Motor Imagery and Rehabilitation of Orthopaedic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Behavioral: Mental training based on Motor Imagery; Behavioral: Evaluation of gait abilities; Behavioral: Cognitive training

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20161
    • Recruiting
    • IRCCS Galeazzi Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Right handed
• No contraindication to the fMRI exam

Exclusion Criteria:

• Contraindication to the fMRI exam

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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: Evaluation of gait abilities; All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities; Behavioral: Cognitive training; Patients of the control group 1 will undergo a general cognitive training, not based on motor imagery.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	20 days

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2015
• Primary Completion (Anticipated): July 30, 2018
• Study Completion (Anticipated): October 30, 2018

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: L3020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No