Evaluation of Proprioception (PROPRIO_TPG)

May 16, 2023 updated by: Stefano Zaffagnini, Istituto Ortopedico Rizzoli

Evaluate the Proprioception in Patients With Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of a proprioception
Time Frame: 24 months
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
Time Frame: 24 months
Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)
24 months
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
24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Collaborators

University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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