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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05297539
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 18.8
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Surgery; Rehabilitation; Point Light Display	Other: Point light display	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Optimization of the Role of Action Observation in the Post-operative Rehabilitation of the Total Knee Prosthesis
• Actual Study Start Date: Jun 14, 2022
• Anticipated Primary Completion Date: Jan 6, 2024
• Anticipated Study Completion Date: Jan 6, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Poitiers	Poitiers		France

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT05297539
• Other Study ID Numbers: 2021-A03000-41
• First Posted: Mar 28, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 13, 2022