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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188560
• Other study ID #: 750
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Musculoskeletal Diseases
• Orthopedic Disorder
• Osteoarthritis, Hip

Intervention

Other:
• Action observation therapy
Subject is asked to observe videos with motor contents
• motor imagery
mental simulation of a motor task

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.