NCT05459766

Brief Summary

The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 12, 2022

Last Update Submit

July 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in functional mobility

    It will be assessed using the Timed Up and Go test

    At baseline, at 1 day and 3 days after surgery

Secondary Outcomes (4)

  • Changes in active and passive knee range of motion

    At baseline, at 1 day and 3 days after surgery

  • Changes in perceived pain

    At baseline and 3 days after surgery

  • Changes in body pain representation at the level of the knee joint

    At baseline and 3 days after surgery

  • Changes in quadriceps activation failure

    At baseline, at 1 day and 3 days after surgery

Study Arms (2)

AO+MI

EXPERIMENTAL

Video-clips observation representing motor contents, followed by motor imagery (12 minutes a day per 3 days).

Behavioral: Action observation and motor imagery

CTRL

ACTIVE COMPARATOR

Usual care, consisting of preoperative education.

Behavioral: Usual care

Interventions

Observation and imagination of functional tasks that will be performed during the postoperative rehabilitation program.

AO+MI
Usual careBEHAVIORAL

Participants will be educated about the postoperative rehabilitation program

CTRL

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for total knee arthroplasty
  • age greater or equal to 18 years old
  • ability to walk independently.

You may not qualify if:

  • previous total knee arthoplasty on the contralateral side
  • revision surgery
  • dementia
  • musculoskeletal and neurological disorders influencing functional recovery
  • visual or auditory deficits.
  • postoperative complications
  • weight bearing restrictions
  • lack of walking independency within the second postoperative day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

August 1, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share