NCT05188560

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
Last Updated

March 4, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

December 20, 2021

Last Update Submit

March 3, 2022

Conditions

Keywords

Action observation therapymotor imageryHip arthroplastyfunctional recovery

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

EXPERIMENTAL

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 therapyOther: motor imagery

Control group

NO INTERVENTION

Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too.

Interventions

Subject is asked to observe videos with motor contents

AOT+MI

mental simulation of a motor task

AOT+MI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Osteoarthritis, HipMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesRheumatic Diseases

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

Locations