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

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06881680
• Lead Sponsor: Qilu Hospital of Shandong University

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)".

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2027-05-31
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	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.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	The Action Research Arm Test (ARAT) consists of 19 evaluated tasks bifurcated into four subscales: grasping, gripping, pinching, and gross motor skills. The total score ranges from 0 and 57, with higher scores representing better function.
Surface electromyography	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	Electrodes were placed on the key muscle groups of the hemiplegic upper limb according to the Surface EMG for the Non-Invasive Assessment of Muscles guidelines. In addition to the biceps and triceps brachii muscles of the upper arm, eight electrodes were placed evenly at the maximal circumference of the forearm cross-section, in which the electrodes were distributed on the centerlines of the anterior, ulnar, posterior, and radial sides of the forearm. Before placing the electrodes, the skin surface was cleaned with alcohol and the sampling rate was set to 1000 Hz. subjects were asked to perform 11 simple normative upper limb functional tasks, which were designed by Li et al. based on the FMA-UE scale . The sEMG signals were recorded during the performance of the tasks, which were repeated three times with at least 30 seconds of rest between each trial.
Sense of ownership questionnaire	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	The sense of ownership (SOO) questionnair investigates a number of aspects including sense of body ownership, sense of position in the real or virtual hand, haptic experience, body similarity, and body transformation. Scores are allocated on a 7-point Likert scale, from "Strongly disagree (-3 points)" to "Strongly agree (3 points)", depending on how much the patient agrees with each statement. The mean score of all questions is calculated as the final SOO questionnaire score, and the higher the score, the stronger the SOO.
Proprioceptive drift scale	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	We asked patients to report where they thought their affected hand was by pointing with their other hand or describing it verbally and compared this with the position of the affected hand they initially felt to calculate the offset distance, thereby measuring the degree of proprioceptive error.
Mini-mental state examination	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	The Mini-Mental State Examination scale(MMSE) is mainly used to quickly assess cognitive areas such as memory, orientation, attention, calculation, language ability, and visual-spatial ability. The scale contains 30 questions with a total score range of 0-30 points. The higher the total score, the better the cognitive function. The normal threshold is divided according to the educational level (for example, those with junior high school education or above need to score ≥24 points).
Electroencephalography	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	The subjects were seated comfortably and asked to close their eyes, wake up, relax, and be quiet for 5 minutes. The recording electrodes were placed on the scalp according to the international 10/20 system, with the Cz electrode of the head as the reference. The impedance of each channel was ensured to be below 5k Ω and the sampling frequency was 1k Hz. EEG will be used to assess changes in brain activity by analyzing the power distribution across different frequency bands (delta, theta, alpha, beta), event-related potentials (ERPs) in response to motor tasks or stimuli, and the coherence between brain regions to evaluate motor network synchronization.
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	The scale covers the level of consciousness, extraocular movements, visual fields, facial muscle function, limb strength, sensory function, coordination (ataxia), speech (aphasia), language (dysarthria), and lateralized inattention (neglect). The scoring spectrum extends from 0 to 42 points, with the higher the score, the more severe neurologic damage.
functional Magnetic Resonance Imaging	There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end	The subjects were asked to remain still and provided with earplugs to alleviate discomfort from scanning noise. Functional images were acquired using an echo-planar imaging (EPI_BOLD) sequence with scanning parameters as follows: repetition time = 3000 ms, echo time = 30 ms, flip angle = 90 degrees, field of view = 220 × 220 mm, matrix size = 64 × 64, layer thickness = 3 mm layer position = 43, and a total of 240 time points being captured over a scanning period of 12 minutes.

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shangdong, China