Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator (APLOSIM)

Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Learning how to perform LP is essentially done at the patient's bed by showing the students how a procedure is performed and then having them perform it directly on a patient afterwards. The recent development of simulation in health care with the credo "never the first time on the patient" requires the development of training devices faithful to reality.

The rheumatology department of the Strasbourg University Hospital has been working for 3 years, in collaboration with the Strasbourg start-up InSimo, on the development of an LP simulator. This simulator is original because it allows the feeling by pressure of the passage of the various structures, and in particular the yellow ligament. This sensation is made possible by a haptic force feedback device.

Study Overview

• Status: Completed
• Conditions: Lumbar Puncture
• Intervention / Treatment: Other: performing lumbar punctures by students with standard training; Other: training students augmented reality simulator

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Requiring a lumbar puncture as part of their routine care
• Male or female of legal age with no upper age limit
• French speaking
• Subject affiliated to a social health insurance scheme
• Not having expressed his or her opposition to the re-use of his or her data in the context of this research

Exclusion criteria:

• Previously undergone a lumbar puncture
• BMI > 35 kg/m².
• Spinal ankylosis: history of ankylosing spondylitis or Forestier's disease
• Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
• Subject under court protection
• Subject under guardianship or curatorship
• Contraindication to the use of Emlapatch

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group patient; performing lumbar punctures by students with standard training	Other: performing lumbar punctures by students with standard training; performance of the puncture by the student have been previously trained with standard training
Experimental: experimental group patient; performing lumbar punctures by students with standard training and an augmented reality simulator	Other: training students augmented reality simulator; performance of the puncture by the student have been previously trained using the augmented reality simulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching.	Success rate of lumbar puncture as assessed by the collection of cerebrospinal fluid (CSF) at the end of the procedure. A successful LP is defined as the collection of CSF at the end of the procedure performed by the student without the assistance of a senior physician or resident and without interruption of the procedure by the patient.	3 days

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Publications and helpful links

General Publications

• Felten R, Bigaut K, Wirth T, Kremer L, Gauer L, Arnold C, Ollivier I, Godet J, Scherlinger M, Dubois M, Sebbag E, De Seze J, Gottenberg JE. Advancing medical training with augmented reality and haptic feedback simulator: outcomes of a randomized controlled trial on lumbar puncture. BMC Med Educ. 2025 Aug 30;25(1):1231. doi: 10.1186/s12909-025-07536-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: lumbar puncture; simulator
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 8074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No