with inversion of the foot, being the cause of up to 70% of sprains. The risk of injury recurrence must be taken into account. In sports practice, this percentage of recurrence is especially relevant. Randomized clinical study. Participants will be randomized to a control or experimental group. The dependent variable will be the range of motion in ankle dorsiflexion. Secondary variables will be pressure pain threshold, and stability of the foot and ankle. Three evaluations will be carried out: before the start of the study (T0), after the intervention (T1) and after a 4-week follow-up period (T2). All evaluations will be performed by one evaluator, blinded to player assignment The intervention consists of the application of a treatment protocol based on an initial active warm-up consisting of 3 active exercises, walking for 1 minute performing slow and controlled movement of the ankle, raising the heels, 15 repetitions, dorsiflexion of the ankle in the standing position. gentleman, 15 reps. Subsequently, the floss band will be placed, performing again the 3 active warm-up exercises with the band on. After this, the passive manual techniques will be carried out for the remaining time, removing the flossing at the end of the latter, and actively mobilizing again.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Young People

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    All evaluations will be carried out by one evaluator, blinded to the study conditions and the assignment of the players to the two study groups. In the subjects included in the control group, the same procedures will be carried out, but placing the flossing without tension and performing the Kaltenborn manual techniques without slipping and without joint mobilization.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    The intervention consists of the application of a treatment protocol based on an initial active warm-up consisting of 3 active exercises, walking for 1 minute performing slow and controlled movement of the ankle, raising the heels, 15 repetitions, dorsiflexion of the ankle in the standing position. gentleman, 15 reps. Subsequently, the floss band will be placed, performing again the 3 active warm-up exercises with the band on. After this, the passive manual techniques will be carried out for the remaining time, removing the flossing at the end of the latter, and actively mobilizing again.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    The subjects included in the control group will perform the same procedures, but placing the flossing without tension and performing the Kaltenborn manual techniques without sliding and without joint mobilization.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental
    Intervention Description
    The intervention consists of the application of a treatment protocol based on an initial active warm-up consisting of 3 active exercises, walking for 1 minute performing slow and controlled movement of the ankle, raising the heels, 15 repetitions, dorsiflexion of the ankle in the standing position. gentleman, 15 reps. Subsequently, the floss band will be placed, performing again the 3 active warm-up exercises with the band on. After this, the passive manual techniques will be carried out for the remaining time, removing the flossing at the end of the latter, and actively mobilizing again.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    The same procedures will be carried out, but placing the flossing without tension and performing the Kaltenborn manual techniques without sliding and without joint mobilization.
    Primary Outcome Measure Information:
    Title
    Change from baseline ankle range of motion after treatment and at 4 weeks
    Description
    Using an analog goniometer, range of motion was measured. This instrument has shown excellent reliability. The joint range in plantar and dorsiflexion was measured. The unit of measurement is degrees (the higher the degree, the greater the mobility).
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Change from baseline pressure pain threshold treatment and at 4 weeks
    Description
    Pressure pain threshold will be measured with a pressure algometer (Wagner FDIX model, Wagner Instruments, CT, USA). Pressure will be progressively applied until the sensation begins to be painful. Pressure pain threshold will be measured bilaterally in the region ventral to the lateral malleolus.
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up
    Title
    Change from baseline foot and ankle stability after treatment and at 4 weeks
    Description
    The biomechanical analysis of gait and balance will be evaluated using an Rs Scan® pressure platform and a FootScan® pressure measurement system. This scientific version biomechanical examination device measures plantar pressure using an X-Y array of resistive pressure sensitive sensors that are sequentially scanned. The system records pressure data when the subject is standing or walking on the platform. The measurements will be made with the basic platform of 0.5m with 4096 sensors with resistive technology and 300Hz data acquisition frequency. The biomechanics of gait will be analyzed with the analysis of the probes and the static balance in a time of 30 seconds.
    Time Frame
    Screening visit, within the first seven days after treatment and after four weeks follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Young people between 18 and 22 years old Who have suffered a previous sprain No chronic or degenerative musculoskeletal pathologies of the ankle or knee That they do physical activity regularly. Exclusion Criteria: Have suffered a sprain in the last 6 months Being receiving another physiotherapy treatment at the time of the study Not signing the informed consent document.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rubén Cuesta-Barriuso, PhD
    Phone
    0034985103386
    Email
    ruben.cuestab@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rubén Cuesta-Barriuso, PhD
    Organizational Affiliation
    Universidad de Oviedo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Flossing Protocol and Manual Therapy in Young Subjects With Recurrent Ankle Sprains

    We'll reach out to this number within 24 hrs