Shoulder InstabilityNCT06963983
Virtual Reality Rehabilitation for Shoulder Pathologies
A study testing Rehabilitation using virtual reality in people with Shoulder Instability and Frozen Shoulder, run by La Tour Hospital at 1 site in Switzerland.
Trial summary
Most rehabilitation protocols require patients to train the affected limbs with high regularity, following repetitive cycles of exercises, in order to recover mobility and strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Instability, Frozen Shoulder, Rotator Cuff Tears
- What is being tested?
- Rehabilitation using virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Oct 2024to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients able to understand the content of the patient information / consent form and give consent to take part in the research project
- Glenohumeral instability surgical treated with traumatic initial instability in a < 20 years old athlete, recurrent instability with one or more of the following criteria: a failure of conservative treatment, locked dislocation, failed prior surgery, high risk for further recurrence (i.e. collision or competitive athletes), Critical glenoid bone-loss (>15-20%), bipolar bone-loss resulting in "off-track" lesion
- Partial or complete rotator cuff repair with an indication to postoperative rehabilitation depending on surgeon recommendation
- Idiopathic, primary, or secondary frozen shoulder
Who cannot join
- Patients with a language barrier hindering questionnaires completion
- Patients unlikely to attend clinical follow-up (e.g. when living abroad)
- Legal incompetence
- Enrolment of the investigators, his/her family members, employees and other dependent persons
- Non-motivated patients
- Active infection
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- Exclusion criteria related to glenohumeral instability: uncontrolled epilepsy, spontaneous unidirectional instability in a hyperlax patient, multidirectional instability, elher-Danlos syndrome
- Exclusion criteria related to rotator cuff tears: Additional procedure(s) (muscle transfer, patch,…)
- Exclusion criteria related to VR use: Patients with a predisposition to motion sickness, Patients suffering from epilepsy or having any serious mental illness (schyzophrenia, neurological problems, etc.), Patients with visual impairment , Patients will intellectual disability that prevent them to understand how to use the VR rehabilitation system, Patients with bilateral upper limb injuries, as one side is needed as healthy reference
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
La Tour hospital
Meyrin, Canton of Geneva, 1217
Hugo Bothorel, MEng, +41 22 719 78 33, hugo.bothorel@latour.ch
About this study
Official title: Personalized Rehabilitation System Using Gamification With Virtual Reality Technology: A Feasibility Study
Most rehabilitation protocols require patients to train the affected limbs with high regularity, following repetitive cycles of exercises, in order to recover mobility and strength. Nonetheless, the repetitive nature of these exercises can demotivate patients leading to less intense and committed training, if not ending with a lack of compliance toward the prescribed exercises, ultimately leading to a suboptimal recovery. For this reason, several research groups are investigating solutions to help patients in this process, using robotic support or protocols assisted by virtual reality (VR).
Most of these studies have shown benefits, notably in the field of post-stroke rehabilitation, however numerous types of physical therapies have not been investigated yet. Therefore, the main goal of this study will be to explore if the combination of modern motion-tracking and VR can provide significant functional outcomes for the treatment of the most common upper limb pathologies. The investigators created a set of exergames designed to lead the patients through a gamified version of part of physiotherapy (PT). This modified therapy is expected to offer several benefits to the treatment with respect to a purely conventional therapy: (i) improved patient's motivation and commitment to the exercises; (ii) constant evaluation of the patient's performance, thanks to the use of motion tracking; (iii) session-by-session tuning of exercises difficulty; (iv) clear progress traceability; (v) real-time alerts in case of problematic or compensatory movements; (vi) measurement and evaluation of new metrics of movements quality that were not possible in conventional therapy setups.
To evaluate the feasibility of this project, the investigators would like to test the VR system on a short series of patients during four sessions.
- Conditions
- Shoulder Instability, Frozen Shoulder, Rotator Cuff Tears
- Being tested
- Rehabilitation using virtual reality
- Medical subject headings
- Bursitis, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation using virtual realityDevice
During the four physiotherapy (PT) sessions (60 min for each session), a set of exercises from the conventional PT is replaced by multiple short sessions of 30 minutes each, where the patient will be equipped by a set of motion trackers mounted on a belt and on a set of straps to be worn around both arms and both forearms. The patient will also hold a controller in each hand and wear a commercial VR headset on his head. Then, thanks to the headset, the patient will be able to experience a set of VR environments, where he or she will be guided through a set of exergames. His/her movements in the real world will be used to move his/her avatar's body in the virtual world, and the exergames will be designed to push him/her to perform the motions required by the therapy in order to go through the games. Various strategies, including a virtual coach will also appear to prevent the patient from doing potentially hazardous movements.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Pathology Group | Experimental | Patients suffering from either shoulder instability, frozen shoulder or rotator cuff tears Receives: Device: Rehabilitation using virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulator Sickness Questionnaire
From 1 (best) to 7 (worst)
Measured: Day 1
Secondary outcomes (3)
A reduced version of the Post-experimental Intrinsic Motivation Inventory
From 1 (worst) to 7 (best)
Measured: Day 1
A reduced version of the Avatar Embodiment Questionnaire
From 1 (worst) to 7 (best)
Measured: Day 1
Patient satisfaction
4-Point Likert Scale (Not satisfied at all, Not satisfied, Satisfied, Very satisfied)
Measured: 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 May 2025
- Study start28 Oct 2024
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandre Lädermann, La Tour Hospital
- Investigators
- Alexandre Lädermann, MD, Principal investigator, La Tour hospital, Meyrin (1217) Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963983
- Sponsor's protocol ID
- 2022-00166
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Rehabilitation System Using Gamification With Virtual Reality Technology: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06963983
- Acronym / sponsor ID
- 2022-00166
- Conditions
- Shoulder Instability, Frozen Shoulder, Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 9 May 2025 (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.
