Hip OsteoarthritisNCT05188560
Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
A study testing Action observation therapy and motor imagery in people with Hip Osteoarthritis and Orthopedic Disorder, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Orthopedic Disorder
- What is being tested?
- Action observation therapy and motor imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 1 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip arthroplasty (THA) monolateral, first implant
- Locomotor autonomy with or without aids before surgery
- BMI (regular, overweight, Grade I obesity)
- No complications in surgery
- Orthopaedic prescription of tolerance load on the limb
- Autonomy with aids within the third post-operative day
Who cannot join
- Previous total hip replacement on contralateral hip
- Dementia or other conditions affecting patient's collaboration
- Unresolved clinical complications in the first two post-operative days
- Neurological, musculoskeletal or other disorders able to impact on functional recovery
- Visual or auditory deficits
- Total or partial revisions of THA
- Patients assigned to different groups hospitalized in the same room
Trial locations and contacts
1 site in 1 country.
About this study
Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.
- Conditions
- Hip Osteoarthritis, Orthopedic Disorder
- Being tested
- Action observation therapy, motor imagery
- Keywords
- Action observation therapy, motor imagery, Hip arthroplasty, functional recovery
- Medical subject headings
- Osteoarthritis, Hip, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation therapyOther
Subject is asked to observe videos with motor contents
motor imageryOther
mental simulation of a motor task
| Study group | Role | What they receive |
|---|---|---|
| AOT+MI | Experimental | participants who, in addiction to standard rehabilitation program after surgery, underwent a single pre-operative training session of action observation therapy associated with motor imagery. Receives: Other: Action observation therapy; Other: motor imagery |
| Control group | No intervention | Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional mobility using Timed Up and Go test (TUG).
The primary outcome is to investigate whether a single administration consisting of two sessions of AOT and MI performed the day before the total hip arthroplasty may impact on functional recovery in the immediate post-operative period. Functional mobility will be evaluated with Timed Up and Go test.
Measured: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Secondary outcomes (2)
Changes in maximum gait speed
Changes in maximum gait speed between and within groups will be evaluated with 10 meters-walking test (10 MWT).
Measured: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Changes in pain using Visual Analogue Scale (VAS)
Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)
Measured: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188560
- Sponsor's protocol ID
- 750
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT05188560
- Acronym / sponsor ID
- 750
- Conditions
- Hip Osteoarthritis, Orthopedic Disorder
- Keywords
- Action observation therapy, motor imagery, Hip arthroplasty, functional recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 12 Jan 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.
Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOT+MI | Experimental | Other: Action observation therapy, Other: motor imageryparticipants who, in addiction to standard rehabilitation program after surgery, underwent a single pre-operative training session of action observation therapy associated with motor imagery. |
| Control group | No intervention | –Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Total hip arthroplasty (THA) monolateral, first implant
- Locomotor autonomy with or without aids before surgery
- BMI (regular, overweight, Grade I obesity)
- No complications in surgery
- Orthopaedic prescription of tolerance load on the limb
Key exclusion criteria (7 listed)
- Previous total hip replacement on contralateral hip
- Dementia or other conditions affecting patient's collaboration
- Unresolved clinical complications in the first two post-operative days
- Neurological, musculoskeletal or other disorders able to impact on 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 therapySubject is asked to observe videos with motor contents | Other | AOT+MI |
| motor imagerymental simulation of a motor task | Other | AOT+MI |
Primary outcome
Changes in functional mobility using Timed Up and Go test (TUG).
Time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
The primary outcome is to investigate whether a single administration consisting of two sessions of AOT and MI performed the day before the total hip arthroplasty may impact on functional recovery in the immediate post-operative period. Functional mobility will be evaluated with Timed Up and Go test.
2 secondary outcomes
Changes in maximum gait speed
Time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Changes in pain using Visual Analogue Scale (VAS)
Time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation therapy and motor imagery in people with Hip Osteoarthritis and Orthopedic Disorder, 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 using Timed Up and Go test (TUG). (time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) 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 4 Mar 2022.