Ankle SprainsANKLE-PRONCT05868681
Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
A study testing Delos instrument (computerized balance board) 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 post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to 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?
- Delos instrument (computerized balance board)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2018to 12 Feb 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients already undergoing surgery and with at least 4 months of follow-up;
- 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 the willingness to reach the Hospital to carry out the checks.
Who cannot join
- patients with BMI> 30 kg / m2;
- patients with rheumatoid arthritis;
- patients with chronic inflammatory joint diseases;
- patients with pre-existing deambulation kinematics abnormalities (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 severe postural instability;
- patients with cognitive impairments;
- patients with concomitant neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.
Read the detailed description
The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment.
Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system.
Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.
- Conditions
- Ankle Sprains, Instability, Joint
- Being tested
- Delos instrument (computerized balance board)
- Keywords
- Ankle instability, Stabilometry
- Medical subject headings
- Ankle Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delos instrument (computerized balance board)Device
Proprioceptive training using Delos instrument (computerized balance board).
Static and dynamic evaluation through Delos with the Riva method; Physiatric visit; Clinical scores (AOFAs); Functional scores (SPPB); SF12 satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method Receives: Device: Delos instrument (computerized balance board) |
| Control group | No intervention | Normal physiotherapy performed according to standard protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static and Dynamic Stability Index
Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.
Measured: 5 weeks from the start of rehabilitation treatment
Secondary outcomes (2)
Personal perception of the patient
Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)
Measured: 5 weeks from the start of rehabilitation treatment
Clinical test
Stability of the ankle operated evaluated by clinical test
Measured: 5 weeks from the start of rehabilitation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start12 Feb 2018
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868681
- Sponsor's protocol ID
- 0012824
- Acronym
- ANKLE-PRO
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2018
- Last updated
- 22 May 2023
- Results posted
- 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 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
- ClinicalTrials.gov ID
- NCT05868681
- Acronym / sponsor ID
- ANKLE-PRO / 0012824
- Conditions
- Ankle Sprains, Instability, Joint
- Keywords
- Ankle instability, Stabilometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 22 May 2023 (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 post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.
Detailed description
The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment.
Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system.
Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Delos instrument (computerized balance board)Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method |
| Control group | No intervention | –Normal physiotherapy performed according to standard protocols. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients already undergoing surgery and with at least 4 months of follow-up;
- 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 the willingness to reach the Hospital to carry out the checks.
Key exclusion criteria (9 listed)
- patients with BMI> 30 kg / m2;
- patients with rheumatoid arthritis;
- patients with chronic inflammatory joint diseases;
- patients with pre-existing deambulation kinematics abnormalities (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 |
|---|---|---|
| Delos instrument (computerized balance board)Proprioceptive training using Delos instrument (computerized balance board). Static and dynamic evaluation through Delos with the Riva method; Physiatric visit; Clinical scores (AOFAs); Functional scores (SPPB); SF12 satisfaction. | Device | Study group |
Primary outcome
Static and Dynamic Stability Index
Time frame: 5 weeks from the start of rehabilitation treatment
Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.
2 secondary outcomes
Personal perception of the patient
Time frame: 5 weeks from the start of rehabilitation treatment
Clinical test
Time frame: 5 weeks from the start of rehabilitation treatment
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 22 May 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.
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 Delos instrument (computerized balance board) 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 9 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 22 May 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?
Static and Dynamic Stability Index (time frame: 5 weeks from the start of rehabilitation treatment). 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 22 May 2023.