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临床试验/NCT07201740
NCT07201740尚未招募不适用

The Effectiveness of Leap Motion-Based Virtual Reality in the Rehabilitation of Flexor Tendon Injuries of the Hand

Kocaeli University0 个研究点目标入组 66 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

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

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)

Active Comparator

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

研究者

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

Serkan Kablanoğlu

PhD

Kocaeli University

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