Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty

The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthoplasty
• Intervention / Treatment: Behavioral: Action observation and motor imagery; Behavioral: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients scheduled for total knee arthroplasty
• age greater or equal to 18 years old
• ability to walk independently.

Exclusion Criteria:

• previous total knee arthoplasty on the contralateral side
• revision surgery
• dementia
• musculoskeletal and neurological disorders influencing functional recovery
• visual or auditory deficits.
• postoperative complications
• weight bearing restrictions
• lack of walking independency within the second postoperative day.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AO+MI; Video-clips observation representing motor contents, followed by motor imagery (12 minutes a day per 3 days).	Behavioral: Action observation and motor imagery; Observation and imagination of functional tasks that will be performed during the postoperative rehabilitation program.
ACTIVE_COMPARATOR: CTRL; Usual care, consisting of preoperative education.	Behavioral: Usual care; Participants will be educated about the postoperative rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functional mobility	It will be assessed using the Timed Up and Go test	At baseline, at 1 day and 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in active and passive knee range of motion	It will be assessed using an inertial measurement unit	At baseline, at 1 day and 3 days after surgery
Changes in perceived pain	It will be assessed using Numerical Rating Scale (0-10 points), where 0 means no pain and 10 means maximum pain.	At baseline and 3 days after surgery
Changes in body pain representation at the level of the knee joint	It will be assessed using the Pain Drawing Body Chart	At baseline and 3 days after surgery
Changes in quadriceps activation failure	It will be assessed using the Quadricpes Activation Battery	At baseline, at 1 day and 3 days after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): January 31, 2023
• Study Completion (ANTICIPATED): January 31, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (ACTUAL): July 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CLF22/06

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