Frozen ShoulderVR4shoulderNCT06547073
The Effect of Virtual Reality Training Compared to Traditional Exercise in Patients With Frozen Shoulder
A study testing Virtual reality exercise training and Traditional exercise training in people with Frozen Shoulder, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Virtual reality exercise training and Traditional exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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. 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, 9000
Annelies Maenhout, PhD, 0032473806159, annelies.maenhout@ugent.be
About this study
Official title: Exploring the Possibilities of Virtual Reality in Rehabilitation of Patients With Frozen Shoulder
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.
Read more
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
- Being tested
- Virtual reality exercise training, Traditional exercise training
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exercise trainingOther
Beat saber
Traditional exercise trainingOther
Bench slides, supine active assisted flexion, pendulum exercise, seated active assisted external rotation
| Study group | Role | What they receive |
|---|---|---|
| Frozen shoulder group | Experimental | Patient group Receives: Other: Virtual reality exercise training; Other: Traditional exercise training |
| Healthy group | Active comparator | Healthy subjects without shoulder pain Receives: Other: Virtual reality exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D upper limb kinematics
Noraxon IMU
Measured: During VR session (both groups) - Day 1
Secondary outcomes (4)
Shoulder range of motion
Goniometer
Measured: Immediately before and after both interventions (patients group) - Day 1
Shoulder strength
Hand held dynamometer
Measured: Immediately before and after both interventions (patients group) - Day 1
Shoulder pain
VAS
Measured: Immediately before and after both interventions (patients group) - Day 1
Personal experience with VR session
Interview
Measured: Immediately before and after both interventions (patients group) - Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Apr 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547073
- Sponsor's protocol ID
- ONZ-2023-0381
- Acronym
- VR4shoulder
- Status last verified
- Aug 2024
- First submitted
- 18 Jun 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Possibilities of Virtual Reality in Rehabilitation of Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT06547073
- Acronym / sponsor ID
- VR4shoulder / ONZ-2023-0381
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen shoulder group | Experimental | Other: Virtual reality exercise training, Other: Traditional exercise trainingPatient group |
| Healthy group | Active comparator | Other: Virtual reality exercise trainingHealthy subjects without shoulder pain |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of frozen shoulder/adhesive capsulitis (by a medical doctor) both idiopathic and postoperative/posttraumatic
- The participants need to have:
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exercise trainingBeat saber | Other | Frozen shoulder group, Healthy group |
| Traditional exercise trainingBench slides, supine active assisted flexion, pendulum exercise, seated active assisted external rotation | Other | Frozen shoulder group |
Primary outcome
3D upper limb kinematics
Time frame: During VR session (both groups) - Day 1
Noraxon IMU
4 secondary outcomes
Shoulder range of motion
Time frame: Immediately before and after both interventions (patients group) - Day 1
Shoulder strength
Time frame: Immediately before and after both interventions (patients group) - Day 1
Shoulder pain
Time frame: Immediately before and after both interventions (patients group) - Day 1
Personal experience with VR session
Time frame: Immediately before and after both interventions (patients group) - Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exercise training and Traditional exercise training in people with Frozen Shoulder, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annelies Maenhout, PhD (0032473806159, annelies.maenhout@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D upper limb kinematics (time frame: During VR session (both groups) - Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.