NCT06771089

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

December 30, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

Ankle dorsiflexionFootballTherapeutic exerciseMobilization with movementKnee dynamic valgus

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • Dynamic knee valgus with the Single Leg Squat (SLS) test.

    4 weeks

Study Arms (3)

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.

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.

Other: Therapeutic exercise

Control group (CG)

PLACEBO COMPARATOR

The CG group received no specific treatment; they only participated in the current training sessions.

Other: No specific treatment

Interventions

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.

Manual therapy group (MTG)

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.

Therapeutic exercise group (EG)

The Control group received no specific treatment; they only participated in the current training sessions.

Control group (CG)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vigo

Pontevedra, Pontevedra, 36005, Spain

Location

MeSH Terms

Interventions

Musculoskeletal ManipulationsExercise Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Design

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

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 13, 2025

Study Start

December 1, 2023

Primary Completion

February 2, 2024

Study Completion

March 2, 2024

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations