NCT05297539

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 14, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

March 17, 2022

Last Update Submit

April 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The score obtained on the Western Ontario and McMaster (WOMAC) test at inclusion and at the end of the program.

    Rehabilitation during 3 weeks

Study Arms (3)

Control Group

NO INTERVENTION

Control group who will do usual rehabilitation + visualization of videos representing monuments + a 3-meter round-trip walk

Experimental group 1

EXPERIMENTAL

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

Experimental group 2

EXPERIMENTAL

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

Interventions

Visualization of point-light human actions

Experimental group 1Experimental group 2

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)
  • Non randomization criteria:
  • Cognitive disorders (Mini Mental State Examination \<21)
  • Depressive disorders (Beck Inventory index\> 9)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Poitiers

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

March 17, 2022

First Posted

March 28, 2022

Study Start

June 14, 2022

Primary Completion

December 6, 2024

Study Completion

December 6, 2024

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations