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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03856983
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.
• Actual Study Start Date: Jan 14, 2020
• Actual Primary Completion Date: Jun 25, 2021
• Actual Study Completion Date: Jun 25, 2021

Arms and Interventions

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	Other: Point light display; Experimental group who will do usual rehabilitation and visualization of point-light human actions

Outcome Measures

Primary Outcome Measures

1. Compare the evaluation of the point light display relative to conventional rehabilitation [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.

Secondary Outcome Measures

1. Compare the evaluation of the point light display on functional recovery [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).

2. Compare the evaluation of the point light display on the detection and action recognition [At the end of the program (3 weeks max)]

   Percentages of correct recognition of actions on the point light display

3. Compare the evaluation of the point light display on the feeling of self-efficacy personal [At the end of the program (3 weeks max)]

   Test score questionnary of self-efficacy personal (Dumont et al., 2000).

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire	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: NCT03856983
• Other Study ID Numbers: 2019-A00450-57
• First Posted: Feb 27, 2019
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• 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 Sep 29, 2021