Ankle InjuryNCT06653491
Immediate Effects of the HVLA Talocrural Distraction Technique in Soccer Players
A study testing high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure and simulated ankle technique in people with Ankle Injury and Plantar Pressure, run by Universidad Complutense de Madrid.
Trial summary
This clinical trial aims to evaluate the effect of a high-speed, low-amplitude physiotherapy technique at the ankle level, when performed on amateur soccer players. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Injury, Plantar Pressure
- What is being tested?
- high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure and simulated ankle technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Feb 2025
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men over 18 years old
- Men that played or have played soccer as an amateur or professional on a regular basis
- No previous musculoskeletal history that would contraindicate HLVA techniques (recent fractures, osteosynthesis material placed in the joint, infections...)
Who cannot join
- Subjects under 18 years old
- Subjects who have suffered musculoskeletal pathology in the lower limb that contraindicates manipulation or who have a medical diagnosis of chronic ankle instability
- Subjects who suffer neurological or cognitive alterations that prevent the understanding of questionnaires or physical tests; and those who have not signed the informed consent documents
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immediate Effects of the HVLA Talocrural Distraction Technique in Dorsiflexion, the Plantar Center of Pressure and the Percentage of Rearfoot Loading in Soccer Players
This clinical trial aims to evaluate the effect of a high-speed, low-amplitude physiotherapy technique at the ankle level, when performed on amateur soccer players.
Read the detailed description
In this randomized, single-blind, cross-sectional and prospective clinical trial, the effect on ankle mobility and changes in plantar pressure centers obtained after performing a high-velocity, low-amplitude physiotherapy technique in amateur soccers will be assessed.
Two intervention groups are used; in one of them this treatment will be applied in a real way, and in the other one a simulation will be carried out.
- Conditions
- Ankle Injury, Plantar Pressure
- Being tested
- high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure, simulated ankle technique
- Keywords
- ankle, manual therapy, plantar pressure center, mobility
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressureOther
high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure in a supine position
simulated ankle techniqueOther
simulated ankle technique in a supine position
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure Receives: Other: high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure |
| Active Comparator | Active comparator | simulated ankle technique and changes at the level of mobility and plantar pressure Receives: Other: simulated ankle technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle range of motion
ankle dorsiflexion mobility with a manual dorsiflexion mobility test
Measured: one day
plantar pressure centers
plantar pressure centers using stabilometric platform
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion11 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuryStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidro Fernández López, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653491
- Sponsor's protocol ID
- UComplutenseMadrid HVLA ankle
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamali F, Sinaei E, Bahadorian S. The immediate effect of talocrural joint manipulation on functional performance of 15-40 years old athletes with chronic ankle instability: A double-blind randomized clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):830-834. doi: 10.1016/j.jbmt.2017.01.010. Epub 2017 Jan 25.
PubMed 29037635Manoel LS, Xixirry MG, Soeira TP, Saad MC, Riberto M. Identification of Ankle Injury Risk Factors in Professional Soccer Players Through a Preseason Functional Assessment. Orthop J Sports Med. 2020 Jun 24;8(6):2325967120928434. doi: 10.1177/2325967120928434. eCollection 2020 Jun.
PubMed 32637431Knuckles AM, Torp DM, Hubbard-Turner T, Donovan L, Thomas AC. Multi-axis destabilisation device influences plantar pressure distribution in adults with chronic ankle instability. Sports Biomech. 2022 Apr;21(4):501-516. doi: 10.1080/14763141.2021.1896773. Epub 2021 Mar 28.
PubMed 33779500
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of the HVLA Talocrural Distraction Technique in Dorsiflexion, the Plantar Center of Pressure and the Percentage of Rearfoot Loading in Soccer Players
- ClinicalTrials.gov ID
- NCT06653491
- Acronym / sponsor ID
- UComplutenseMadrid HVLA ankle
- Conditions
- Ankle Injury, Plantar Pressure
- Keywords
- ankle, manual therapy, plantar pressure center, mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 11 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
This clinical trial aims to evaluate the effect of a high-speed, low-amplitude physiotherapy technique at the ankle level, when performed on amateur soccer players.
Detailed description
In this randomized, single-blind, cross-sectional and prospective clinical trial, the effect on ankle mobility and changes in plantar pressure centers obtained after performing a high-velocity, low-amplitude physiotherapy technique in amateur soccers will be assessed.
Two intervention groups are used; in one of them this treatment will be applied in a real way, and in the other one a simulation will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressurehigh-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure |
| Active Comparator | Active comparator | Other: simulated ankle techniquesimulated ankle technique and changes at the level of mobility and plantar pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men over 18 years old
- Men that played or have played soccer as an amateur or professional on a regular basis
- No previous musculoskeletal history that would contraindicate HLVA techniques (recent fractures, osteosynthesis material placed in the joint, infections...)
Key exclusion criteria (3 listed)
- Subjects under 18 years old
- Subjects who have suffered musculoskeletal pathology in the lower limb that contraindicates manipulation or who have a medical diagnosis of chronic ankle instability
- Subjects who suffer neurological or cognitive alterations that prevent the understanding of questionnaires or physical tests; and those who have not signed the informed consent documents
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 |
|---|---|---|
| high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressurehigh-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure in a supine position | Other | Experimental |
| simulated ankle techniquesimulated ankle technique in a supine position | Other | Active Comparator |
Primary outcome
Ankle range of motion
Time frame: one day
ankle dorsiflexion mobility with a manual dorsiflexion mobility test
plantar pressure centers
Time frame: one day
plantar pressure centers using stabilometric platform
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Results publication: PubMed 29037635Kamali F, Sinaei E, Bahadorian S. The immediate effect of talocrural joint manipulation on functional performance of 15-40 years old athletes with chronic ankle instability: A double-blind randomized clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):830-834. doi: 10.1016/j.jbmt.2017.01.010. Epub 2017 Jan 25.
- Results publication: PubMed 32637431Manoel LS, Xixirry MG, Soeira TP, Saad MC, Riberto M. Identification of Ankle Injury Risk Factors in Professional Soccer Players Through a Preseason Functional Assessment. Orthop J Sports Med. 2020 Jun 24;8(6):2325967120928434. doi: 10.1177/2325967120928434. eCollection 2020 Jun.
- Results publication: PubMed 33779500Knuckles AM, Torp DM, Hubbard-Turner T, Donovan L, Thomas AC. Multi-axis destabilisation device influences plantar pressure distribution in adults with chronic ankle instability. Sports Biomech. 2022 Apr;21(4):501-516. doi: 10.1080/14763141.2021.1896773. Epub 2021 Mar 28.
- Individual participant dataSharing planned: No
Related trials for Ankle Injury
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
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.
Questions about this trial
What is this clinical trial studying?
A study testing high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure and simulated ankle technique in people with Ankle Injury and Plantar Pressure, run by Universidad Complutense de Madrid.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isidro Fernández-López, PT PhD (+34 625598970, isidrofe@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle range of motion (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653491, which also lists 3 linked publications.
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 22 Oct 2024.