Clinical trial NCT06881680: Virtual Reality's Impact on Upper Limb Function in Post-stroke Patients
Official title: Effects of Virtual Reality Features on Upper Limb Motor Function in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
virtual reality (VR)
body representation
upper limb dysfunction
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke rank second among the top causes of death, affecting millions of people in the worldwide. Approximately 70-80% survivors of stroke could experience various levels of upper limb motor impairments, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. As bottleneck effect in traditional rehabilitation techniques become apparent, a number of emerging technologies are being used in rehabilitation treatment in an attempt to break down this barrier.Studies have shown that virtual reality (VR) training can effectively promote the remodeling of the central nervous system and has become an important research direction for motor function rehabilitation.However, most current studies still focus on evaluating the overall intervention effect of VR, with little examination of its intrinsic properties and a lack of exploration of the sense of ownership (SOO) and agency (SOA).

Hence, this study conducted different VR interventions on stroke patients to evaluate the effects of the intrinsic properties of VR and the body illusion it produces on the rehabilitation of their upper limb motor function.

This study is a single-blind randomized controlled trial. A total of 120 participants will be enrolled and divided into a control group, an interactive VR group, and an immersive and interactive VR group. All groups will be tested on the virtual hand illusion before the intervention. The intervention will last for a fortnight, four times a week for one hour each time. Assessment will be conducted before the intervention, at the end of the intervention, and at week 6 for follow-up. The primary outcome measure is the "Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)". The secondary outcome measures are "SOO questionnaire", "proprioceptive drift scale", "action research arm test (ARAT)", "NIH stroke scale (NIHSS)", "mini mental state examination (MMSE)", "electromyography (EMG)", "electroencephalography (EEG)" and "functional Magnetic Resonance Imaging (fMRI)".


Eligibility criteria: Inclusion Criteria:

* First episode of stroke, hemorrhagic or ischemic, confirmed by computed tomography or magnetic resonance imaging of the brain;
* Age 40-80 years, either male or female;
* 3-12 months since stroke occurrence;
* Mild-to-moderate or moderate-to-severe upper extremity impairment, with a FMA-UE score between 16 and 53;
* Basic ability to communicate and comprehend the research instructions, with a score of 21 and above on the MMSE scale;
* Agreement to participate in the study, with an informed consent form duly signed by the patient or a family member.

Exclusion Criteria:

* The presence of ferromagnetic metals implanted in the body;
* Visual or hearing deficits;
* Unstable medical conditions;
* History of receiving similar VR training in the past;
* A history of myasthenia gravis, multiple sclerosis, muscular dystrophy, or other diseases that may cause upper limb movement disorders.

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Secondary outcomes:
measure: Sense of ownership questionnaire
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: Proprioceptive drift scale
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: Action Research Arm Test
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: National institutes of health stroke scale
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: Mini-mental state examination
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: Surface electromyography
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: Electroencephalography
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
measure: functional Magnetic Resonance Imaging
timeFrame: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shangdong
Study officials:
References:
citation: Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
citation: Ventura S, Tessari A, Castaldini S, Magni E, Turolla A, Banos R, Lullini G. Effectiveness of a Virtual Reality rehabilitation in stroke patients with sensory-motor and proprioception upper limb deficit: A study protocol. PLoS One. 2024 Aug 12;19(8):e0307408. doi: 10.1371/journal.pone.0307408. eCollection 2024.
citation: Tambone R, Giachero A, Calati M, Molo MT, Burin D, Pyasik M, Cabria F, Pia L. Using Body Ownership to Modulate the Motor System in Stroke Patients. Psychol Sci. 2021 May;32(5):655-667. doi: 10.1177/0956797620975774. Epub 2021 Apr 7.
citation: Bargeri S, Scalea S, Agosta F, Banfi G, Corbetta D, Filippi M, Sarasso E, Turolla A, Castellini G, Gianola S. Effectiveness and safety of virtual reality rehabilitation after stroke: an overview of systematic reviews. EClinicalMedicine. 2023 Sep 14;64:102220. doi: 10.1016/j.eclinm.2023.102220. eCollection 2023 Oct.
citation: Goizueta S, Navarro MD, Calvo G, Campos G, Colomer C, Noe E, Llorens R. Touchscreen-based assessment of upper limb kinematics after stroke: Reliability, validity and sensitivity to motor impairment. J Neuroeng Rehabil. 2025 Feb 11;22(1):27. doi: 10.1186/s12984-025-01563-6.