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

Last updated: August 6, 2024
Sponsor: University Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bursitis

Treatment

Virtual reality exercise training

Traditional exercise training

Clinical Study ID

NCT06547073
ONZ-2023-0381
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

PATIENT GROUP (frozen shoulder

Inclusion Criteria:

  • A diagnosis of frozen shoulder/adhesive capsulitis (by a medical doctor) bothidiopathic and postoperative/posttraumatic

  • The participants need to have:

  • a passive ROM restriction (measured using goniometry) at the affected shoulderof 25% or more in at least two directions in comparison to the unaffectedshoulder

  • an external rotation restriction at the affected shoulder of at least 50% whencompared to the unaffected side

  • pain and restricted ROM present for at least two months, reaching a plateau orbecoming worse

  • gradual onset of pain and stiffness

  • The participants are allowed to already be in therapy with a physiotherapist and donot have to stop an ongoing therapy in order to participate in the study. The reasonfor this is that only the short-term effect is being researched

  • The participants are allowed to have had an operative treatment if they still havethe aforementioned restrictions

Exclusion

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 withoutlosing balance

  • A pathology of the back of lower limbs which do not allow the performance ofexercise in standing position

  • A higher risk of falling with at least one fall during the past year

  • Insufficient control of the Dutch language

HEALTHY GROUP Exclusion criteria

  • 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. recentelbow 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 beingperformed

  • increased risk of falls with at least one fall incident in the past year

  • insufficient knowledge of the Dutch language.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Virtual reality exercise training
Phase:
Study Start date:
April 08, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Ghent University

    Ghent, 9000
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.