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Assessing the impact of music & mirror therapy in virtual reality on arm function after stroke.

Upper limb rehabilitation in chronic stroke via a novel music-supported mirror therapy virtual reality intervention pilot trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001204437
Enrollment
9
Registered
2025-10-31
Start date
2025-09-25
Completion date
2025-12-31
Last updated
2025-11-10

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

Conditions

None listed

Brief summary

This 8-week, home-based pilot trial will quantify the effectiveness, engagement, feasibility, and safety of REFLECT through the measurement of the following therapeutic outcomes: upper limb function (FMA-UE), cognitive function (MoCA), health-related quality of life (SIS), and anxiety and depression (HADS). These assessments will occur at 5 timepoints, 1 month pre-intervention, directly pre-intervention, directly post-intervention, 1-month post-intervention, and 3-months post-intervention. Participants will be requested to use REFLECT for 40 hours total, in 2x 30 min, 3x 20 min, or 4x 15 min increments for 1 hour/day, 5 days/week, for 8 weeks. THEORY: REFLECT has been developed based on research evidence that mirror therapy, music, and virtual reality exercise can provide improvements in upper limb function; visuospatial neglect symptoms; mood; cognitive functions such as memory, literacy, and numeracy skills; and physiological measures such as heart rate and blood pressure. RATIONALE: Combining a series of known therapeutic techniques (VR exercise, Mirror Therapy, and Music Therapy) is expected to produce positive interaction effects for stroke survivors. OBJECTIVES: (1) to determine if delivering music-based mirror therapy in a virtual reality environment can improve upper limb function post-stroke in adults, as measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE). (2) to deliver a virtual reality-based upper limb stroke rehabilitation intervention that is engaging, affordable, and enjoyable. (3) for the intervention to include an opportunity for musical creation in a population that are typically unable to access conventional musical instruments due to disability.

Interventions

INTERVENTION NAME: REFLECT REFLECT is an acronym for: Rehabilitation with Engaging Feedback and Learning Enrichment through Combined Therapies. INTERVENTION DESCRIPTION: Music-supported mirror therapy delivered via a novel virtual reality (VR) application, co-designed with stroke survivors (n=13) and professionals (n=12). The content of REFLECT includes 10x guided mirror therapy + song pairs ranging from gross motor to fine motor exercises, plus the option to create music with 10x different son

INTERVENTION NAME: REFLECT REFLECT is an acronym for: Rehabilitation with Engaging Feedback and Learning Enrichment through Combined Therapies. INTERVENTION DESCRIPTION: Music-supported mirror therapy delivered via a novel virtual reality (VR) application, co-designed with stroke survivors (n=13) and professionals (n=12). The content of REFLECT includes 10x guided mirror therapy + song pairs ranging from gross motor to fine motor exercises, plus the option to create music with 10x different songs; the upper limb rehab exercises built into REFLECT include: Shoulder Flexion Up/Down; Reach Forwards/Return; Clapping In/Out; Wrist Pronation/Supination; Elbow Flexion/Extension; Wrist Flexion/Extension; Fist Clench/Unclench; Cylindrical Grip; Finger Counting; Thumb Opposition MATERIALS: 1x VR headset (with REFLECT pre-loaded) + 1x Axivity AX6 activity monitor. Participants will also be provided with an information sheet, user guide, and weekly journal. The information sheet, user guide, and weekly journal have been designed specifically for this study and are intended to be used as a resource and for for participant documentation throughout the pilot trial. Participants will be asked to continuously wear an activity monitor on the wrist of their affected side for 12 weeks (during the 8 week intervention + 2 weeks before/after). The wrist-worn activity monitor should be worn at all times (including sleeping and bathing), however, the participant may temporarily remove it at their discretion if continual use become uncomfortable/unbearable. This will provide an indicator of general upper limb use over time. REFLECT involves the translation of upper limb rehabilitation exercises, and functional activities of daily living into music-based mirror therapy movements that will be performed in VR. SCHEDULE: Prior to commencing use with REFLECT, participants will complete a 2-hour onboarding & training session in their home, led by the Principal Investigator. The onboarding session will include a full demonstration of REFLECT, connection to the home Wi-Fi, and a Q&A with the participant, and any family members/ carers/ support workers present. In line with literature guidelines, the participants will be asked to use REFLECT for 1 hour/day 2x 30 min, 3x 20 min, or 4x 15 min sessions totalling 1 hour/day, 5 days/week, for 8 weeks (40 hours total). However, this may not be possible for all participants. There will not be any consequence the participants need to take days off or shorten the use due to family/ work/ volunteering/ person commitments/ additional therapy/ fatigue. Participants will not be asked to increase or decrease their usage of REFLECT during the pilot trial, however, if no usage is recorded for over 1 week, the research term may enquire whether the user is encountering any technical difficulties. Adherence will be monitored via continual uploads of (non-identifying) usage & app interaction data to a secure server, accessible only to the Principal Investigator. A mid-point check-in visit is built into the pilot trial to download the data from the activity monitor and recharge it's batteries, which will also provide an opportunity of in-person technical support. LOCATION: Participant's home. TAILORING: All participants will receive the same version REFLECT, however, they will have the choice of how they use it (e.g. which songs are selected and movements are performed). Additionally, users will be encouraged to calibrate the system to their range of motion.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adults (18+) • Chronic stroke (6+ months post-stroke) • Hemiparetic upper limb impairment (FMA-UE < 60) • Ability to read and understand spoken English

Exclusion criteria

• Stroke occurred during childhood (< 18) • Non-stroke-related upper limb hemiparesis • No function in both arms or hands • Severe cognitive impairment (MoCA < 10) • High susceptibility to motion sickness (unable to tolerate VR) • Unable to experience VR due to visual impairments • Unable to experience music due to hearing impairments • Inability to comprehend English (read/consent) • History of seizures, loss of awareness, or other symptoms linked to an epileptic condition

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026