Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis: (LOARAL 2) (LOARAL 2)

January 30, 2024 updated by: Poitiers University Hospital

Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis

The LOARAL 2 project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into three groups: a control group where patients will do standard rehabilitation associated with the judgments of videos represented non-human action and two experimental groups where patients will do standard rehabilitation associated with the judgement of human point-light display. The aim of this study is to measure the benefits of attentional focus and sex correspondence in the use of point-light display for the rehabilitation of patients with a total arthroplasty of the knee.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteers over 18 years of age who have undergone knee surgery

Exclusion Criteria:

  • Any locomotor condition not due to knee surgery
  • Uncorrected visual disturbances
  • Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism)

Non randomization criteria:

  • Cognitive disorders (Mini Mental State Examination <21)
  • Depressive disorders (Beck Inventory index> 9)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Control group who will do usual rehabilitation + visualization of videos representing monuments + a 3-meter round-trip walk
Experimental: Experimental group 1
Experimental group 1 who will do usual rehabilitation + visualization of non focused point-light human actions + a 3-meter round-trip walk
Other: Point light display
Visualization of point-light human actions
Experimental: Experimental group 2
Experimental group 2 who will do usual rehabilitation + visualization of focused point-light human actions + a 3-meter round-trip walk
Other: Point light display
Visualization of point-light human actions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The score obtained on the Western Ontario and McMaster (WOMAC) test at inclusion and at the end of the program.
Time Frame: Rehabilitation during 3 weeks
Rehabilitation during 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-A03000-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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