Functional Ankle InstabilityNCT07817342
Effects of an Exercice Program of 4-w for the Improvement of Functional Ankle Instability in Basketball Players
A study testing Therapeutic exercise and Regular training in people with Functional Ankle Instability, run by CEU San Pablo University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years, men only
- Conditions the study is for
- Functional Ankle Instability
- What is being tested?
- Therapeutic exercise and Regular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 3 Nov 2023to 10 Jan 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 16 to 25 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Four Week Exercise Program on the Improvement of Functional Ankle Instability in Young Basketball Players
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?
Read the detailed description
In this study, the research team will test an exercise program directed to a group of young basketball players compared to another group that simply performs their usual training.
Loaded ankle dorsiflexion, the modified star excursion balance test, the Cumberland Ankle Instability Tool, and the foot-lift test were collected as outcome measures.
The measurements were carried out before the intervention, after and four weeks after finishing the intervention.
- Conditions
- Functional Ankle Instability
- Being tested
- Therapeutic exercise, Regular training
- Keywords
- Therapeutic exercise, Functional ankle instability, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
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.
Regular trainingOther
Regular training program of the basketball team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Other | Therapeutic exercices and regular training Receives: Other: Therapeutic exercise; Other: Regular training |
| Control | Active comparator | Regular training alone Receives: Other: Regular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preintervention, inmediately post-intervention and at four weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start3 Nov 2023
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Functional Ankle InstabilityStudies 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Luis Rodriguez, CEU San Pablo University
- Investigators
- Angel L Rodriguez-Fernandez, PT PhD, Study chair, San Pablo CEU University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817342
- Sponsor's protocol ID
- 4_24_EPE4SJBIFT
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26292174Hebert-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.
PubMed 28886865Plisky 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.
PubMed 17193868Konor 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.
PubMed 22666642Simon 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.
PubMed 22995264Gribble 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.
PubMed 24377963
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Four Week Exercise Program on the Improvement of Functional Ankle Instability in Young Basketball Players
- ClinicalTrials.gov ID
- NCT07817342
- Acronym / sponsor ID
- 4_24_EPE4SJBIFT
- Conditions
- Functional Ankle Instability
- Keywords
- Therapeutic exercise, Functional ankle instability, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 14 Sep 2026 (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 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?
Detailed description
In this study, the research team will test an exercise program directed to a group of young basketball players compared to another group that simply performs their usual training.
Loaded ankle dorsiflexion, the modified star excursion balance test, the Cumberland Ankle Instability Tool, and the foot-lift test were collected as outcome measures.
The measurements were carried out before the intervention, after and four weeks after finishing the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Other: Therapeutic exercise, Other: Regular trainingTherapeutic exercices and regular training |
| Control | Active comparator | Other: Regular trainingRegular training alone |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Therapeutic exerciseA 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. | Other | Experimental |
| Regular trainingRegular training program of the basketball team. | Other | Control, Experimental |
Primary outcome
Toe-to-wall distance
Time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.
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.
Postero-medial Star Excursion Balance Test.
Time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.
The assessor measure the postero-medial distance (cm) of the Star Excursion Balance Test with a measuring tape.
Postero-lateral Star Excursion Balance Test
Time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.
The assessor measure the postero-lateral distance (cm) of the Star Excursion Balance Test with a measuring tape.
Anterior Star Excursion Balance Test
Time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.
The assessor measure the anterior distance (cm) of the Star Excursion Balance Test with a measuring tape.
Cumberlan Ankle Instability Tool
Time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.
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.
Heel-rise test
Time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.
The number of times the subject can raise the heel in single-leg support is counted.
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 14 Sep 2026.
- Background: PubMed 26292174Rodriguez-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.
- Background: PubMed 28886865Hebert-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.
- Background: PubMed 17193868Plisky 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.
- Background: PubMed 22666642Konor 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.
- Background: PubMed 22995264Simon 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.
- Background: PubMed 24377963Gribble 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Functional Ankle Instability
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Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
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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.
Angel L Rodriguez-Fernandez, PT PhD study chair
San Pablo CEU University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Regular training in people with Functional Ankle Instability, run by CEU San Pablo University 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 5 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: finished, as of the sponsor's last update on 14 Sep 2026. 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. 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?
Toe-to-wall distance (time frame: Preintervention, inmediately post-intervention and at four weeks post-intervention.). The study lists 6 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 NCT07817342, which also lists 6 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 14 Sep 2026.