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

Exploring the Possibilities of Virtual Reality in Rehabilitation of Patients With Frozen Shoulder

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06547073
Acronym
VR4shoulder
Enrollment
45
Registered
2024-08-09
Start date
2024-04-08
Completion date
2025-12-31
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen Shoulder

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.

Interventions

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

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

PATIENT GROUP (frozen shoulder 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 HEALTHY GROUP

Design outcomes

Primary

MeasureTime frameDescription
3D upper limb kinematicsDuring VR session (both groups) - Day 1Noraxon IMU

Secondary

MeasureTime frameDescription
Shoulder range of motionImmediately before and after both interventions (patients group) - Day 1Goniometer
Shoulder strengthImmediately before and after both interventions (patients group) - Day 1Hand held dynamometer
Shoulder painImmediately before and after both interventions (patients group) - Day 1VAS
Personal experience with VR sessionImmediately before and after both interventions (patients group) - Day 1Interview

Countries

Belgium

Contacts

Primary ContactAnnelies Maenhout, PhD
annelies.maenhout@ugent.be0032473806159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026