Ankle InjuriesNCT05250739
Neuromuscular Training vs Strength Training
A study testing Strength training and Neuromuscular training in people with Ankle Injuries, run by DAVID CRUZ DÍAZ at 1 site in Spain.
Trial summary
Chronic ankle instability is a complex condition. Limited mobility, perceived instability, and recurrent ankle sprains are common characteristics that reduce the quality of life in subjects who suffer chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Strength training and Neuromuscular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 10 Nov 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants could not have suffered an acute sprain in the 6 previous weeks to the beginning of the study.
- History of recent ankle surgery.
- Epilepsy or previous seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromuscular Training vs Strength Training in Chronic Ankle Instability
Chronic ankle instability is a complex condition. Limited mobility, perceived instability, and recurrent ankle sprains are common characteristics that reduce the quality of life in subjects who suffer chronic ankle instability. Neuromuscular training and strength training has been recommended in chronic ankle instability management interventions. However, there are contradictory findings on results when comparing neuromuscular training, strength training, and control group.
Read the detailed description
Participants were randomly assigned to the neuromuscular training group, strength training group, and control group with no intervention if participants met the inclusion criteria.
Neuromuscular training group. It consisted of a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle.
A strength training group was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. Participants were told to control the ankle movement and to make it slow.
Control group received no intervention.
- Conditions
- Ankle Injuries
- Being tested
- Strength training, Neuromuscular training
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Strength training was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. They were told to control the ankle movement and to make it slow. Since the first day, they were told to perform the exercise pulling the band as if they wanted to make the resistance of 5 on a scale from 0 to 10.
Neuromuscular trainingOther
consisted in a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle. The participants did not start the next progression until they perform a complete circuit in the level before.
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Participants completed 16 training sessions of strength training during eight weeks. Receives: Other: Strength training |
| Neuromuscular training | Experimental | Participants completed 16 training sessions of neuromuscular training during eight weeks. Receives: Other: Neuromuscular training |
| Control group | No intervention | The Control group received no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported instability
To determine the presence and severity of chronic ankle instability, participants completed the Cumberland Ankle Instability Tool, a valid and reliable instrument for measuring the severity of ankle instability. The Cumberland Ankle Instability Tool is a 9-item subjective questionnaire with a range score from 0 (severe instability) to 30 (normal stability)
Measured: From baseline to eight weeks
Secondary outcomes (3)
Ankle range of motion
Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.
Measured: From baseline to eight weeks
Dynamic balance
Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.
Measured: From baseline to eight weeks
Functional status
Function in daily living and sport activities were assessed by the Foot and Ankle Ability Measure. This questionnaire Is divided by two subscales of 21 items (daily living subscale) and 8 items (sports subscale). The obtained score is expressed as a percentage calculated by dividing the patient's score by max score and the lower percentage is related to the lower level of function.
Measured: From baseline to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies 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
- A single-blind randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- DAVID CRUZ DÍAZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DAVID CRUZ DÍAZ, University of Jaén
- Investigators
- David Cruz-Diaz, PhD, Principal investigator, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250739
- Sponsor's protocol ID
- ANKLEST
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed due to personal data legal protection issues.
Publications
Halabchi F, Hassabi M. Acute ankle sprain in athletes: Clinical aspects and algorithmic approach. World J Orthop. 2020 Dec 18;11(12):534-558. doi: 10.5312/wjo.v11.i12.534. eCollection 2020 Dec 18.
PubMed 33362991Beynnon BD, Vacek PM, Murphy D, Alosa D, Paller D. First-time inversion ankle ligament trauma: the effects of sex, level of competition, and sport on the incidence of injury. Am J Sports Med. 2005 Oct;33(10):1485-91. doi: 10.1177/0363546505275490. Epub 2005 Jul 11.
PubMed 16009979Ahern L, Nicholson O, O'Sullivan D, McVeigh JG. Effect of Functional Rehabilitation on Performance of the Star Excursion Balance Test Among Recreational Athletes With Chronic Ankle Instability: A Systematic Review. Arch Rehabil Res Clin Transl. 2021 May 21;3(3):100133. doi: 10.1016/j.arrct.2021.100133. eCollection 2021 Sep.
