Virtual Reality's Impact on Upper Limb Function in Post-stroke Patients

NCT06881680 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-202411-013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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)".

Conditions

Stroke

Keywords

stroke; rehabilitation; virtual reality (VR); body representation; upper limb dysfunction

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)

  The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) covers all aspects of upper limb function, such as movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand, with a total of 33 assessment items. Patients were assessed according to a specific scale with a total score of 66, with higher scores indicating better recovery of upper limb function.

  There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end

Secondary Outcomes (8)

• Sense of ownership questionnaire

  There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end

• Proprioceptive drift scale

  There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end

• Action Research Arm Test

  There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end

• National institutes of health stroke scale

  There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end

• Mini-mental state examination

  There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end

Study Arms (3)

Immersive and Interactive VR group

EXPERIMENTAL

The design of this group combines rich immersive VR scenes and specific interactive tasks. Specifically, there were two VR scenes: (1) Natural scenery: The subjects were on a quiet forest path, surrounded by tall trees, birdsong, and the sound of gurgling water. In this scene, the program sets the virtual hand on the hemiplegic side to perform the task of grasping the sphericalfruit on the tree. Each time the fruit is grasped for 3 seconds, and then released for 3 seconds; (2) City park: The subject was located in a city park surrounded by the sounds of children playing and the background sounds of the natural environment. In this scenario, the program sets the virtual hand on the hemiplegic side to carry out the task of grasping a ping-pong ball in the park, holding it for 3 seconds at a time and then releasing it for 3 seconds. To improve the actual participation, a real object the same as the virtual object will be provided in the real world, and subjects will be instructed to use

Device: virtual reality (VR) head mounted display

Interactive VR group

ACTIVE COMPARATOR

The VR scene in this group focuses on basic motor interaction, and the virtual background is the same as the control group. The program will set the virtual hand on the hemiplegic side to complete specific interaction tasks, such as grasping the virtual ball, holding the virtual ball for 3 seconds each time, and then releasing it for 3 seconds. At the same time, a real sphere of the same size and color as the virtual ball will be provided in the real world, and the subject will be instructed to perform the same movement simultaneously as much as possible with the real hand on the hemiplegic side.

Device: virtual reality (VR) head mounted display

Control group

ACTIVE COMPARATOR

subjects were asked to wear an HTC Vive HMD and enter a simple virtual testing environment. The environment has no complex narrative or visual effects, nor does it emphasize specific interaction tasks. It only includes a realistic virtual hand model of the hemiplegic side and the same virtual background as the real experiment, both are presented from a first-person perspective. The program will set the virtual hand on the hemiplegic side to perform simple and repetitive grasping movements. Each fist hold lasts for 3 seconds and then releases for 3 seconds. At the same time, the subject will be instructed to perform the same movement simultaneously with the real hand on the hemiplegic side as much as possible.

Device: virtual reality (VR) head mounted display

Interventions

virtual reality (VR) head mounted display DEVICE

This group of subjects received immersive and interactive VR training, which combined rich immersive VR scenes with specific interactive tasks, including two VR scenes. Task selection was based on the subjects' upper limb functional performance, and experienced therapists provided guidance and monitoring, and adjusted the tasks when necessary.

Control group; Immersive and Interactive VR group; Interactive VR group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital

Jinan, Shangdong, China

Location

Related Publications (5)

• 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.

  PMID: 29156493 BACKGROUND

• 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.

  PMID: 39133660 BACKGROUND

• 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.

  PMID: 33826456 BACKGROUND

• 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.

  PMID: 37745019 BACKGROUND

• 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.

  PMID: 39934877 BACKGROUND

Related Links

• Effectiveness of Immersive Virtual Reality-Based Hand Rehabilitation Games for Improving Hand Motor Functions in Subacute Stroke Patients
• 360° immersive virtual reality-based mirror therapy for upper extremity function and satisfaction among stroke patients: a randomized controlled trial
• Effects of virtual reality-based motor control training on inflammation, oxidative stress, neuroplasticity and upper limb motor function in patients with chronic stroke: a randomized controlled trial

MeSH Terms

Conditions

Stroke

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Qianxi Xu

CONTACT

86-18563719027; xqianxi0101@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-02

Locations

CN (1)