Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.

August 16, 2023 updated by: Istituto Clinico Humanitas

The study aims at evaluating the effects of one session of Action Observation Training (AOT) and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in subjects with end-stage gonarthrosis.

30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two groups (experimental group and control group).

Experimental group performed one 6-minutes AOT and MI session with motor content of concentric and isometric QF contractions, whereas control group underwent a 6-minute sham AOT and MI session. Every patient was evaluated to assess the percentage of AMI on the QF before (T0) and after (T1) the treatment following the gold standard Twitch Interpolated Technique.

Study Overview

Status

Status

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

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.

Detailed Description

The study aims at evaluating the effects of one session of Action Observation Training (AOT) and Motor Imagery (MI) on arthrogenic muscle inhibition (AMI) of the quadriceps (QF) in subjects with end-stage gonarthrosis.

30 patients with end-stage knee osteoarthritis were enrolled. Patients were randomized in two groups (experimental group and control group).

Experimental group performed one AOT and MI session with motor content of concentric and isometric QF contractions, whereas control group underwent a 6-minute sham AOT and MI session. Every patient was evaluated to assess the percentage of AMI on the QF before (T0) and after (T1) the assigned treatment following the gold standard Twitch Interpolated Technique. Both groups sat on an isometric dynamometric chair (COR1, OT-Bioelettronica, Torino) with a load cell (FORZA, OT-Bioelettronica, Torino) designed to detect and map the strenght generated by the QF muscle. Upper body movements were limited by crossover shoulder harnesses, a belt across the abdomen and the subjects were asked to keep their arms crossed holding onto the harness while performing the evaluation.

Three large electrodes (10x13cm) were positioned over the quadriceps muscle belly. Two sEMG electrodes (FREEEMG, BTS, Italy) were positioned on the Vastus Medialis and Vastus Lateralis using the SENIAM protocol.

Right after the first evaluation (T0), both groups performed an AOT session. The experimental group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb affected) performed, in third person view, quadriceps concentric contractions for 2 minutes and isometric contractions for 2 minutes. The video contained visual elements indicating the maximality of the effort. After both concentric movement video and isometric movement video the subjects performed a MI session (2 sessions, 1 minute in length each), in which they were asked to imagine in first person the action just seen in the video.

On the other hand, the control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute. After the session of AOT and MI (T1) both groups were re-evaluated in the same way as previously described.

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.
Interventional

Enrollment (Estimated)

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.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Rozzano, Italy, 20089

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with end-stage knee ostheoarthritis undergoing primary total knee arthroplasty
  • Active knee flexion > 45°

Exclusion Criteria:

  • Previous lower limb orthopedic surgery
  • Concomitant neurological, orthopedic, cardiovascular disorders
  • Cognitive impairments or psychiatric disorders

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: AOT + MI group
The AOT + MI group was shown a video (4 minutes) in which a subject (matched for age, sex, and limb affected) performed, in third person view, quadriceps concentric contractions for 2 minutes and isometric contractions for 2 minutes. The video contained visual elements indicating the maximality of the effort. After both concentric and isometric movement video the subjects performed a MI session (1 minute in length each), in which they were asked to imagine in first person the action previously observed in the video.
Other: AOT + MI
During the AOT session, the patients were shown a video containing motor contents. In particular, the video demonstrated quadriceps concentric and isometric contractions, presented in the third person perspective. At the conclusion of each video, the patients were asked to spend 1 minute imagining what they had just seen.
Sham Comparator: Control group
The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.
Other: Control AOT + MI
The control group was shown a video of landscapes (4 minutes in length). Halfway through and at the end of the video they were asked to imagine what they had just seen for 1 minute.

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
Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique)
Time Frame: 1- Before AOT+MI session; 2- Immediately after AOT+MI session
Changes in arthrogenic muscle inhibition (AMI) of the quadriceps muscle before and after AOT and MI session on patients with advanced stage gonarthrosis.
1- Before AOT+MI session; 2- Immediately after AOT+MI session

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.
January 1, 2023

Primary Completion (Estimated)

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 30, 2023

Study Completion (Estimated)

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 30, 2023

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).
August 3, 2023

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.
August 16, 2023

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.
August 21, 2023

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.
August 21, 2023

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.
August 16, 2023

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.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CLF22/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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