Ankle Inversion SprainNCT04210518
Balance Training With Stroboscopic Vision
A study testing Neuromuscular training and Stroboscopic glasses in people with Ankle Inversion Sprain and Proprioceptive Disorders, run by University of Jaén at 1 site in Spain.
Trial summary
Balance training with stroboscopic vision in patients with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Inversion Sprain, Proprioceptive Disorders
- What is being tested?
- Neuromuscular training and Stroboscopic glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2019to 20 Jul 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a previous episode of ankle sprain in at least 6 months before the beginning of the study
- a score of 25 or less in the Cumberland Ankle Instability Tool
- no history of others musculoskeletal injuries in the lower limbs
Who cannot join
- an acute ankle sprain within the last six weeks
- Recent lower limb surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Stroboscopic Vision on Balance in Patients With Chronic Ankle Instability
Balance training with stroboscopic vision in patients with chronic ankle instability.
Read the detailed description
This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.
- Conditions
- Ankle Inversion Sprain, Proprioceptive Disorders
- Being tested
- Neuromuscular training, Stroboscopic glasses
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular trainingOther
This intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle. The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist
Stroboscopic glassesOther
Patients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular training | Experimental | Neuromuscular training consisting of:
* Single limb balance task.
* Balance training on an unstable surface.
* Hop drills. Receives: Other: Neuromuscular training |
| Stroboscopic glasses group | Experimental | This group performed the same neuromuscular training with the addition of stroboscopic glasses during the training performance.
* Single limb balance task.
* Balance training on unstable surfaces.
* Hop drills. Receives: Other: Stroboscopic glasses |
| Control group | No intervention | This group received no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 six 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 six weeks.
Secondary outcomes (1)
Self-reported instability and function
To determine the severity of ankle instability the Cumberland ankle instability tool. This questionnaire is a nine items questionnaire ranged from 0 to 30 (0 related with severe impairment and 30 no subjective instability feeling) and has been reported to be a valid tool with high internal consistency and reliability.
Measured: From baseline to six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start2 May 2019
- Primary completion10 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Inversion SprainStudies 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
- This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210518
- Sponsor's protocol ID
- UJASB
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Stroboscopic Vision on Balance in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT04210518
- Acronym / sponsor ID
- UJASB
- Conditions
- Ankle Inversion Sprain, Proprioceptive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- 2 May 2019 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 24 Dec 2019 (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.
Balance training with stroboscopic vision in patients with chronic ankle instability.
Detailed description
This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group who received no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group.
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular training | Experimental | Other: Neuromuscular trainingNeuromuscular training consisting of: * Single limb balance task. * Balance training on an unstable surface. * Hop drills. |
| Stroboscopic glasses group | Experimental | Other: Stroboscopic glassesThis group performed the same neuromuscular training with the addition of stroboscopic glasses during the training performance. * Single limb balance task. * Balance training on unstable surfaces. * Hop drills. |
| Control group | No intervention | –This group received no intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a previous episode of ankle sprain in at least 6 months before the beginning of the study
- a score of 25 or less in the Cumberland Ankle Instability Tool
- no history of others musculoskeletal injuries in the lower limbs
Key exclusion criteria (2 listed)
- an acute ankle sprain within the last six weeks
- Recent lower limb surgery
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 |
|---|---|---|
| Neuromuscular trainingThis intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle. The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist | Other | Neuromuscular training |
| Stroboscopic glassesPatients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention. | Other | Stroboscopic glasses group |
Primary outcome
Ankle range of motion
Time frame: From baseline to six weeks.
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.
Dynamic balance
Time frame: From baseline to six weeks.
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.
1 secondary outcome
Self-reported instability and function
Time frame: From baseline to six 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 24 Dec 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training and Stroboscopic glasses in people with Ankle Inversion Sprain and Proprioceptive Disorders, run by University of Jaén 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 3 inclusion and 2 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 24 Dec 2019. 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?
Ankle range of motion (time frame: From baseline to six weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2019.