Orthopedic DisorderNCT03358160
Motor Representations in Orthopedic Patients
An observational study of Orthopedic Disorder and Motor Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The aim of this study is to investigate the possible effects that a motor limitation at the peripheral level might have on the ability to visually discriminate others' actions. Previous literature has shown that specific motor skills (motor expertise) facilitate the visual discrimination of domain-specific actions… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder, Motor Disorder, Perceptual Disorders
- What is being tested?
- Action discrimination tasks.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2016to 30 Dec 2018
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Orthopaedic patients and age-matched healthy controls.
Who may be able to join
- Participants must be able to understand instructions and have no history of neurological or psychiatric disorders.
Who cannot join
- History of neurological or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Galeazzi Orthopedic Hospital
Milan, 20161
Sara Zacchetti, +390266214057, sara.zacchetti@grupposandonato.it
Eraldo Paulesu, MD
About this study
Official title: Motor Representations in Orthopedic Patients: Pilot Studies
The aim of this study is to investigate the possible effects that a motor limitation at the peripheral level might have on the ability to visually discriminate others' actions.
Previous literature has shown that specific motor skills (motor expertise) facilitate the visual discrimination of domain-specific actions, and that these motor experts' superior abilities might be mediated by areas not only responsible for the visual recognition of movements (as it happens in non-expert subjects) but also involved in motor planning. Similarly, impairment in the motor system due to neurological damage modulates not only the ability to perform movements but also the ability to discriminate and predict the temporal course of observed actions.
Read more
Based on these findings, it has been hypothesized that the motor representations of gait, despite being a hyper-learned motor pattern, might be subjected to modification as a result of an impairment of walking caused by a peripheral functional limitation in the lower limbs as the one characterizing orthopaedic patients who underwent a surgical operation for total knee arthroprosthesis. In this protocol, patients are thus required to perform visual discrimination tasks based on the observation of movements performed with either the upper or lower limbs, and their performance is expected to correlated with their functional impairments in movement execution.
These results would indicate that the (in)ability to perform a movement might have an impact on its representation at the central level and on internal motion simulation capabilities, which also influence the ability to visual discriminate others' actions through action-perception transfer: this would suggest that rehabilitation in orthopaedic patients should take into account (and restore) such a central impairment in motor representations.
- Conditions
- Orthopedic Disorder, Motor Disorder, Perceptual Disorders
- Being tested
- Action discrimination tasks.
- Medical subject headings
- Musculoskeletal Diseases, Motor Disorders, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action discrimination tasks.Behavioural
The investigators will compare the groups' performance during action discrimination tasks related to movements of the upper vs. lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| TKA | Orthopaedic patients who underwent surgical operation for total knee arthroprothesis. Receives: Behavioral: Action discrimination tasks. | |
| Rizoarthrosis | Orthopaedic patients who underwent surgical operation to treat chronic arthrosis of the thumb. Receives: Behavioral: Action discrimination tasks. | |
| Healthy Controls | Healthy age-matched controls. Receives: Behavioral: Action discrimination tasks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group Differences in action discrimination performance.
Group Differences in action discrimination performance depending on the impairment in movement execution.
Measured: End 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start31 May 2016
- Primary completion30 Mar 2017
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358160
- Sponsor's protocol ID
- RMPO
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Representations in Orthopedic Patients: Pilot Studies
- ClinicalTrials.gov ID
- NCT03358160
- Acronym / sponsor ID
- RMPO
- Conditions
- Orthopedic Disorder, Motor Disorder, Perceptual Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 30 Nov 2017 (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 aim of this study is to investigate the possible effects that a motor limitation at the peripheral level might have on the ability to visually discriminate others' actions.
Previous literature has shown that specific motor skills (motor expertise) facilitate the visual discrimination of domain-specific actions, and that these motor experts' superior abilities might be mediated by areas not only responsible for the visual recognition of movements (as it happens in non-expert subjects) but also involved in motor planning. Similarly, impairment in the motor system due to neurological damage modulates not only the ability to perform movements but also the ability to discriminate and predict the temporal course of observed actions.
Based on these findings, it has been hypothesized that the motor representations of gait, despite being a hyper-learned motor pattern, might be subjected to modification as a result of an impairment of walking caused by a peripheral functional limitation in the lower limbs as the one characterizing orthopaedic patients who underwent a surgical operation for total knee arthroprosthesis. In this protocol, patients are thus required to perform visual discrimination tasks based on the observation of movements performed with either the upper or lower limbs, and their performance is expected to correlated with their functional impairments in movement execution.
These results would indicate that the (in)ability to perform a movement might have an impact on its representation at the central level and on internal motion simulation capabilities, which also influence the ability to visual discriminate others' actions through action-perception transfer: this would suggest that rehabilitation in orthopaedic patients should take into account (and restore) such a central impairment in motor representations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TKA | – | Behavioral: Action discrimination tasks.Orthopaedic patients who underwent surgical operation for total knee arthroprothesis. |
| Rizoarthrosis | – | Behavioral: Action discrimination tasks.Orthopaedic patients who underwent surgical operation to treat chronic arthrosis of the thumb. |
| Healthy Controls | – | Behavioral: Action discrimination tasks.Healthy age-matched controls. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic patients and age-matched healthy controls.
Key inclusion criteria (1 listed)
- Participants must be able to understand instructions and have no history of neurological or psychiatric disorders.
Key exclusion criteria (1 listed)
- History of neurological 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 |
|---|---|---|
| Action discrimination tasks.The investigators will compare the groups' performance during action discrimination tasks related to movements of the upper vs. lower limbs. | Behavioural | Healthy Controls, Rizoarthrosis, TKA |
Primary outcome
Group Differences in action discrimination performance.
Time frame: End 2018.
Group Differences in action discrimination performance depending on the impairment in movement execution.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
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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?
An observational study of Orthopedic Disorder and Motor Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 1 inclusion and 1 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 30 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group Differences in action discrimination performance. (time frame: End 2018.). 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 30 Nov 2017.