Ankle DorsiflexionNCT06771089
Effectiveness of a Therapeutic Exercise Protocol Vs a Mobilisation with Movement Protocol in Improving Ankle Dorsiflexion in Amateur Football Players
A study testing Manual therapy and bandaging, Therapeutic exercise and No specific treatment in people with Ankle Dorsiflexion, run by University of Vigo at 1 site in Spain.
Trial summary
Objective: To evaluate and compare the immediate and short-term effectiveness of a therapeutic exercise protocol and a mobilisation with movement protocol, compared with a control group, in improving ankle dorsiflexion in amateur footballers. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ankle Dorsiflexion
- What is being tested?
- Manual therapy and bandaging, Therapeutic exercise and No specific treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 2 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Football players over 18 years old who train a minimum of 3 days a week.
- Football players with ankle DF less than 9 cm or a difference greater than 1.5 cm between both feet, measured with the Ankle Lunge Test (ALT) using the LegMOtion© device.
Who cannot join
- Players who, during the ALT, achieve less than 9 cm or a difference greater than 1.5 cm between both feet but reporting limitation due to tension in the gastrocnemius muscle.
- Those with serious traumatic or rheumatological conditions that may interfere with the study.
- Players who have participated in specific programs to improve ankle DF in the last 3 months.
- Players with a history of ankle-foot surgery within the last 6 months.
- Non-registered players training in those clubs.
- Players unable to arrive 20 minutes prior to the beginning of the training session.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of the Effectiveness of a Therapeutic Exercise Protocol Vs a Mobilisation with Movement Protocol in Improving Ankle Dorsiflexion in Amateur Football Players. Randomised Controlled Pilot Study
Objective: To evaluate and compare the immediate and short-term effectiveness of a therapeutic exercise protocol and a mobilisation with movement protocol, compared with a control group, in improving ankle dorsiflexion in amateur footballers.
Material and methods: A single-blind randomised controlled pilot study was developed. Participants were amateur football players randomized into 3 groups (therapeutic exercise, mobilization with movement and control). The intervention was carried out with 2 weekly sessions for 4 weeks. Assessment tools included the Ankle Lunge Test and the Single Leg Squat.
- Conditions
- Ankle Dorsiflexion
- Being tested
- Manual therapy and bandaging, Therapeutic exercise, No specific treatment
- Keywords
- Ankle dorsiflexion, Football, Therapeutic exercise, Mobilization with movement, Knee dynamic valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and bandagingOther
The MTG group received an intervention based on anterior-posterior mobilizations of the talus and fibula and taping, both based on Mulligan® techniques Individually, participants received Grade IV passive mobilizations lasting approximately 30 seconds, totalling 12 active mobilizations performed by the participant. Furthermore, a tape was applied, placed on the anterior part of the talus with a posterior and caudal direction, with its ends anchored near the heel. Due to its placement, this taping maintained a sustained posterior force on the talus throughout the training session. This intervention was conducted on the affected limb(s) with DF deficits.
Therapeutic exerciseOther
Therapeutic exercise protocol lasting approximately 5-10 minutes, performed before regular training sessions. It included 2 exercises, each performed in 3 sets of 10 repetitions with 1-minute rest intervals.
Exercise 1: Weighted DF in a kneeling position. From this position, ankle DF is performed with the front leg, on which the weight of the arms and the torso is placed to force the movement.
Exercise 2: Ankle lunge with band resistance at the ankle. The player performs ankle DF with a medium-resistance green Theraband® providing a posterior force vector on the talus.
This intervention was applied to the affected limb(s) with ankle DF limitations and was supervised by a physiotherapist. It was performed before training session at each club's facilities.
No specific treatmentOther
The Control group received no specific treatment; they only participated in the current training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy group (MTG) | Experimental | The MTG group received an intervention based on anterior-posterior mobilizations of the talus and fibula and taping, both based on Mulligan® techniques. Receives: Other: Manual therapy and bandaging |
| Therapeutic exercise group (EG) | Experimental | The EG group underwent a therapeutic exercise protocol lasting approximately 5-10 minutes, performed before regular training sessions. Receives: Other: Therapeutic exercise |
| Control group (CG) | Placebo comparator | The CG group received no specific treatment; they only participated in the current training sessions. Receives: Other: No specific treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle dorsiflexion with Ankle Lunge Test (ALT) using the LegMOtion© device.
ALT: ankle DF was measured in cm. The player stands with the foot to be assessed placed behind a black line on the device, while the other foot remains on the floor behind the tested foot. The player attempts to touch a metal rod with the knee without lifting the heel off the floor. The rod's position is adjusted to the maximum distance reached with difficulty. 3 repetitions were carried out and an average of the 3 repetitions was calculated to obtain the maximum ankle DF measurement. Both feet were measured.
Measured: 4 weeks
Secondary outcomes (1)
Dynamic knee valgus with the Single Leg Squat (SLS) test.
SLS: The participant, barefoot on a firm, flat surface, first performed 2 practice SLS repetitions unmeasured., then 2 consecutive sets of 5 repetitions were evaluated and the worst set was chosen for analysis., allowing for speed and compensation adjustments as fatigue developed. Each limb was tested. The examiner, positioned directly in front of the participant, recorded the activity with a mobile device. Movement execution was analysed using the Kinovea© software, with analysis focused on measuring the Q angle for each repetition, selecting the largest angle from the 5 executions for analysis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Dec 2023
- Primary completion2 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DorsiflexionStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Iris Machado de Oliveira, Aldara Vázquez Méndez, Adrian Eiró Fernández
- Responsible party
- Principal investigator, Irimia Mollinedo Cardalda, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771089
- Sponsor's protocol ID
- 205-2024-1
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 13 Jan 2025
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effectiveness of a Therapeutic Exercise Protocol Vs a Mobilisation with Movement Protocol in Improving Ankle Dorsiflexion in Amateur Football Players. Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06771089
- Acronym / sponsor ID
- 205-2024-1
- Conditions
- Ankle Dorsiflexion
- Keywords
- Ankle dorsiflexion, Football, Therapeutic exercise, Mobilization with movement, Knee dynamic valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Iris Machado de Oliveira, Aldara Vázquez Méndez, Adrian Eiró Fernández
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 13 Jan 2025 (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.
Objective: To evaluate and compare the immediate and short-term effectiveness of a therapeutic exercise protocol and a mobilisation with movement protocol, compared with a control group, in improving ankle dorsiflexion in amateur footballers.
Material and methods: A single-blind randomised controlled pilot study was developed. Participants were amateur football players randomized into 3 groups (therapeutic exercise, mobilization with movement and control). The intervention was carried out with 2 weekly sessions for 4 weeks. Assessment tools included the Ankle Lunge Test and the Single Leg Squat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual therapy group (MTG) | Experimental | Other: Manual therapy and bandagingThe MTG group received an intervention based on anterior-posterior mobilizations of the talus and fibula and taping, both based on Mulligan® techniques. |
| Therapeutic exercise group (EG) | Experimental | Other: Therapeutic exerciseThe EG group underwent a therapeutic exercise protocol lasting approximately 5-10 minutes, performed before regular training sessions. |
| Control group (CG) | Placebo comparator | Other: No specific treatmentThe CG group received no specific treatment; they only participated in the current training sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Football players over 18 years old who train a minimum of 3 days a week.
- Football players with ankle DF less than 9 cm or a difference greater than 1.5 cm between both feet, measured with the Ankle Lunge Test (ALT) using the LegMOtion© device.
Key exclusion criteria (6 listed)
- Players who, during the ALT, achieve less than 9 cm or a difference greater than 1.5 cm between both feet but reporting limitation due to tension in the gastrocnemius muscle.
- Those with serious traumatic or rheumatological conditions that may interfere with the study.
- Players who have participated in specific programs to improve ankle DF in the last 3 months.
- Players with a history of ankle-foot surgery within the last 6 months.
- Non-registered players training in those clubs.
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 |
|---|---|---|
| Manual therapy and bandagingThe MTG group received an intervention based on anterior-posterior mobilizations of the talus and fibula and taping, both based on Mulligan® techniques Individually, participants received Grade IV passive mobilizations lasting approximately 30 seconds, totalling 12 active mobilizations performed by the participant. Furthermore, a tape was applied, placed on the anterior part of the talus with a posterior and caudal direction, with its ends anchored near the heel. Due to its placement, this taping maintained a sustained posterior force on the talus throughout the training session. This intervention was conducted on the affected limb(s) with DF deficits. | Other | Manual therapy group (MTG) |
| Therapeutic exerciseTherapeutic exercise protocol lasting approximately 5-10 minutes, performed before regular training sessions. It included 2 exercises, each performed in 3 sets of 10 repetitions with 1-minute rest intervals. Exercise 1: Weighted DF in a kneeling position. From this position, ankle DF is performed with the front leg, on which the weight of the arms and the torso is placed to force the movement. Exercise 2: Ankle lunge with band resistance at the ankle. The player performs ankle DF with a medium-resistance green Theraband® providing a posterior force vector on the talus. This intervention was applied to the affected limb(s) with ankle DF limitations and was supervised by a physiotherapist. It was performed before training session at each club's facilities. | Other | Therapeutic exercise group (EG) |
| No specific treatmentThe Control group received no specific treatment; they only participated in the current training sessions. | Other | Control group (CG) |
Primary outcome
Ankle dorsiflexion with Ankle Lunge Test (ALT) using the LegMOtion© device.
Time frame: 4 weeks
ALT: ankle DF was measured in cm. The player stands with the foot to be assessed placed behind a black line on the device, while the other foot remains on the floor behind the tested foot. The player attempts to touch a metal rod with the knee without lifting the heel off the floor. The rod's position is adjusted to the maximum distance reached with difficulty. 3 repetitions were carried out and an average of the 3 repetitions was calculated to obtain the maximum ankle DF measurement. Both feet were measured.
1 secondary outcome
Dynamic knee valgus with the Single Leg Squat (SLS) test.
Time frame: 4 weeks
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 13 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and bandaging, Therapeutic exercise and No specific treatment in people with Ankle Dorsiflexion, run by University of Vigo 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 2 inclusion and 6 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 13 Jan 2025. 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?
Ankle dorsiflexion with Ankle Lunge Test (ALT) using the LegMOtion© device. (time frame: 4 weeks). 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 13 Jan 2025.