Orthopedic DisorderNCT03370146
Motor Imagery and Rehabilitation of Orthopaedic Patients
An observational study of Orthopedic Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. 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
- What is being tested?
- Mental training based on Motor Imagery, Cognitive training and Evaluation of gait abilities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 17 Mar 2015to 30 Oct 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: Experimental group (MI training): 24 candidates to TKA (aged between 45 and 65 years) will undergo a specific MI training during the period of post-surgical rehabilitation, in addition to the usual physical rehabilitation. Control group 1 (non-specific cognitive training): 24 candidates to TKA will undergo a non-specific cognitive treatment during the period of post-surgical rehabilitation, in addition to the usual physical rehabilitation. Control group 2: 48 subjects with similar demographic characteristics to those of the previous two groups will be evaluated with the same cognitive/fMRI paradigm to assess in TKA candidates the presence of anomalies of cortical organization of the motor system in the pre-surgical phase.
Who may be able to join
- Right handed
- No contraindication to the fMRI exam
Who cannot join
- Contraindication to the fMRI exam
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
About this study
Official title: Can Mental Training Based on Motor Imagery Speed up the Rehabilitation of Walking? Efficacy of a Controlled Procedure and Neurofunctional Bases of Recovery in Patients With Total Knee Arthroplasty
Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.
- Conditions
- Orthopedic Disorder
- Being tested
- Mental training based on Motor Imagery, Cognitive training, Evaluation of gait abilities
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental training based on Motor ImageryBehavioural
Patients of the experimental group will be instructed to imagine walking, from a first person perspective, focusing on the kinaesthetic sensations typically associated with the movement. The motor imagery training will be performed using the support of a laptop, on which there will be presented complex static scenes, representing different kind of paths with different landmarks to reach during the mental walking.
Cognitive trainingBehavioural
Patients of the control group 1 will undergo a general cognitive training, not based on motor imagery.
Evaluation of gait abilitiesBehavioural
All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities
| Study group | Role | What they receive |
|---|---|---|
| TKA patients - Experimental Group | Not described Receives: Behavioral: Mental training based on Motor Imagery; Behavioral: Evaluation of gait abilities | |
| TKA patients - Control Group 1 | Not described Receives: Behavioral: Cognitive training; Behavioral: Evaluation of gait abilities | |
| Healthy subjects - Control Group 2 | Not described Receives: Behavioral: Evaluation of gait abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of walking
The speed of walking recorded in total knee arthroplasty patients of the experimental group will be compared with the same measure recorded in both control groups.
Measured: 20 days
BOLD (blood oxygen level-dependent) activity
The BOLD activity recorded during functional magnetic resonance imaging (fMRI) in TKA patients of the experimental group will be compared with the same measure recorded in both control groups.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start17 Mar 2015
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Oct 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.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT03370146
- Sponsor's protocol ID
- L3020
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 13 Dec 2017
- Results posted
- 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 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mental Training Based on Motor Imagery Speed up the Rehabilitation of Walking? Efficacy of a Controlled Procedure and Neurofunctional Bases of Recovery in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03370146
- Acronym / sponsor ID
- L3020
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 12 Dec 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.
Motor imagery is increasingly used as a plasticity-booster to complement conventional rehabilitation. Here the investigators test the hypothesis that the combination of mental training with conventional rehabilitation may speed up the recovery in patients with total knee arthroplasty. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TKA patients - Experimental Group | – | Behavioral: Mental training based on Motor Imagery, Behavioral: Evaluation of gait abilities |
| TKA patients - Control Group 1 | – | Behavioral: Cognitive training, Behavioral: Evaluation of gait abilities |
| Healthy subjects - Control Group 2 | – | Behavioral: Evaluation of gait abilities |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Experimental group (MI training): 24 candidates to TKA (aged between 45 and 65 years) will undergo a specific MI training during the period of post-surgical rehabilitation, in addition to the usual physical rehabilitation. Control group 1 (non-specific cognitive training): 24 candidates to TKA will undergo a non-specific cognitive treatment during the period of post-surgical rehabilitation, in addition to the usual physical rehabilitation. Control group 2: 48 subjects with similar demographic characteristics to those of the previous two groups will be evaluated with the same cognitive/fMRI paradigm to assess in TKA candidates the presence of anomalies of cortical organization of the motor system in the pre-surgical phase.
Key inclusion criteria (2 listed)
- Right handed
- No contraindication to the fMRI exam
Key exclusion criteria (1 listed)
- Contraindication to the fMRI exam
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 |
|---|---|---|
| Mental training based on Motor ImageryPatients of the experimental group will be instructed to imagine walking, from a first person perspective, focusing on the kinaesthetic sensations typically associated with the movement. The motor imagery training will be performed using the support of a laptop, on which there will be presented complex static scenes, representing different kind of paths with different landmarks to reach during the mental walking. | Behavioural | TKA patients - Experimental Group |
| Cognitive trainingPatients of the control group 1 will undergo a general cognitive training, not based on motor imagery. | Behavioural | TKA patients - Control Group 1 |
| Evaluation of gait abilitiesAll the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities | Behavioural | Healthy subjects - Control Group 2, TKA patients - Control Group 1, TKA patients - Experimental Group |
Primary outcome
Speed of walking
Time frame: 20 days
The speed of walking recorded in total knee arthroplasty patients of the experimental group will be compared with the same measure recorded in both control groups.
BOLD (blood oxygen level-dependent) activity
Time frame: 20 days
The BOLD activity recorded during functional magnetic resonance imaging (fMRI) in TKA patients of the experimental group will be compared with the same measure recorded in both control groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- 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?
An observational study of Orthopedic 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 2 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 13 Dec 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?
Speed of walking (time frame: 20 days). The study lists 2 primary outcomes in all. 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 13 Dec 2017.