Evaluation of Proprioception

Study Overview
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Brief Summary
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The osteoarthritis (OA) is a chronic and degenerative disease which brings articular cartilage degeneration. As a consequence, balance and proprioception could be dangerously reduced after total knee arthroplasty. Several studies demonstrated the correlation between OA, proprioception reduction and increased risk of falling. The aim of this study is to evaluate the proprioception improvement in patients with total knee arthroplasty.

Official Title
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Evaluate the Proprioception in Patients With Total Knee Arthroplasty

Conditions
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Proprioceptive Disorders

Intervention / Treatment
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* Other: Reconditioning Proprioception


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria are patients with ASA: 1, 2 or 3; patients who have given their informed written consent to participate in the study; patients live in Bologna and neighboring areas. Exclusion Criteria are patients with previous osteotomy of the lower limbs; patients with post-traumatic arthrosis; patients with severe preoperative valgus deformity (Hip Knee Ankle angle> 10 °); patients with BMI> 40 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with walking diseases (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3); patients with Severe coxarthrosis (Kellgren-Lawrence> 3); patients with severe postural instability; patients with cognitive impairments, patients with concomitant neurological diseases

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reconditioning Proprioception group<br>Training Proprioception 1 hour for 2 day a week | Other: Reconditioning Proprioception<br>* Proprioceptive training using Delos Postural Proprioceptive System<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of a proprioception | Stability Index (SI) in percentage the maximum is 100% | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of performance in lower limb questionnaire | Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance) | 24 months | 
| KSS Score | The score range from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | 24 months | 
| Clinical score | Western Ontario and McMaster Universities Osteoarthritis Index the WOMAC evaluates 3 dimensions: pain, stiffness, and physical function with 5, 2, and 17 questions, respectively. The Likert version of the WOMAC is rated on an ordinal scale of 0 to 4, with lower scores indicating lower levels of symptoms or physical disability. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, Proprioception, osteoarthritis