NCT07392762

Brief Summary

People with long-term (chronic) shoulder disorders caused by injuries, overuse or conditions (such as arthritis) often need physiotherapy. This usually includes exercise therapy to help reduce pain, rebuild strength and make every day activities easier. However, it can be hard to stick to an exercise programme. People may stop due to pain, fear of making the symptoms worse or simply loosing motivation. Virtual Reality (VR) is a technology that may help people say engaged with their exercise programmes by making exercises more enjoyable and interactive. When using a headset (similar to goggles), people can see and interact with a 3D virtual world. Their movement, especially their hands and arms, are shown as an 'avatar' (a virtual character) in this virtual world. Exercise can feel more like playing a game or engaging with tasks/challenges, rather than performing repetitive movements. This shift might help reduce focus on pain and increase motivation. VR also provides real-time feedback, helping people track their progress and adjust their movements instantly. This might lead to more accurate and consistent exercise performance and better recovery outcomes. Before we can test whether VR exercise programmes are effective for people with chronic shoulder disorders, we firstly need to understand whether it is practical and acceptable for patients to use. This 'feasibility' study will therefore involve 20 patients with chronic shoulder disorders referred for physiotherapy at the Royal National Orthopaedic Hospital (RNOH) in Stanmore, United Kingdom. Participants will take part in three VR exercise sessions at the RNOH over a three-week period. Levels of pain, quality of life and sleep quality etc. will be measured before and after three weeks. Interviews will also be held up to two weeks after the final session to explore people's experiences and thoughts towards the VR exercise programme. The results will help us decide if a larger study should go ahead.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 15, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 6, 2026

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

January 15, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

Virtual RealityVRMusculoskeletal RehabilitationMusculoskeletal Shoulder PainChronic Shoulder PainShoulder pain disorders

Outcome Measures

Primary Outcomes (2)

  • Consent rate

    The consent rate will be used as a measure of recruitment and will be defined as the number of participants who provide informed consent divided by the total number of patients screened for eligibility, ie: number of people who consented/number of people approached) x 100.

    During enrolment period

  • Dropout rate

    The dropout rate will be defined as the percentage of participants who started the study, but did not complete all three treatment visits.

    From first treatment visit though completion of treatment (average of 3 weeks)

Secondary Outcomes (8)

  • Pain Intensity - Numeric Pain Rating Scale (NPRS)

    * Baseline (Pre-intervention), * Immediately before and after each treatment session (up to 3 visits), * One follow-up 1 visit (within 48 hours of the last treatment session, average of 3 weeks)

  • Shoulder Range of Movement

    Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).

  • Disability - Shoulder Pain and Disability Index (SPADI)

    Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).

  • Quality of Life - EuroQol- 5 Dimension (EQ-5D-3L)

    Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).

  • Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)

    Baseline (pre-intervention) and at follow-up 1(within in 48 hours of final treatment session, average of 3 weeks).

  • +3 more secondary outcomes

Study Arms (1)

Virtual Reality Exercise Programme

EXPERIMENTAL

Consenting participants will attend three VR exercise sessions delivered by an upper limb physiotherapist at the Royal National Orthopaedic Hospital (RNOH), using the SyncVR FIT platform. The SyncVR FIT platform is designed to support unilateral or bilateral upper limb movement through a series of interactive games, tasks, and challenges delivered via a VR headset. Participants will use handheld controllers to engage with these activities, enabling the system to track upper limb motion. While wearing the headset, participants will see a virtual representation of their upper limbs-specifically their hands-within the VR environment. These virtual hands mirror the participants' real-time movements, enhancing the sense of immersion and embodiment. A tablet device will be used by the intervention provider to monitor the session.

Device: Virtual Reality

Interventions

Participants will engage with a 30 minute shoulder exercise programme using the SyncVR platform. There will be three intervention sessions in total and they will be spaced out once per week for a period of three weeks.

Virtual Reality Exercise Programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \>18 years with diagnosed unilateral/ bilateral shoulder pain with/ without co-existing symptoms of instability and or stiffness (persisting \> three months) generated from a Musculoskeletal origin
  • Patients who have been referred for conservative management
  • New or follow-up patients
  • Sufficient English to understand written materials/verbal instruction/or accompanied by family/friends able to translate
  • Patients who provide informed, written consent to enter the study

You may not qualify if:

  • Unable to provide informed consent
  • On a waiting list for surgery and/or injections
  • Referred for post-operative physiotherapy
  • Shoulder pain not originating from an MSK aetiology (such as hemiplegia or peripheral nerve injury)
  • Active history of seizures
  • Other relevant medical conditions deemed inappropriate for patients to participate e.g. visual impairment, unstable psychiatric illnesses.
  • Shoulder pain associated with bone metastasis
  • Currently taking part in any other upper limb research study
  • Patients who do not adequately understand verbal explanations or written information given in English (or are not accompanied by an interpreter/family member).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Orthopaedic Hospital

Middlesex, London, HA74LP, United Kingdom

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anju Jaggi, MSc

    Royal National Orthopaedic Hospital

    STUDY DIRECTOR

Central Study Contacts

Rokhsaneh m Tehrany, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The SyncVR FIT platform is designed to support unilateral or bilateral upper limb movement through a series of interactive games, tasks, and challenges delivered via a VR headset (PICO 4). Participants will use handheld controllers to engage with these activities, enabling the system to track upper limb motion. While wearing the headset, participants will see a virtual representation of their upper limbs-specifically their hands-within the VR environment. These virtual hands mirror the participants' real-time movements, enhancing the enhancing the sense of immersion and embodiment. A tablet device will be used by the intervention provider to monitor the session.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

February 6, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 6, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations