The Effectiveness of Leap Motion-Based Virtual Reality in the Rehabilitation of Flexor Tendon Injuries of the Hand
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Upper limb disability/function
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of a Leap Motion-based virtual reality rehabilitation program in patients who underwent surgical repair for flexor tendon injuries of the hand (zones II-V). A total of 66 participants, aged 18-65 years and at least 5 weeks postoperative, will be randomly assigned to two groups: the intervention group will receive routine hand rehabilitation plus Leap Motion-based virtual reality therapy for 20 minutes per day, 5 days per week, for 4 weeks; while the control group will continue routine hand rehabilitation only. Outcomes will include joint range of motion measured with a goniometer, pain intensity assessed with a Visual Analog Scale (VAS), grip strength measured with a Jamar dynamometer, and functional outcomes assessed using the QuickDASH questionnaire. The primary endpoint is the change in range of motion, grip strength, and QuickDASH score from baseline to post-treatment. Secondary endpoints include changes in upper extremity function and pain tolerance. All interventions will be delivered under therapist supervision. This study is expected to provide evidence on whether integrating Leap Motion-based virtual reality into conventional rehabilitation improves clinical outcomes after flexor tendon repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Flexor tendon injury of the hand (zones II-V)
- •Early surgical repair completed
- •At least 5 weeks postoperative
- •Eligible for routine hand rehabilitation program
排除标准
- •Communication problems
- •Cognitive impairment
- •Additional musculoskeletal, neurological, or rheumatological diseases affecting upper extremity function
- •Multiple trauma cases
研究组 & 干预措施
Experimental
Arm Title: Leap Motion + Routine Hand Rehabilitation
Description: Participants receive standard postoperative hand rehabilitation plus Leap Motion-based virtual reality training for 20 minutes/day, 5 days/week, for 4 weeks.
Intervention Type: Device (Leap Motion-based virtual reality therapy)
Other Intervention: Behavioral (Routine hand rehabilitation program)
干预措施: Leap Motion-based Virtual Reality Therapy (Device)
Active Comparator (Control)
Arm 2 - Active Comparator (Control)
Arm Title: Routine Hand Rehabilitation Only
Description: Participants receive only routine postoperative hand rehabilitation for 1 hour/day, 5 days/week, for 4 weeks.
Intervention Type: Behavioral (Routine hand rehabilitation program)
干预措施: Active Comparator - Routine Rehabilitation Only (Other)
结局指标
主要结局
Upper limb disability/function
时间窗: Baseline and 4 weeks post-treatment
Functional disability of the upper limb assessed with the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire. In the Q-DASH, a higher score indicates worse outcome, while a lower score indicates better outcome.
Joint range of motion (ROM)
时间窗: Baseline and 4 weeks post-treatment
Assessed with a manual goniometer. Comparison between baseline and after 4 weeks of treatment. A higher ROM indicates a better clinical condition.
Grip strength
时间窗: Baseline and 4 weeks post-treatment
Assessed using a Jamar hand dynamometer.
次要结局
未报告次要终点
