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OpenTrials
Completed

NCT Number: NCT05188560

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Orthopedic Disorder Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Action observation therapy

Other

Subject is asked to observe videos with motor contents

motor imagery

Other

mental simulation of a motor task

Primary outcomes

  1. Changes in functional mobility using Timed Up and Go test (TUG).

    Time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.

    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 outcomes

  1. Changes in maximum gait speed

    Time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.

    Changes in maximum gait speed between and within groups will be evaluated with 10 meters-walking test (10 MWT).

  2. Changes in pain using Visual Analogue Scale (VAS)

    Time frame: Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.

    Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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