Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
Primary Purpose
Hip Osteoarthritis, Orthopedic Disorder
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Action observation therapy
motor imagery
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Action observation therapy, motor imagery, Hip arthroplasty, functional recovery
Eligibility Criteria
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
Sites / Locations
- Istituto Clinico Humanitas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AOT+MI
Control group
Arm Description
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.
Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in maximum gait speed
Changes in maximum gait speed between and within groups will be evaluated with 10 meters-walking test (10 MWT).
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)
Full Information
NCT ID
NCT05188560
First Posted
December 20, 2021
Last Updated
March 3, 2022
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT05188560
Brief Title
Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
Official Title
Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Orthopedic Disorder
Keywords
Action observation therapy, motor imagery, Hip arthroplasty, functional recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AOT+MI
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too.
Intervention Type
Other
Intervention Name(s)
Action observation therapy
Intervention Description
Subject is asked to observe videos with motor contents
Intervention Type
Other
Intervention Name(s)
motor imagery
Intervention Description
mental simulation of a motor task
Primary Outcome Measure Information:
Title
Changes in functional mobility using Timed Up and Go test (TUG).
Description
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.
Time Frame
Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Secondary Outcome Measure Information:
Title
Changes in maximum gait speed
Description
Changes in maximum gait speed between and within groups will be evaluated with 10 meters-walking test (10 MWT).
Time Frame
Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Title
Changes in pain using Visual Analogue Scale (VAS)
Description
Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)
Time Frame
Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
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