PubMed 34589684
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Training vs Strength Training in Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05250739
- Acronym / sponsor ID
- ANKLEST
- Conditions
- Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- DAVID CRUZ DÍAZUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 22 Feb 2022 (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.
Chronic ankle instability is a complex condition. Limited mobility, perceived instability, and recurrent ankle sprains are common characteristics that reduce the quality of life in subjects who suffer chronic ankle instability. Neuromuscular training and strength training has been recommended in chronic ankle instability management interventions. However, there are contradictory findings on results when comparing neuromuscular training, strength training, and control group.
Detailed description
Participants were randomly assigned to the neuromuscular training group, strength training group, and control group with no intervention if participants met the inclusion criteria.
Neuromuscular training group. It consisted of a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle.
A strength training group was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. Participants were told to control the ankle movement and to make it slow.
Control group received no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A single-blind randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Other: Strength trainingParticipants completed 16 training sessions of strength training during eight weeks. |
| Neuromuscular training | Experimental | Other: Neuromuscular trainingParticipants completed 16 training sessions of neuromuscular training during eight weeks. |
| Control group | No intervention | –The Control group received no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Participants could not have suffered an acute sprain in the 6 previous weeks to the beginning of the study.
- History of recent ankle surgery.
- Epilepsy or previous seizures.
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 |
|---|---|---|
| Strength trainingStrength training was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. They were told to control the ankle movement and to make it slow. Since the first day, they were told to perform the exercise pulling the band as if they wanted to make the resistance of 5 on a scale from 0 to 10. | Other | Strength training |
| Neuromuscular trainingconsisted in a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle. The participants did not start the next progression until they perform a complete circuit in the level before. | Other | Neuromuscular training |
Primary outcome
Self-reported instability
Time frame: From baseline to eight weeks
To determine the presence and severity of chronic ankle instability, participants completed the Cumberland Ankle Instability Tool, a valid and reliable instrument for measuring the severity of ankle instability. The Cumberland Ankle Instability Tool is a 9-item subjective questionnaire with a range score from 0 (severe instability) to 30 (normal stability)
3 secondary outcomes
Ankle range of motion
Time frame: From baseline to eight weeks
Dynamic balance
Time frame: From baseline to eight weeks
Functional status
Time frame: From baseline to eight 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 10 Mar 2022.
- Background: PubMed 33362991Halabchi F, Hassabi M. Acute ankle sprain in athletes: Clinical aspects and algorithmic approach. World J Orthop. 2020 Dec 18;11(12):534-558. doi: 10.5312/wjo.v11.i12.534. eCollection 2020 Dec 18.
- Background: PubMed 16009979Beynnon BD, Vacek PM, Murphy D, Alosa D, Paller D. First-time inversion ankle ligament trauma: the effects of sex, level of competition, and sport on the incidence of injury. Am J Sports Med. 2005 Oct;33(10):1485-91. doi: 10.1177/0363546505275490. Epub 2005 Jul 11.
- Background: PubMed 34589684Ahern L, Nicholson O, O'Sullivan D, McVeigh JG. Effect of Functional Rehabilitation on Performance of the Star Excursion Balance Test Among Recreational Athletes With Chronic Ankle Instability: A Systematic Review. Arch Rehabil Res Clin Transl. 2021 May 21;3(3):100133. doi: 10.1016/j.arrct.2021.100133. eCollection 2021 Sep.
- Individual participant dataSharing planned: No. Not allowed due to personal data legal protection issues.
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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.
David Cruz-Diaz, PhD principal investigator
University of Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and Neuromuscular training in people with Ankle Injuries, run by DAVID CRUZ DÍAZ 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 0 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 10 Mar 2022. 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?
Self-reported instability (time frame: From baseline to eight weeks). 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 NCT05250739, which also lists 3 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 10 Mar 2022.