NCT06653491

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 20, 2024

Last Update Submit

October 20, 2024

Conditions

Ankle InjuryPlantar Pressure

Keywords

anklemanual therapyplantar pressure centermobility

Outcome Measures

Primary Outcomes (2)

  • Ankle range of motion

    ankle dorsiflexion mobility with a manual dorsiflexion mobility test

    one day

  • plantar pressure centers

    plantar pressure centers using stabilometric platform

    one day

Study Arms (2)

Experimental

EXPERIMENTAL

high-speed, low-amplitude talocrural decompression technique and changes at the level of mobility and plantar pressure

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

Other: simulated ankle technique

Interventions

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

Experimental
simulated ankle techniqueOTHER

simulated ankle technique in a supine position

Active Comparator

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen that played or have played soccer as an amateur or professional on a regular basis
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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...)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29037635RESULT

  • Manoel 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.

    PMID: 32637431RESULT

  • Knuckles 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.

    PMID: 33779500RESULT

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

Isidro Fernández-López, PT PhD

CONTACT

+34 625598970isidrofe@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Department of Radiology, Rehabilitation and Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, Universidad Complutense de Madrid, Madrid, Spain

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 22, 2024

Study Start

December 1, 2024

Primary Completion

January 11, 2025

Study Completion

February 1, 2025

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share