NCT03856983

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

February 20, 2019

Last Update Submit

September 28, 2021

Conditions

Knee SurgeryRehabilitationPoint Light Display

Outcome Measures

Primary Outcomes (1)

  • Compare the evaluation of the point light display relative to conventional rehabilitation

    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 Outcomes (3)

  • Compare the evaluation of the point light display on functional recovery

    At the end of the program (3 weeks max)

  • Compare the evaluation of the point light display on the detection and action recognition

    At the end of the program (3 weeks max)

  • Compare the evaluation of the point light display on the feeling of self-efficacy personal

    At the end of the program (3 weeks max)

Study Arms (2)

Control group

NO INTERVENTION

Control group who will do usual rehabilitation.

Experimental group

EXPERIMENTAL

Experimental group who will do usual rehabilitation and visualization of point-light human actions

Other: Point light display

Interventions

Point light displayOTHER

Experimental group who will do usual rehabilitation and visualization of point-light human actions

Experimental group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Poitiers, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 27, 2019

Study Start

January 14, 2020

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

FR(1)