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

Primary Purpose

Knee Osteoarthritis, Arthrogenic Muscle Inhibitions

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AOT + MI
Control AOT + MI
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Clinico HumanitasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AOT + MI group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique)
Changes in arthrogenic muscle inhibition (AMI) of the quadriceps muscle before and after AOT and MI session on patients with advanced stage gonarthrosis.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 16, 2023
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT06000345
Brief Title
Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.
Official Title
Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthrogenic Muscle Inhibitions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AOT + MI group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
AOT + MI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control AOT + MI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique)
Description
Changes in arthrogenic muscle inhibition (AMI) of the quadriceps muscle before and after AOT and MI session on patients with advanced stage gonarthrosis.
Time Frame
1- Before AOT+MI session; 2- Immediately after AOT+MI session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Gatti
Phone
0282245610
Email
roberto.gatti@hunimed.eu
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
roberto gatti
Phone
0282245610
Email
roberto.gatti@hunimed.eu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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