Total Knee ArthoplastyNCT05459766
Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty
A study testing Action observation and motor imagery in people with Total Knee Arthoplasty, run by Istituto Clinico Humanitas.
Trial summary
The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Knee Arthoplasty
- What is being tested?
- Action observation and motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Jan 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for total knee arthroplasty
- age greater or equal to 18 years old
- ability to walk independently.
Who cannot join
- previous total knee arthoplasty on the contralateral side
- revision surgery
- dementia
- musculoskeletal and neurological disorders influencing functional recovery
- visual or auditory deficits.
- postoperative complications
- weight bearing restrictions
- lack of walking independency within the second postoperative day.
About this study
The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator.
- Conditions
- Total Knee Arthoplasty
- Being tested
- Action observation and motor imagery, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation and motor imageryBehavioural
Observation and imagination of functional tasks that will be performed during the postoperative rehabilitation program.
Usual careBehavioural
Participants will be educated about the postoperative rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| AO+MI | Experimental | Video-clips observation representing motor contents, followed by motor imagery (12 minutes a day per 3 days). Receives: Behavioral: Action observation and motor imagery |
| CTRL | Active comparator | Usual care, consisting of preoperative education. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional mobility
It will be assessed using the Timed Up and Go test
Measured: At baseline, at 1 day and 3 days after surgery
Secondary outcomes (4)
Changes in active and passive knee range of motion
It will be assessed using an inertial measurement unit
Measured: At baseline, at 1 day and 3 days after surgery
Changes in perceived pain
It will be assessed using Numerical Rating Scale (0-10 points), where 0 means no pain and 10 means maximum pain.
Measured: At baseline and 3 days after surgery
Changes in body pain representation at the level of the knee joint
It will be assessed using the Pain Drawing Body Chart
Measured: At baseline and 3 days after surgery
Changes in quadriceps activation failure
It will be assessed using the Quadricpes Activation Battery
Measured: At baseline, at 1 day and 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthoplastyStudies 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
- 50 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
- NCT05459766
- Sponsor's protocol ID
- CLF22/06
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 19 Jul 2022
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05459766
- Acronym / sponsor ID
- CLF22/06
- Conditions
- Total Knee Arthoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 15 Jul 2022 (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 is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AO+MI | Experimental | Behavioral: Action observation and motor imageryVideo-clips observation representing motor contents, followed by motor imagery (12 minutes a day per 3 days). |
| CTRL | Active comparator | Behavioral: Usual careUsual care, consisting of preoperative education. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for total knee arthroplasty
- age greater or equal to 18 years old
- ability to walk independently.
Key exclusion criteria (8 listed)
- previous total knee arthoplasty on the contralateral side
- revision surgery
- dementia
- musculoskeletal and neurological disorders influencing functional recovery
- visual or auditory deficits.
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 |
|---|---|---|
| Action observation and motor imageryObservation and imagination of functional tasks that will be performed during the postoperative rehabilitation program. | Behavioural | AO+MI |
| Usual careParticipants will be educated about the postoperative rehabilitation program | Behavioural | CTRL |
Primary outcome
Changes in functional mobility
Time frame: At baseline, at 1 day and 3 days after surgery
It will be assessed using the Timed Up and Go test
4 secondary outcomes
Changes in active and passive knee range of motion
Time frame: At baseline, at 1 day and 3 days after surgery
Changes in perceived pain
Time frame: At baseline and 3 days after surgery
Changes in body pain representation at the level of the knee joint
Time frame: At baseline and 3 days after surgery
Changes in quadriceps activation failure
Time frame: At baseline, at 1 day and 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation and motor imagery in people with Total Knee Arthoplasty, run by Istituto Clinico Humanitas.
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 3 inclusion and 8 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional mobility (time frame: At baseline, at 1 day and 3 days after surgery). 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 19 Jul 2022.