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临床试验/NCT06754072
NCT06754072已完成不适用

Virtual Reality-Based Hand Rehabilitation for Post-Surgical Degenerative Cervical Myelopathy: A Pilot Study

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Jebsen-Taylor Hand Function Test

研究概览

简要总结

This clinical study aimed to evaluate the effectiveness of a virtual reality-based training intervention for improving hand dexterity and promoting neuroplasticity in individuals with Degenerative Cervical Myelopathy (DCM) after surgical decompression. Participants completed a 4-week training program using the Virtual Keyboard (VK) system, which facilitated repetitive, individualized finger movements in a virtual environment. Outcomes were measured pre- and post-training to quantify improvements in hand dexterity, quality of life, and cortical motor activity.

详细描述

Degenerative Cervical Myelopathy (DCM) is a leading cause of non-traumatic spinal cord injury, often resulting in impaired hand dexterity and diminished quality of life. Despite surgical decompression being the primary treatment, over 30% of individuals experience persistent functional disability due to a lack of targeted post-surgical rehabilitative interventions. This study sought to address this clinical gap by implementing and evaluating a virtual reality-based hand training intervention.

The central hypothesis was that an intensive, individualized training program using the Virtual Keyboard (VK) system would improve hand dexterity in individuals with DCM and that these functional gains would be supported by measurable changes in cortical motor activity.

Study Design

This single-arm interventional study recruited participants who had undergone cervical spine surgery within six months. A total of 25 participants were enrolled, each completing:

A 4-week training program consisting of 12 one-hour sessions using the VK system. The system provided engaging, interactive tasks designed to promote finger individuation and precise motor control through real-time visual and auditory feedback.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Degenerative Cervical Myelopathy.
  • Completed cervical spine surgery within 6 months.
  • Modified Japanese Orthopaedic Association (mJOA) upper limb motor score between 1-4.

排除标准

  • Pregnancy.
  • History of brain or upper extremity surgery within the past year.
  • Significant arm/hand pain limiting movement.
  • Complete paralysis of the hands (mJOA=0).

结局指标

主要结局

Jebsen-Taylor Hand Function Test

时间窗: Baseline, post-training and follow-up.

The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized test used to assess hand function during everyday activities. It consists of seven timed subtests, such as writing, card turning, and object manipulation. The outcome is recorded as the time taken to complete each task in seconds, where lower times indicate better hand function.

次要结局

  • Quantitative Electroencephalograms (qEEG)(Baseline, post-training and follow-up.)
  • Nine-Hole Peg Test (9HPT)(Baseline, post-training and follow-up.)
  • Box and Blocks Test (BBT)(Baseline, post-training and follow-up.)
  • QuickDASH(Baseline, post-training and follow-up.)
  • Three-point pinch strength(Baseline, post-training and follow-up.)
  • Touch sensitivity(Baseline, post-training (1 week after VK training), and 4-week follow-up ( 4 weeks after VK training).)
  • EuroQol 5-Dimension score(Baseline, post-training and follow-up.)
  • Short Form-36 Health Survey version 2(Baseline, post-training and follow-up.)
  • Modified Japanese Orthopedic Association scale(Baseline, post-training and follow-up.)
  • Myelopathy Disability Index(Baseline, post-training and follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aditya Vedantam

Associate Professor

Medical College of Wisconsin

研究点 (2)

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