NCT07817342

Brief Summary

Objective: to investigate the effects of a four weeks exercise program for the improvement of the ankle range of movement, balance, strength and subjective symptomps in young basketball player with functional ankle instability. PICO: Is a four weeks exercise program effective to improve ankle range of motion, balance, strenght and subjective symtomps in young basketball players with functional ankle instability?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

November 27, 2024

Last Update Submit

September 11, 2026

Conditions

Keywords

Therapeutic exerciseFunctional ankle instabilityPhysiotherapy

Outcome Measures

Primary Outcomes (6)

  • Toe-to-wall distance

    It is an indirect measure of the ankle dorsiflexion. The assessor record the distance (cm) between the big toe and the while maintaining contact between the knee and wall without lifting the heel with a measuring tape.

    Preintervention, inmediately post-intervention and at four weeks post-intervention.

  • Postero-medial Star Excursion Balance Test.

    The assessor measure the postero-medial distance (cm) of the Star Excursion Balance Test with a measuring tape.

    Preintervention, inmediately post-intervention and at four weeks post-intervention.

  • Postero-lateral Star Excursion Balance Test

    The assessor measure the postero-lateral distance (cm) of the Star Excursion Balance Test with a measuring tape.

    Preintervention, inmediately post-intervention and at four weeks post-intervention.

  • Anterior Star Excursion Balance Test

    The assessor measure the anterior distance (cm) of the Star Excursion Balance Test with a measuring tape.

    Preintervention, inmediately post-intervention and at four weeks post-intervention.

  • Cumberlan Ankle Instability Tool

    Score of the Spanish version of the Cumberland Ankle Instability Tool (CAIT-Sv). It is a self-administer questionnaire to assess the severity of chronic ankle instability. It is scored from 0 to 30 with higher score indicating better ankle functionality.

    Preintervention, inmediately post-intervention and at four weeks post-intervention.

  • Heel-rise test

    The number of times the subject can raise the heel in single-leg support is counted.

    Preintervention, inmediately post-intervention and at four weeks post-intervention.

Study Arms (2)

Experimental

OTHER

Therapeutic exercices and regular training

Other: Therapeutic exerciseOther: Regular training

Control

ACTIVE COMPARATOR

Regular training alone

Other: Regular training

Interventions

A three per week sessions of therapeutic exercise program during four weeks including movility, strength, motor control and plyometric exercises. This program was made simultaneously to the regular training of the basketball team.

Experimental

Regular training program of the basketball team.

ControlExperimental

Eligibility Criteria

Age16 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male basketball players with at least 6 training sesion for week.
  • Aged 16-25 years old.
  • At least one ankle sprain that caused unloading of support of the affected lower limb for more than one day.
  • A history of recurrent akle spraints and/or giving way sensations.
  • A score higest of 11 points in the Spanish version of the IdFAI.

You may not qualify if:

  • History of musculoskeletal surgery in any region of lower limb.
  • History of fractures in the ankle region, having required surgery or not.
  • Acute ankle sprain in the 6 weeks prior to the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Club Zentro Basket Madrid

Madrid, Madrid, 28029, Spain

Location

Related Publications (6)

  • Rodriguez-Fernandez AL, Rebollo-Roldan J, Jimenez-Rejano JJ, Gueita-Rodriguez J. Psychometric properties of the Spanish version of the Cumberland Ankle Instability Tool. Disabil Rehabil. 2015;37(20):1888-94. doi: 10.3109/09638288.2014.984879. Epub 2015 Jul 9.

    PMID: 26292174BACKGROUND
  • Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.

    PMID: 28886865BACKGROUND
  • Plisky PJ, Rauh MJ, Kaminski TW, Underwood FB. Star Excursion Balance Test as a predictor of lower extremity injury in high school basketball players. J Orthop Sports Phys Ther. 2006 Dec;36(12):911-9. doi: 10.2519/jospt.2006.2244.

    PMID: 17193868BACKGROUND
  • Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.

    PMID: 22666642BACKGROUND
  • Simon J, Donahue M, Docherty C. Development of the Identification of Functional Ankle Instability (IdFAI). Foot Ankle Int. 2012 Sep;33(9):755-63. doi: 10.3113/FAI.2012.0755.

    PMID: 22995264BACKGROUND
  • Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.

    PMID: 24377963BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Angel L Rodriguez-Fernandez, PT PhD

    San Pablo CEU University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention 1 (Experimental group): a progressive exercise program directed to improve movility, motor control, strength and plyometry. This program was made 3 times a week for four weeks and added to the regular training program. Intervention 2 (control group): This group only made the regular training program of the basketball team.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2024

First Posted

September 14, 2026

Study Start

November 3, 2023

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The researches only will shared IPD data if requested by the journal. The researches want to respect the sensitive clinical data of the study participants.

Locations