Motor Performance Modulation After Total Knee Replacement

September 8, 2021 updated by: Istituto Clinico Humanitas

Functional recovery after total knee replacement (TKR) is characterized by an incomplete muscle strength due to arthrogenic muscle inhibition (AMI) and tendency to estimate the functional level. These deficits could be related to alteration of sensory feedback, and could influence the ability to modulate patients' motor performance.

To date, there are not studies investigatin the ability to modulate the motor performance in patients with TKR compared to healthy age-matched subjects.

In this study 20 patients with TKR and 20 healthy will be included . Inclusion criteria are: age between 40 and 80 , TKR for primary knee osteoarthritis, knee flexion ≥ 90° and complete knee extension, ability to perform a sit to stand on a 46 cm high chair and to walk for at least 50 meters without aids. Exclusion criteria: patients undergoing TKR after traumas, previous tibial or femoral osteotomy, partial or complete revision surgery. subjects with psychiatric and/or cognitive impairments, or with neurological, musculoskeletal or other disorders that could influence motor or functional recovery will be also exluded.

The aim of the study is to investigate the ability in motor performance modulation in patients after TKR compared to healthy age-mtched subjects.

Primary endpoint is to investigate this ability during a leg extension performed in open kinetic chain. This ability will be also evaluated during a Sit To Stand and during walking (with 10 Meters Walking Test). Secondary endpoint is to investigate pain, rate of perceived exertion and perceived load symmetry during the three tests. In both healthy and TKR groups these outcomes will be detected two times. In particular, in TKR group, patients will be tested the day before surgery and 5 days after surgery.

This study is aimed at conducting a survey in healthy subjects and in a population of subjects undergoing TKR . Participants will undergo an acquisition similar to others already described in the literature and without adverse events. Tests will last about 60 minutes and during them, will be used the equipment of Motion Analysis Lab of "Humanitas Research Hospital".

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

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
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients: subjects undergoing total knee replacement intervention because of primary gonarthrosis.

Healty subjects: people with no known significant health problems who are recruited to participate as controls for a patient Group.

Description

Inclusion Criteria:

  • Age between 40 and 80 years
  • TKR because of primary gonarthrosis
  • Flexion ≥ 90° and complete knee extension
  • Able to perform a Sit to Stand from a 46 cm high chair, without upper limb use
  • Able to walk at least 50 meters without walking aids

Exclusion Criteria:

  • TKR because of traumatic event
  • Patients undergone to tibial or femoral osteotomy
  • Partial or Total TKR revision
  • Cognitive and psychiatric impairments
  • Presence of neurological, internist or musculoskeletal system pathologies that may affect functional or motor recovery

Healthy subjects will have to comply with all the eligibility criteria just mentioned except for the inclusion criterion: Intervention of TKR following primary gonarthrosis

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy subjects
Patients TKR
Procedure: TKR
No intervention provided, but investigation of the ability to modulate motor performance during specific and functional tasks in subjects undergoing TKR compared with healthy subjects.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Peak Torque (PT) in N*m
Time Frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Force reproduction error between the PT-target and the PT-observed during knee extension with an isokinetic dynamometer (Ω = 60 °/s)
Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Overshoot (OS) in N
Time Frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
The error between OS-target and OS-observed during Sit-to-Stand using two force platforms.
Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in Walking speed (WS) in m/s
Time Frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Error between "target speed" and "observed speed" during 10 meters walking test
Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in pain using Visual Analogue Scale (VAS)
Time Frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)
Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in exertion using Modified Borg Scale
Time Frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Perceived exertion will be assessed with Modified Borg Scale (0-10), ranging from 0 (no exertion) to 10 (maximum exertion)
Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in perceived body weight distribution using Visual Analogue Scale (VAS)
Time Frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Perceived symmetry of load will be assessed with Visual Analogue Scale (VAS), ranging from -10 (body weight on left limb) to 10 (body weight on right limb). A value of 0 denotes perfect symmetry.
Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 749

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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