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

Обзор

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.

Вмешательства

• Устройство Leap Motion-based Virtual Reality Therapy
  Arm 1 - Experimental (Leap Motion + Routine Hand Rehabilitation) Intervention Description: Participants will receive standard postoperative hand rehabilitation plus Leap Motion-based virtual reality training. The VR training will be performed for 20 minutes per day, 5 days per week, for 4 weeks, in addition to routine rehabilitation. The Leap Motion Controller tracks hand and finger movements without physical contact and allows participants to practice functional tasks and grasp patterns in a v
• Другое Active Comparator - Routine Rehabilitation Only
  Participants will receive only routine postoperative hand rehabilitation, performed for 1 hour per day, 5 days per week, for 4 weeks, supervised by a therapist.

Первичные конечные точки

• Upper limb disability/function [Срок оценки: Baseline and 4 weeks post-treatment]
• Joint range of motion (ROM) [Срок оценки: Baseline and 4 weeks post-treatment]
• Grip strength [Срок оценки: Baseline and 4 weeks post-treatment]

Критерии участия

Критерии включения

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

Критерии исключения

Communication problems

Cognitive impairment

Additional musculoskeletal, neurological, or rheumatological diseases affecting upper extremity function

Multiple trauma cases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07201740 · KC-KABLANOGLU-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