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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06000345
Other study ID # CLF22/07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date September 30, 2023

Study information

Verified date August 2023
Source Istituto Clinico Humanitas
Contact Roberto Gatti
Phone 0282245610
Email roberto.gatti@hunimed.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Italy Istituto Clinico Humanitas Rozzano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1- Before AOT+MI session; 2- Immediately after AOT+MI session
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