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Motor Imagery and Rehabilitation of Orthopaedic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370146
Recruitment Status : Unknown
Verified December 2017 by Istituto Ortopedico Galeazzi.
Recruitment status was:  Recruiting
First Posted : December 12, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief 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. The investigators also characterize the brain correlates of such recovery with imagery tasks for virtual reality environments.

Condition or disease Intervention/treatment
Orthopedic Disorder Behavioral: Mental training based on Motor Imagery Behavioral: Cognitive training Behavioral: Evaluation of gait abilities

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 17, 2015
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
TKA patients - Experimental Group Behavioral: Mental training based on Motor Imagery
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.

Behavioral: Evaluation of gait abilities
All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities

TKA patients - Control Group 1 Behavioral: Cognitive training
Patients of the control group 1 will undergo a general cognitive training, not based on motor imagery.

Behavioral: Evaluation of gait abilities
All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities

Healthy subjects - Control Group 2 Behavioral: Evaluation of gait abilities
All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • Right handed
  • No contraindication to the fMRI exam

Exclusion Criteria:

  • Contraindication to the fMRI exam

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370146


Locations
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Italy
IRCCS Galeazzi Orthopedic Hospital Recruiting
Milan, Italy, 20161
Contact: Sara Zacchetti    +390266214057    sara.zacchetti@grupposandonato.it   
Principal Investigator: Eraldo Paulesu         
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03370146    
Other Study ID Numbers: L3020
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases