Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Proprioception (PROPRIO_TPG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837041
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
University of Bologna
Information provided by (Responsible Party):
Stefano Zaffagnini, Istituto Ortopedico Rizzoli

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Proprioceptive Disorders Other: Reconditioning Proprioception Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluate the Proprioception in Patients With Total Knee Arthroplasty
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Balance Problems

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improvement of a proprioception [ Time Frame: 24 months ]
    Stability Index (SI) in percentage the maximum is 100%


Secondary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837041


Contacts
Layout table for location contacts
Contact: Laura Bragonzoni, PhD +390516366516 laura.bragonzoni4@unibo.it
Contact: Stefano Zaffagnini, Full professor +300516366075 stefano.zaffagnini@unibo.it

Locations
Layout table for location information
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Laura Bragonzoni, Phd    +0390516366516    laura.bragonzoni4@unibo.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
University of Bologna
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Stefano Zaffagnini, Full Professor and Head of department, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03837041    
Other Study ID Numbers: 12/17
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefano Zaffagnini, Istituto Ortopedico Rizzoli:
total knee arthroplasty
Proprioception
osteoarthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases