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临床试验/NCT07709065
NCT07709065已完成不适用

Acute Effect of Immersive VR Technology on Postural Control and Reaction Time in Young Adults: a Randomized Controlled Trial

University of Rzeszow1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2026年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
Composite Score (CS) (%)

研究概览

简要总结

This study investigates the acute effects of short-term immersive virtual reality (VR) exposure on sensory organization and reaction time in young adults aged 18-25 years. It is designed as a randomized controlled trial.

Participants are eligible if they provide written informed consent, complete all study questionnaires, are aged 18-25 years, are able to maintain an upright standing posture, have non-professional athletic status, have no neurological or psychiatric disorders, use a phone or computer for at least 1 hour per day, and do not take medication affecting the nervous system. Exclusion criteria include age outside the 18-25 range, pregnancy, disability, metal implants, epilepsy, inability to provide consent, frequent migraines, balance disorders, recent surgery or injury (within 6 months), uncorrected visual impairment, skin conditions or allergies preventing device use, acute illness on the day of testing, shift work causing circadian rhythm disruption, prior regular VR use, claustrophobia or anxiety related to enclosed spaces or simulated movement, and intensive physical activity within 24 hours before testing.

Eligible participants are randomly allocated in a 1:1 ratio using sequentially numbered, sealed, opaque envelopes to either a VR intervention group or a control group.

All participants are assessed at baseline and after a 20-minute interval. In the VR group, post-assessment is performed immediately after VR exposure, while in the control group it follows a matched resting period. All measurements are conducted by a single trained examiner at a similar time of day using a standardized protocol. Anthropometric measurements (height and body mass) are obtained barefoot using a medical scale (Charder MS4971, Taiwan), and body mass index (BMI) is calculated.

Postural control and reaction time are assessed using computerized dynamic posturography with the NeuroCom Balance Manager system. Two standardized protocols are used: the Sensory Organization Test (SOT) and the Limits of Stability (LOS). The SOT evaluates the integration of somatosensory, visual, and vestibular inputs for postural control across six sensory conditions involving variations in platform and visual stability. The LOS assesses voluntary control of the center of gravity toward visual targets without loss of balance, providing measures of movement accuracy and reaction time from movement initiation to target acquisition.

The primary outcome is the composite SOT score. Secondary outcomes include SOM, VIS, VEST, and PREF parameters derived from the SOT, as well as reaction time measured in the LOS protocol.

The experimental group undergoes a 20-minute VR intervention using the HTC VIVE Cosmos. The intervention consists of a gamified motor coordination task ("Adventure Climb") requiring continuous postural adjustments, rapid visuomotor responses, and whole-body movement coordination in a standing position. The task is designed to stimulate visual-motor integration and dynamic balance control. The control group remains at rest for the same duration and does not receive any active intervention, allowing isolation of the effects of VR exposure. Due to the nature of the intervention, blinding of participants, assessors, and intervention providers is not feasible.

After the intervention or rest period, all participants repeat the SOT and LOS assessments under identical conditions to evaluate the acute effects of VR exposure on postural control and reaction time.

详细描述

This study evaluates the acute effects of short-term immersive virtual reality (VR) exposure on sensory organization and reaction time in young adults aged 18-25 years. It is designed as a randomized controlled trial.

Participants are eligible if they provide written informed consent and complete all study questionnaires, are aged between 18 and 25 years, are able to maintain an upright standing posture, have non-professional athletic status, have no diagnosed neurological or psychiatric disorders, use a phone or computer for at least 1 hour per day, and do not use medication affecting the nervous system. Exclusion criteria include age under 18 or over 25 years, pregnancy, disability, metal implants, epilepsy, inability to provide informed consent, frequent migraines, balance disorders, surgery or injury within the previous 6 months, uncorrected visual impairment, skin conditions or allergies preventing device use, acute illness on the day of testing, shift work causing circadian rhythm disruption, prior regular use of VR technology, claustrophobia or anxiety related to enclosed spaces or simulated movement, and intensive physical activity within 24 hours prior to testing.

Eligible participants are randomly allocated in a 1:1 ratio using sequentially numbered, sealed, opaque envelopes to either a VR intervention group or a control group.

All participants are assessed at baseline and again after a 20-minute interval. In the VR group, the post-assessment is conducted immediately after VR exposure, whereas in the control group it follows a matched resting period. All measurements are performed by a single trained examiner at a similar time of day using a standardized protocol. Anthropometric data, including height and body mass, are collected barefoot using a medical scale (Charder MS4971, Taiwan), and body mass index (BMI) is calculated.

Postural control and reaction time are evaluated using computerized dynamic posturography with the NeuroCom Balance Manager system, applying two standardized protocols: the Sensory Organization Test (SOT) and the Limits of Stability (LOS). The SOT assesses integration of somatosensory, visual, and vestibular inputs for postural control through six conditions (fixed or sway-referenced platform and vision), each repeated three times, conducted according to manufacturer guidelines with participants standing in a safety harness and standardized foot positioning aligned to the platform's axis of rotation. The LOS protocol evaluates voluntary control of the center of gravity toward visual targets without losing balance, providing measures of movement accuracy and reaction time from initiation of weight shift to target acquisition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent and complete questionnaire completion;
  • age between 18 and 25 years;
  • ability to maintain upright standing posture;
  • non-professional athletic status;
  • no neurological or psychiatric disorders;
  • regular use of a phone or computer for at least 1 hour per day;
  • no medication affecting the nervous system.

排除标准

  • age <18 or >25 years;
  • pregnancy;
  • disability;
  • metal implants;
  • epilepsy;
  • lack of informed consent;
  • frequent migraines;
  • balance disorders;
  • surgery or injury within the previous 6 months;
  • uncorrected visual impairment;
  • skin conditions or allergies preventing device use;
  • acute illness on the day of testing;
  • shift work causing circadian rhythm disruption;
  • prior regular use of VR technology;
  • claustrophobia or anxiety related to enclosed spaces or simulated movement; and
  • intensive physical activity within 24 hours prior to testing.

结局指标

主要结局

Composite Score (CS) (%)

时间窗: up to 10 weeks

Composite score (CS) is assessed using the NeuroCom Balance Manager system during the Sensory Organization Test (SOT). The score represents overall postural stability across all SOT conditions. Higher scores indicate better postural stability.

次要结局

  • Somatosensory Index (SOM) (%)(up to 10 weeks)
  • Visual Index (VIS) (%)(up to 10 weeks)
  • Vestibular Index (VEST) (%)(up to 10 weeks)
  • Visual Preference Index (PREF) (%)(up to 10 weeks)
  • Reaction Time (RT) (s)(up to 10 weeks)

研究者

发起方
University of Rzeszow
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maciej Kochman

Principal Investigator

University of Rzeszow

研究点 (1)

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