NCT03370146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2015

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

3.4 years

First QC Date

November 29, 2017

Last Update Submit

December 12, 2017

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

TKA patients - Experimental Group

Behavioral: Mental training based on Motor ImageryBehavioral: Evaluation of gait abilities

TKA patients - Control Group 1

Behavioral: Cognitive trainingBehavioral: Evaluation of gait abilities

Healthy subjects - Control Group 2

Behavioral: Evaluation of gait abilities

Interventions

Mental training based on Motor ImageryBEHAVIORAL

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.

TKA patients - Experimental Group
Cognitive trainingBEHAVIORAL

Patients of the control group 1 will undergo a general cognitive training, not based on motor imagery.

TKA patients - Control Group 1
Evaluation of gait abilitiesBEHAVIORAL

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

Healthy subjects - Control Group 2TKA patients - Control Group 1TKA patients - Experimental Group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Right handed
  • No contraindication to the fMRI exam

You may not qualify if:

  • Contraindication to the fMRI exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 12, 2017

Study Start

March 17, 2015

Primary Completion

July 30, 2018

Study Completion

October 30, 2018

Last Updated

December 13, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)