Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
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 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedMarch 4, 2022
January 1, 2022
7 months
December 20, 2021
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Changes in maximum gait speed
Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Changes in pain using Visual Analogue Scale (VAS)
Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.
Study Arms (2)
AOT+MI
EXPERIMENTALparticipants who, in addiction to standard rehabilitation program after surgery, underwent a single pre-operative training session of action observation therapy associated with motor imagery.
Control group
NO INTERVENTIONParticipants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
January 12, 2022
Study Start
March 1, 2021
Primary Completion
October 1, 2021
Study Completion
January 1, 2022
Last Updated
March 4, 2022
Record last verified: 2022-01