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Completed

NCT Number: NCT03837041

Evaluation of Proprioception

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.

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Key information

Conditions

Proprioceptive Disorders Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconditioning Proprioception

Other

Proprioceptive training using Delos Postural Proprioceptive System

Primary outcomes

  1. Improvement of a proprioception

    Time frame: 24 months

    Stability Index (SI) in percentage the maximum is 100%

Secondary outcomes

  1. Evaluation of performance in lower limb questionnaire

    Time frame: 24 months

    Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)

  2. KSS Score

    Time frame: 24 months

    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

  3. Clinical score

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • University of Bologna

Registry information

Official study title

Evaluate the Proprioception in Patients with Total Knee Arthroplasty

Acronym: PROPRIO_TPG

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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