Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2019-02-04
2023-11-11
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with chronic post-traumatic lateral ankle instability
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)
Preoperative evaluation
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 evaluation
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)
Interventions
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Preoperative evaluation
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 evaluation
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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);
* patients with ACL injury;
* patients with severe postural instability;
* patients with cognitive impairments;
* patients with concomitant neurological diseases.
18 Years
40 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Massimiliano Mosca
Role: PRINCIPAL_INVESTIGATOR
Rizzoli Orthopaedic Istitute, Bologna
Locations
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Rizzoli Orthopaedic Institute
Bologna, BO, Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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558/2018/Oss/IOR
Identifier Type: -
Identifier Source: org_study_id