The Effect of Virtual Reality Training Compared to Traditional Exercise in Patients With Frozen Shoulder

NCT ID: NCT06547073

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Frozen Shoulder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Frozen shoulder group

Patient group

Group Type: EXPERIMENTAL

Virtual reality exercise training

Intervention Type: OTHER

Beat saber

Traditional exercise training

Intervention Type: OTHER

Bench slides, supine active assisted flexion, pendulum exercise, seated active assisted external rotation

Healthy group

Healthy subjects without shoulder pain

Group Type: ACTIVE_COMPARATOR

Virtual reality exercise training

Intervention Type: OTHER

Beat saber

Interventions

Virtual reality exercise training

Beat saber

Intervention Type: OTHER

Traditional exercise training

Bench slides, supine active assisted flexion, pendulum exercise, seated active assisted external rotation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A diagnosis of frozen shoulder/adhesive capsulitis (by a medical doctor) both idiopathic and postoperative/posttraumatic
• The participants need to have:

• a passive ROM restriction (measured using goniometry) at the affected shoulder of 25% or more in at least two directions in comparison to the unaffected shoulder
• an external rotation restriction at the affected shoulder of at least 50% when compared to the unaffected side
• pain and restricted ROM present for at least two months, reaching a plateau or becoming worse
• gradual onset of pain and stiffness
• The participants are allowed to already be in therapy with a physiotherapist and do not have to stop an ongoing therapy in order to participate in the study. The reason for this is that only the short-term effect is being researched
• The participants are allowed to have had an operative treatment if they still have the aforementioned restrictions

Exclusion Criteria

• The presence of contra-indications to perform active shoulder movements
• The presence of neurological conditions
• Systemic disease (e.g. Fibromyalgia, rheumatism, muscle disease…)
• The presence of visual conditions that will not allow performing VR therapy without losing balance
• A pathology of the back of lower limbs which do not allow the performance of exercise in standing position
• A higher risk of falling with at least one fall during the past year
• Insufficient control of the Dutch language

• shoulder pain in the last 6 months
• prior shoulder surgery
• fractures of the upper arm or scapula
• systemic disease (e.g. Fibromyalgia, rheumatism, muscle disease…)
• the presence of contra-indications to perform active shoulder movements (e.g. recent elbow surgery), balance disorders (e.g. benign paroxysmal positional vertigo), visual disorders (e.g. severe reduced vision or visual acuity)
• any pathology in the back/lower limbs that prevents standing exercises from being performed
• increased risk of falls with at least one fall incident in the past year
• insufficient knowledge of the Dutch language.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Annelies Maenhout, PhD

Role: CONTACT

annelies.maenhout@ugent.be

0032473806159

Facility Contacts

Annelies Maenhout, PhD

Role: primary

annelies.maenhout@ugent.be

0032473806159

Other Identifiers

ONZ-2023-0381

Identifier Type: -

Identifier Source: org_study_id