Clinical trial NCT06963983: Virtual Reality Rehabilitation for Shoulder Pathologies
Official title: Personalized Rehabilitation System Using Gamification With Virtual Reality Technology: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Instability
Frozen Shoulder
Rotator Cuff Tears
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most rehabilitation protocols require patients to train the affected limbs with high regularity, following repetitive cycles of exercises, in order to recover mobility and strength. Nonetheless, the repetitive nature of these exercises can demotivate patients leading to less intense and committed training, if not ending with a lack of compliance toward the prescribed exercises, ultimately leading to a suboptimal recovery. For this reason, several research groups are investigating solutions to help patients in this process, using robotic support or protocols assisted by virtual reality (VR).

Most of these studies have shown benefits, notably in the field of post-stroke rehabilitation, however numerous types of physical therapies have not been investigated yet. Therefore, the main goal of this study will be to explore if the combination of modern motion-tracking and VR can provide significant functional outcomes for the treatment of the most common upper limb pathologies. The investigators created a set of exergames designed to lead the patients through a gamified version of part of physiotherapy (PT). This modified therapy is expected to offer several benefits to the treatment with respect to a purely conventional therapy: (i) improved patient's motivation and commitment to the exercises; (ii) constant evaluation of the patient's performance, thanks to the use of motion tracking; (iii) session-by-session tuning of exercises difficulty; (iv) clear progress traceability; (v) real-time alerts in case of problematic or compensatory movements; (vi) measurement and evaluation of new metrics of movements quality that were not possible in conventional therapy setups.

To evaluate the feasibility of this project, the investigators would like to test the VR system on a short series of patients during four sessions.


Eligibility criteria: Inclusion Criteria:

* Adult patients able to understand the content of the patient information / consent form and give consent to take part in the research project
* Glenohumeral instability surgical treated with traumatic initial instability in a \< 20 years old athlete, recurrent instability with one or more of the following criteria: a failure of conservative treatment, locked dislocation, failed prior surgery, high risk for further recurrence (i.e. collision or competitive athletes), Critical glenoid bone-loss (\>15-20%), bipolar bone-loss resulting in "off-track" lesion
* Partial or complete rotator cuff repair with an indication to postoperative rehabilitation depending on surgeon recommendation
* Idiopathic, primary, or secondary frozen shoulder

Exclusion Criteria:

* Patients with a language barrier hindering questionnaires completion
* Patients unlikely to attend clinical follow-up (e.g. when living abroad)
* Legal incompetence
* Enrolment of the investigators, his/her family members, employees and other dependent persons
* Non-motivated patients
* Active infection
* Exclusion criteria related to glenohumeral instability: uncontrolled epilepsy, spontaneous unidirectional instability in a hyperlax patient, multidirectional instability, elher-Danlos syndrome
* Exclusion criteria related to rotator cuff tears: Additional procedure(s) (muscle transfer, patch,...)
* Exclusion criteria related to VR use: Patients with a predisposition to motion sickness, Patients suffering from epilepsy or having any serious mental illness (schyzophrenia, neurological problems, etc.), Patients with visual impairment , Patients will intellectual disability that prevent them to understand how to use the VR rehabilitation system, Patients with bilateral upper limb injuries, as one side is needed as healthy reference

Primary outcomes:
measure: Simulator Sickness Questionnaire
timeFrame: Day 1
Secondary outcomes:
measure: A reduced version of the Post-experimental Intrinsic Motivation Inventory
timeFrame: Day 1
measure: A reduced version of the Avatar Embodiment Questionnaire
timeFrame: Day 1
measure: Patient satisfaction
timeFrame: Day 1
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: La Tour hospital
state: Geneva
Study officials:
affiliation: La Tour hospital, Meyrin (1217) Geneva, Switzerland
name: Alexandre Lädermann, MD
role: PRINCIPAL_INVESTIGATOR
References: