Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.

Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis; Orthopedic Disorder
• Intervention / Treatment: Other: Action observation therapy; Other: motor imagery

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Total hip arthroplasty (THA) monolateral, first implant
• Locomotor autonomy with or without aids before surgery
• BMI (regular, overweight, Grade I obesity)
• No complications in surgery
• Orthopaedic prescription of tolerance load on the limb
• Autonomy with aids within the third post-operative day

Exclusion Criteria:

• Previous total hip replacement on contralateral hip
• Dementia or other conditions affecting patient's collaboration
• Unresolved clinical complications in the first two post-operative days
• Neurological, musculoskeletal or other disorders able to impact on functional recovery
• Visual or auditory deficits
• Total or partial revisions of THA
• Patients assigned to different groups hospitalized in the same room

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AOT+MI; participants who, in addiction to standard rehabilitation program after surgery, underwent a single pre-operative training session of action observation therapy associated with motor imagery.	Other: Action observation therapy; Subject is asked to observe videos with motor contents; Other: motor imagery; mental simulation of a motor task
No Intervention: Control group; Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functional mobility using Timed Up and Go test (TUG).	The primary outcome is to investigate whether a single administration consisting of two sessions of AOT and MI performed the day before the total hip arthroplasty may impact on functional recovery in the immediate post-operative period. Functional mobility will be evaluated with Timed Up and Go test.	Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in maximum gait speed	Changes in maximum gait speed between and within groups will be evaluated with 10 meters-walking test (10 MWT).	Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Changes in pain using Visual Analogue Scale (VAS)	Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)	Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: motor imagery; Hip arthroplasty; functional recovery; Action observation therapy
• Additional Relevant MeSH Terms: Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Musculoskeletal Diseases
• Other Study ID Numbers: 750

Drug and device information, study documents

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