Ankle SprainsANKLE-INTNCT04362488
Evaluation of Ankle Propriocement and Stability
A study testing Preoperative evaluation and Postoperative evaluation in people with Ankle Sprains and Instability, Joint, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Sprains, Instability, Joint
- What is being tested?
- Preoperative evaluation and Postoperative evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2019to 11 Nov 2023
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who must undergo surgery;
- patients of both sexes aged between 18-40 years;
- patients who have given their informed written consent to participate in the study;
- patients who have given their consent to reach the Hospital to perform the 4-month check-up
Who cannot join
- patients with BMI> 30 kg / m2;
- patients with rheumatoid arthritis;
- patients with chronic inflammatory joint diseases;
- patients with pre-existing abnormalities of the ambulatory kinematics (amputations, neuro-muscular diseases, polio, hip dysplasias);
- patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3);
- patients with Severe knee arthritis (Kellgren-Lawrence> 3);
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- patients with ACL injury;
- patients with severe postural instability;
- patients with cognitive impairments;
- patients with concomitant neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.
Read the detailed description
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability using differents tests, questionnaires and instrument:
- Delos system (computerized oscillating platform)
- Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
- modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
- Conditions
- Ankle Sprains, Instability, Joint
- Being tested
- Preoperative evaluation, Postoperative evaluation
- Keywords
- sprain, Brostrom, ankle instability
- Medical subject headings
- Ankle Injuries, Joint Instability, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative evaluationProcedure or surgery
Also called Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"
Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument:
- Delos system (computerized oscillating platform)
- Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
- modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
Postoperative evaluationProcedure or surgery
Also called Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"
Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument:
- Delos system (computerized oscillating platform)
- Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
- modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic post-traumatic lateral ankle instability | Experimental | The study population consists in patients affected by chronic post-traumatic lateral ankle instability who must undergo surgical intervention of ankle external ligament reconstruction.
The patients will be analyzed pre and postoperatively using differents tests, questionnaires, instrument and clinical evaluation:
* Delos system (computerized oscillating platform)
* Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
* modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB) Receives: Procedure: Preoperative evaluation; Procedure: Postoperative evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delos (computerized oscillating platform)
The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population.
Measured: End of the study, 18 month from the beginning (04 August 2020)
Foot & Ankle Ability Measure (FAAM) questionnaire.
FAAM: expresses the personal evaluation of the patient on his difficulty in performing activities using 5 values for each question: no difficulty, slight difficulty, moderate difficulty, extreme difficulty, inability.
Measured: End of the study, 18 month from the beginning (04 August 2020)
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Measured: End of the study, 18 month from the beginning (04 August 2020)
Short Form Health Survey - 12 questionnaire
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
Measured: End of the study, 18 month from the beginning (04 August 2020)
modified Star Excursional Balance Test (mSEBT) functional test
mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground
Measured: End of the study, 18 month from the beginning (04 August 2020)
Short Physical Performance Battery functional test
The SPPB scale is a short battery of tests designed to evaluate the functionality of the lower limbs. This battery consists of 3 different sections. The total score of the scale has a range from 0 to 12.
Measured: End of the study, 18 month from the beginning (04 August 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start4 Feb 2019
- Primary completion1 Feb 2022
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients who undergo surgery for a ankle lateral ligament reconstruction from 4th Febbruary 2019 till to the end of the study on 4th August 2020
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimiliano Mosca, Principal investigator, Rizzoli Orthopaedic Istitute, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362488
- Sponsor's protocol ID
- 558/2018/Oss/IOR
- Acronym
- ANKLE-INT
- Status last verified
- Dec 2023
- First submitted
- 8 Feb 2019
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction
- ClinicalTrials.gov ID
- NCT04362488
- Acronym / sponsor ID
- ANKLE-INT / 558/2018/Oss/IOR
- Conditions
- Ankle Sprains, Instability, Joint
- Keywords
- sprain, Brostrom, ankle instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 27 Apr 2020 (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.
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.
Detailed description
The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability using differents tests, questionnaires and instrument:
- Delos system (computerized oscillating platform)
- Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
- modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients who undergo surgery for a ankle lateral ligament reconstruction from 4th Febbruary 2019 till to the end of the study on 4th August 2020
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic post-traumatic lateral ankle instability | Experimental | Procedure: Preoperative evaluation, Procedure: Postoperative evaluationThe study population consists in patients affected by chronic post-traumatic lateral ankle instability who must undergo surgical intervention of ankle external ligament reconstruction. The patients will be analyzed pre and postoperatively using differents tests, questionnaires, instrument and clinical evaluation: * Delos system (computerized oscillating platform) * Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires * modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients who must undergo surgery;
- patients of both sexes aged between 18-40 years;
- patients who have given their informed written consent to participate in the study;
- patients who have given their consent to reach the Hospital to perform the 4-month check-up
Key exclusion criteria (10 listed)
- patients with BMI> 30 kg / m2;
- patients with rheumatoid arthritis;
- patients with chronic inflammatory joint diseases;
- patients with pre-existing abnormalities of the ambulatory kinematics (amputations, neuro-muscular diseases, polio, hip dysplasias);
- patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3);
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 |
|---|---|---|
| Preoperative evaluationAlso: Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument: * Delos system (computerized oscillating platform) * Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires * modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB) | Procedure or surgery | Patients with chronic post-traumatic lateral ankle instability |
| Postoperative evaluationAlso: Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument: * Delos system (computerized oscillating platform) * Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires * modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB) | Procedure or surgery | Patients with chronic post-traumatic lateral ankle instability |
Primary outcome
Delos (computerized oscillating platform)
Time frame: End of the study, 18 month from the beginning (04 August 2020)
The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population.
Foot & Ankle Ability Measure (FAAM) questionnaire.
Time frame: End of the study, 18 month from the beginning (04 August 2020)
FAAM: expresses the personal evaluation of the patient on his difficulty in performing activities using 5 values for each question: no difficulty, slight difficulty, moderate difficulty, extreme difficulty, inability.
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Time frame: End of the study, 18 month from the beginning (04 August 2020)
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Short Form Health Survey - 12 questionnaire
Time frame: End of the study, 18 month from the beginning (04 August 2020)
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
modified Star Excursional Balance Test (mSEBT) functional test
Time frame: End of the study, 18 month from the beginning (04 August 2020)
mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground
Short Physical Performance Battery functional test
Time frame: End of the study, 18 month from the beginning (04 August 2020)
The SPPB scale is a short battery of tests designed to evaluate the functionality of the lower limbs. This battery consists of 3 different sections. The total score of the scale has a range from 0 to 12.
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 6 Dec 2023.
- 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.
Massimiliano Mosca principal investigator
Rizzoli Orthopaedic Istitute, Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative evaluation and Postoperative evaluation in people with Ankle Sprains and Instability, Joint, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 4 inclusion and 10 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 6 Dec 2023. 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 Italy. 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?
Delos (computerized oscillating platform) (time frame: End of the study, 18 month from the beginning (04 August 2020)). 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?
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 6 Dec 2023.