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Evaluation of Proprioception (PROPRIO_TPG)

Primary Purpose

Proprioceptive Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Reconditioning Proprioception
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Proprioceptive Disorders focused on measuring total knee arthroplasty, Proprioception, osteoarthritis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Reconditioning Proprioception group

Control group

Arm Description

Training Proprioception 1 hour for 2 day a week

Outcomes

Primary Outcome Measures

Improvement of a proprioception
Stability Index (SI) in percentage the maximum is 100%

Secondary Outcome Measures

Evaluation of performance in lower limb questionnaire
Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)
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
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.

Full Information

First Posted
February 7, 2019
Last Updated
May 16, 2023
Sponsor
Istituto Ortopedico Rizzoli
Collaborators
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03837041
Brief Title
Evaluation of Proprioception
Acronym
PROPRIO_TPG
Official Title
Evaluate the Proprioception in Patients With Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli
Collaborators
University of Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proprioceptive Disorders
Keywords
total knee arthroplasty, Proprioception, osteoarthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reconditioning Proprioception group
Arm Type
Active Comparator
Arm Description
Training Proprioception 1 hour for 2 day a week
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Reconditioning Proprioception
Intervention Description
Proprioceptive training using Delos Postural Proprioceptive System
Primary Outcome Measure Information:
Title
Improvement of a proprioception
Description
Stability Index (SI) in percentage the maximum is 100%
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Evaluation of performance in lower limb questionnaire
Description
Short Physical Performance Battery - SPPB The score range from 0 (wost performance) to 12 (best performance)
Time Frame
24 months
Title
KSS Score
Description
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
Time Frame
24 months
Title
Clinical score
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of Proprioception

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