NCT05859256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 11, 2024

Status Verified

May 1, 2023

Enrollment Period

28 days

First QC Date

May 5, 2023

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Screening visit, within the first seven days after treatment and after four weeks follow-up

Secondary Outcomes (2)

  • Change from baseline pressure pain threshold treatment and at 4 weeks

    Screening visit, within the first seven days after treatment and after four weeks follow-up

  • Change from baseline foot and ankle stability after treatment and at 4 weeks

    Screening visit, within the first seven days after treatment and after four weeks follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Experimental

Control group

PLACEBO COMPARATOR

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.

Other: Control

Interventions

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.

Experimental group
ControlOTHER

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.

Control group

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, 30107, Spain

Location

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad de Oviedo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 15, 2023

Study Start

May 6, 2023

Primary Completion

June 3, 2023

Study Completion

July 1, 2023

Last Updated

April 11, 2024

Record last verified: 2023-05

Locations