Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT06547073

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

Led by University Ghent · Updated on 2024-08-09

45

Participants Needed

1

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • A diagnosis of frozen shoulder or adhesive capsulitis by a medical doctor, including idiopathic and postoperative/posttraumatic cases
  • Passive range of motion restriction of 25% or more in at least two directions in the affected shoulder compared to the unaffected side
  • External rotation restriction of at least 50% in the affected shoulder compared to the unaffected side
  • Pain and limited range of motion present for at least two months, reaching a plateau or worsening
  • Gradual onset of pain and stiffness
  • Allowed to be currently receiving physiotherapy without stopping ongoing therapy
  • Allowed to have had surgery if the above restrictions remain present
Not Eligible

You will not qualify if you...

  • Contraindications to active shoulder movements
  • Neurological conditions
  • Systemic diseases such as fibromyalgia, rheumatism, or muscle diseases
  • Visual conditions preventing safe VR therapy due to balance issues
  • Pathologies of the back or lower limbs preventing standing exercises
  • High risk of falling with at least one fall in the past year
  • Insufficient control of the Dutch language
  • For healthy participants: shoulder pain in the last 6 months
  • Prior shoulder surgery
  • Fractures of upper arm or scapula
  • Balance disorders or severe visual impairments
  • Increased risk of falls with at least one fall in the past year

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ghent University

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

A

Annelies Maenhout, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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