- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856983
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
Conditions
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.
Sponsor
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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