Knee OsteoarthritisNCT06000345
Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.
A study testing AOT + MI in people with Knee Osteoarthritis and Arthrogenic Muscle Inhibitions, run by Istituto Clinico Humanitas at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Arthrogenic Muscle Inhibitions
- What is being tested?
- AOT + MI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with end-stage knee ostheoarthritis undergoing primary total knee arthroplasty
- Active knee flexion > 45°
Who cannot join
- Previous lower limb orthopedic surgery
- Concomitant neurological, orthopedic, cardiovascular disorders
- Cognitive impairments or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, 20089
roberto gatti, 0282245610, roberto.gatti@hunimed.eu
About this study
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.
Read the 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.
- Being tested
- AOT + MI, Control AOT + MI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOT + MIOther
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 + MIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AOT + MI group | Experimental | 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. Receives: Other: AOT + MI |
| Control group | Sham comparator | 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. Receives: Other: Control AOT + MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1- Before AOT+MI session; 2- Immediately after AOT+MI session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000345
- Sponsor's protocol ID
- CLF22/07
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Action Observation and Motor Imagery on Arthrogenic Muscle Inhibition of the Quadriceps in Patients With End-stage Knee Gonarthrosis.
- ClinicalTrials.gov ID
- NCT06000345
- Acronym / sponsor ID
- CLF22/07
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOT + MI group | Experimental | Other: AOT + MIThe 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. |
| Control group | Sham comparator | Other: Control AOT + MIThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with end-stage knee ostheoarthritis undergoing primary total knee arthroplasty
- Active knee flexion > 45°
Key exclusion criteria (3 listed)
- Previous lower limb orthopedic surgery
- Concomitant neurological, orthopedic, cardiovascular disorders
- Cognitive impairments or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AOT + MIDuring 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. | Other | AOT + MI group |
| Control AOT + MIThe 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 group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOT + MI in people with Knee Osteoarthritis and Arthrogenic Muscle Inhibitions, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Gatti (0282245610, roberto.gatti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in arthrogenic muscle inhibition (estimated through Interpolated Twitch Technique) (time frame: 1- Before AOT+MI session; 2- Immediately after AOT+MI session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.