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临床试验/NCT06417216
NCT06417216招募中不适用

Head-Cancelled Virtual Reality for Rehabilitation of Ocular Cranial Nerve Palsies

Kevin Houston3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
3
主要终点
Peak saccade amplitude

研究概览

简要总结

This study is investigating whether eye exercises for abducens palsy and internuclear ophthalmoplegia increase ocular range of motion in the paretic direction when performed in virtual reality under head-cancelled compared to head-active conditions.

详细描述

Participants with abducens palsy or internuclear ophthalmoplegia, two common types of ocular cranial nerve palsies, will perform 3 different tasks in virtual reality under head-cancelled and head-active conditions. Head active is the normal state, where gaze can be shifted by moving the head, the eyes, or a combination of the two. Head-cancelled refers to the condition where the scene moves with the head, rendering head movement ineffective to shift gaze. In this condition, the eyes must move in order to shift gaze. The hypothesis is that this requirement for eye movement will result in larger eye movements, which could be therapeutic. The tasks performed under the two conditions will include horizontal transposition of coins, repetitive horizontal saccades, and game play. The primary analysis will be a within subject's comparison of eye movement amplitude in head-cancelled (experimental) versus head-active (control) conditions. Additionally, as a control comparison for secondary analysis, a group with normal vision will also perform the tasks under both conditions.

研究设计

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

入排标准

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

入选标准

  • OCNP Group Inclusion Criteria:
  • Presence of OCNP in one eye with 50% range-of-motion limitation or worse
  • Able to provide informed consent and will be able to fluently read and understand spoken English

排除标准

  • Presence of bilateral OCNP
  • Range of motion better than 50%
  • Visual acuity worse than 20/100 in either eye
  • Greater than 4-line difference in visual acuity between the eyes,
  • Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset
  • Participants will be excluded if they are unable to participate if inclusion criteria are not met.
  • Normal Group Inclusion Criteria:
  • Absence of OCNP or other neurological or neuro-ophthalmic diseases
  • No strabismus
  • Have normal or near-normal vision with glasses or contact lenses.
  • Be able to provide informed consent and will be able to fluently read and understand spoken English
  • Normal Group Exclusion Criteria:
  • Visual acuity worse than 20/100 in either eye
  • Greater than 4-line difference in visual acuity between the eyes
  • Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset
  • Known inability to tolerate visual testing of at least 20 minutes continuously.

研究组 & 干预措施

Head Cancelled

Experimental

Study tasks performed in head-cancelled conditions

干预措施: Head-cancelled virtual reality (Behavioral)

Normal

No Intervention

Study tasks performed in normal conditions.

结局指标

主要结局

Peak saccade amplitude

时间窗: 5 minutes

Maximum amplitude of eye movement

次要结局

  • Mean head position(5 minutes)

研究者

发起方
Kevin Houston
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kevin Houston

Investigator

Brooks Rehabilitation

研究点 (3)

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