Most rehabilitation protocols require patients to train the affected limbs with high regularity, following repetitive cycles of exercises, in order to recover mobility and strength. Nonetheless, the repetitive nature of these exercises can demotivate patients leading to less intense and committed training, if not ending with a lack of compliance toward the prescribed exercises, ultimately leading to a suboptimal recovery. For this reason, several research groups are investigating solutions to help patients in this process, using robotic support or protocols assisted by virtual reality (VR).
Most of these studies have shown benefits, notably in the field of post-stroke rehabilitation, however numerous types of physical therapies have not been investigated yet. Therefore, the main goal of this study will be to explore if the combination of modern motion-tracking and VR can provide significant functional outcomes for the treatment of the most common upper limb pathologies. The investigators created a set of exergames designed to lead the patients through a gamified version of part of physiotherapy (PT). This modified therapy is expected to offer several benefits to the treatment with respect to a purely conventional therapy: (i) improved patient's motivation and commitment to the exercises; (ii) constant evaluation of the patient's performance, thanks to the use of motion tracking; (iii) session-by-session tuning of exercises difficulty; (iv) clear progress traceability; (v) real-time alerts in case of problematic or compensatory movements; (vi) measurement and evaluation of new metrics of movements quality that were not possible in conventional therapy setups.
To evaluate the feasibility of this project, the investigators would like to test the VR system on a short series of patients during four sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Pathology Group | Experimental | Device: Rehabilitation using virtual realityPatients suffering from either shoulder instability, frozen shoulder or rotator cuff tears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients able to understand the content of the patient information / consent form and give consent to take part in the research project
- Glenohumeral instability surgical treated with traumatic initial instability in a < 20 years old athlete, recurrent instability with one or more of the following criteria: a failure of conservative treatment, locked dislocation, failed prior surgery, high risk for further recurrence (i.e. collision or competitive athletes), Critical glenoid bone-loss (>15-20%), bipolar bone-loss resulting in "off-track" lesion
- Partial or complete rotator cuff repair with an indication to postoperative rehabilitation depending on surgeon recommendation
- Idiopathic, primary, or secondary frozen shoulder
Key exclusion criteria (9 listed)
- Patients with a language barrier hindering questionnaires completion
- Patients unlikely to attend clinical follow-up (e.g. when living abroad)
- Legal incompetence
- Enrolment of the investigators, his/her family members, employees and other dependent persons
- Non-motivated patients
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 |
|---|---|---|
| Rehabilitation using virtual realityDuring the four physiotherapy (PT) sessions (60 min for each session), a set of exercises from the conventional PT is replaced by multiple short sessions of 30 minutes each, where the patient will be equipped by a set of motion trackers mounted on a belt and on a set of straps to be worn around both arms and both forearms. The patient will also hold a controller in each hand and wear a commercial VR headset on his head. Then, thanks to the headset, the patient will be able to experience a set of VR environments, where he or she will be guided through a set of exergames. His/her movements in the real world will be used to move his/her avatar's body in the virtual world, and the exergames will be designed to push him/her to perform the motions required by the therapy in order to go through the games. Various strategies, including a virtual coach will also appear to prevent the patient from doing potentially hazardous movements. | Device | Shoulder Pathology Group |
Primary outcome
Simulator Sickness Questionnaire
Time frame: Day 1
From 1 (best) to 7 (worst)
3 secondary outcomes
A reduced version of the Post-experimental Intrinsic Motivation Inventory
Time frame: Day 1
A reduced version of the Avatar Embodiment Questionnaire
Time frame: Day 1
Patient satisfaction
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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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.
Alexandre Lädermann, MD principal investigator
La Tour hospital, Meyrin (1217) Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation using virtual reality in people with Shoulder Instability and Frozen Shoulder, run by La Tour Hospital at 1 site in Switzerland.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 May 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Lädermann, MD (+41 22 719 75 55, alexandre.laedermann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulator Sickness Questionnaire (time frame: 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 May 2025.