The Effect of Virtual Reality Training Compared to Traditional Exercise in Patients With Frozen Shoulder
NCT Number: NCT06547073
Acronym: VR4shoulder
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frozen Shoulder
Interventions: OTHER: Virtual reality exercise training|OTHER: Traditional exercise training
Sponsor: University Ghent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-08
Completion Date: 2025-12-31
Locations: Ghent University, Ghent, 9000, Belgium

Summary:
Background: Virtual reality (VR) technology sees a rising appearance in clinical settings, and can be used for physical rehabilitation of the shoulder joint. The immersive virtual world created by VR games can be a distraction of the limitations and hindrances a patient experiences when exercising. Frozen shoulder (FS) or adhesive capsulitis is one of such instances of shoulder pathologies where pain and limited range of motion (ROM) are prev-alent and long lasting. VR could be an option to further help rehabilitate patients with FS.

Objectives: This study aims to investigate 3D upper limb kinematics of a FS patient during VR gaming and to compare these to the unaffected side, as well as to healthy participants. Additionally, this study also aims to compare the effects of a single session of VR gaming and traditional exercise training in patients with frozen shoulder on pain, ROM and shoulder strength as well as the participant's personal experience.

Study design: Cross sectional (3D kinematics) and randomized cross-over design (VR versus traditional exercise) Method: Patients with frozen shoulder (n=15) will be recruited through physical therapy practices and social media. Healthy subjects (n=30) will be recruited on social media. Both groups will play a VR game (Beat saber) will collecting 3D kinematic data of the upper limb with inertial measurement sensors (IMU's). Patients will be evaluated clinically before and after the VR session. The patient group will also perform a control intervention (traditional exercise program) and the same clinical evaluation will be performed before and after this session. Clinical evaluation will consist of shoulder range of motion measurment using a goniometer, pain evaluation using the visual analogue scale (VAS) and shoulder strength evaluation using a hand-held dynamometer (HHD). The order of sessions will be randomized for the patients. At the end of the study, both the healthy and patient group will be interviewed to report on their personal experiences with the VR intervention.

Outcome: 3D kinematics of the upper limb while playing a VR game will be compared between healthy and patient group to evaluate differences. In the patient group, the clinical effect of a single VR session will be compared to a single traditional exercise session.

Primary Outcome Measures: 3D upper limb kinematics, Noraxon IMU, During VR session (both groups) - Day 1
Secondary Outcome Measures: Shoulder range of motion, Goniometer, Immediately before and after both interventions (patients group) - Day 1|Shoulder strength, Hand held dynamometer, Immediately before and after both interventions (patients group) - Day 1|Shoulder pain, VAS, Immediately before and after both interventions (patients group) - Day 1|Personal experience with VR session, Interview, Immediately before and after both interventions (patients group) - Day 1