Young PeopleNCT05859256
Flossing Protocol and Manual Therapy in Young Subjects With Recurrent Ankle Sprains
A study testing Experimental in people with Young People, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Young People
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2023to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Young People
- Being tested
- Experimental, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start6 May 2023
- Primary completion3 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
- Investigators
- Rubén Cuesta-Barriuso, PhD, Study director, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859256
- Sponsor's protocol ID
- Flossing
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05859256
- Acronym / sponsor ID
- Flossing
- Conditions
- Young People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ExperimentalThe 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. |
| Control group | Placebo comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalThe 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 group |
| ControlThe same procedures will be carried out, but placing the flossing without tension and performing the Kaltenborn manual techniques without sliding and without joint mobilization. | Other | Control group |
Primary outcome
Change from baseline ankle range of motion after treatment and at 4 weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
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).
2 secondary outcomes
Change from baseline pressure pain threshold treatment and at 4 weeks
Time frame: 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
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD study director
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Young People, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline ankle range of motion after treatment and at 4 weeks (time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.