Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis. (LOARAL)

September 28, 2021 updated by: Poitiers University Hospital
The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the judgement of point-light display. The aim of this study is to validate the use of point-light display for the Rehabilitation of patients with a totalarthroplasty of the knee.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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 Locations

      • Poitiers, France
        • Centre Hospitalier Universitaire

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

Genders Eligible for Study

All

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)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Control group who will do usual rehabilitation.
EXPERIMENTAL: Experimental group
Experimental group who will do usual rehabilitation and visualization of point-light human actions
Experimental group who will do usual rehabilitation and visualization of point-light human actions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the evaluation of the point light display relative to conventional rehabilitation
Time Frame: Rehabilitation during 3 weeks
The time to realize the time up and go test will be assessed at inclusion and at the end of the program.
Rehabilitation during 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the evaluation of the point light display on functional recovery
Time Frame: At the end of the program (3 weeks max)
Test score the time up and go and test score questionnary WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index, Bellamy et al., 1988).
At the end of the program (3 weeks max)
Compare the evaluation of the point light display on the detection and action recognition
Time Frame: At the end of the program (3 weeks max)
Percentages of correct recognition of actions on the point light display
At the end of the program (3 weeks max)
Compare the evaluation of the point light display on the feeling of self-efficacy personal
Time Frame: At the end of the program (3 weeks max)
Test score questionnary of self-efficacy personal (Dumont et al., 2000).
At the end of the program (3 weeks max)

Collaborators and Investigators

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

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)

January 14, 2020

Primary Completion (ACTUAL)

June 25, 2021

Study Completion (ACTUAL)

June 25, 2021

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (ACTUAL)

February 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-A00450-57

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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