The Effects of Virtual Reality-Based Gamified Rehabilitation in Children With Hemophilia

Официальное название

The Effects of a Virtual Reality-Based Gamified Rehabilitation Program on Body Structure and Function, Activity, and Participation in Children With Hemophilia: A Randomized Controlled Trial

Обзор

Hemophilia is an inherited bleeding disorder caused by deficiencies or low levels of clotting factors VIII (hemophilia A) and IX (hemophilia B). It is a chronic disease that negatively affects physical function, mobility, and quality of life by causing damage to joint and muscle structures due to bleeding disorders. Traditional rehabilitation methods can sometimes be boring for children and lead to a loss of motivation. Therefore, there is a need for innovative methods that will increase treatment compliance and improve children's physical activity levels. Virtual reality (VR) technology provides a realistic and interactive environment that enables children to actively participate in the rehabilitation process. Combined with gamification elements, VR offers a fun learning and practice environment that supports the development of motor skills, reduces fear of movement, and can increase motivation for repetitive exercises. This randomized controlled trial will evaluate the effects of virtual reality-based gamified rehabilitation on joint health, pain, posture, gait function, proprioception, and quality of life. Additionally, the contribution of this intervention to changes in activity and participation levels will be demonstrated using the International Classification of Functioning, Disability, and Health (ICF) model. This study has the potential to guide future clinical practice by offering a more enjoyable and effective rehabilitation alternative for children with hemophilia. The widespread adoption of virtual reality-supported programs will be an important step in reducing physical disabilities associated with hemophilia.

Вмешательства

• Другое Virtual Reality Intervention
  The virtual reality training group will have sessions lasting 40 minutes, 3 days a week for 8 weeks. * A 30-minute VR-based training session using Kinect Xbox (5 min warm-up, 30 min VR, 5 min cool-down) * The device has an infrared camera sensor (Kinect sensor) that detects the participant's movement in real time * Even if the user's movement is not performed correctly in the game settings, the user receives visual and auditory sensory feedback about movement errors. * All games are provided to
• Другое Home-Based Exercise Intervention
  * Home-based exercise training group will also be given online exercises 3 days a week for 8 weeks. * Active/passive stretching exercises within pain limits * Patients will perform exercises at home under a supervised exercise program * They will perform exercises matching the virtual reality group in terms of exercise sequence, intensity, duration, and mode, incorporating open and closed kinetic chain movements * A 20-second stretch followed by a 20-second relaxation performed five times per se

Первичные конечные точки

• Hemophilia Joint Health Score (HJHS) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Physical Activity Questionnaire for Children (PAQ-C) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• CHO-KLAT (Canadian Hemophilia Outcomes-Kids' Life Assessment Tool) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (12)

• Stability Index [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Posture [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Multidimensional Hemophilia Pain [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Proprioception [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Functional Independence Score in Hemophilia (FISH) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Postural Sway [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Weight Distribution [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Dynamic Balance Test [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Step Length and Step Width [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Cadence (Steps per Minute) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Right/left load distribution [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Pressure distribution (foot pressure patterns) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• Hemophilia A diagnosed by a pediatric hematologist
• Boys aged 6-18
• Have moderate to severe hemophilia
• Do not exercise regularly
• Be able to move independently or with minimal support (ambulatory)
• Have the capacity to understand research instructions
• Prevent active bleeding
• Voluntary participation in expenses and parental record keeping
• Continued prophylactic treatment

Критерии исключения

• Children with active bleeding
• Those who have had lower extremity surgery
• Those with mental retardation
• Children with neurological, orthopedic, or psychological illnesses that may affect functional performance

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07200609 · E2-25-10575

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