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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Physical Activity Questionnaire for Children (PAQ-C)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual reality group
Inclusion criteria:
Diagnosed with Hemophilia A by a pediatric hematologist Aged 6-18 years With moderate to severe hemophilia Not regularly exercising No active bleeding complaints Children who are willing to participate in the study and continue prophylactic treatment
Exclusion criteria:
Children with active bleeding complaints Children who have undergone lower extremity surgery Children with neurological, orthopedic, or psychological conditions that affect functional performance
干预措施: Virtual Reality Intervention (Other)
Home-Based Exercise Group
Inclusion criteria:
Diagnosed with Hemophilia A by a pediatric hematologist Aged 6-18 years With moderate to severe hemophilia Not regularly exercising No active bleeding complaints Children who are willing to participate in the study and continue prophylactic treatment
Exclusion criteria:
Children with active bleeding complaints Children who have undergone lower extremity surgery Children with neurological, orthopedic, or psychological conditions that affect functional performance
干预措施: Home-Based Exercise Intervention (Other)
结局指标
主要结局
Physical Activity Questionnaire for Children (PAQ-C)
时间窗: From enrollment to the end of treatment at 8 weeks
Target group: Children and adolescents. Objective: To determine the level of physical activity performed through play, sports, and exercise in daily life. Method: The child is asked to indicate how many times they performed the activities on the list (e.g., jumping rope, running, cycling, walking, skating, games) in the last 7 days. Answer options: Never done it = 0 points 1-2 times = 1 point 3-4 times = 2 points 5-6 times = 3 points 7 times and above = 4 points Points awarded for all activities (e.g., jumping rope, running, cycling, walking, skating, tag, etc.) are added together. This total gives the child's total physical activity score for the last 7 days.
Hemophilia Joint Health Score (HJHS)
时间窗: From enrollment to the end of treatment at 8 weeks
HJHS is a commonly used clinical assessment scale developed to evaluate joint health in patients with hemophilia. It aims to detect hemophilia-related joint damage early, particularly in children and adolescents. Purpose of development: To detect hemophilic arthropathy (joint damage) through physical examination without the need for radiological methods. Scope: The elbow, knee, and ankle joints, which are the most commonly affected joints in hemophilia patients, are evaluated. Target group: Although initially developed for children aged 4-18, it is now also used in adults. The following joint characteristics are scored in the HJHS: Joint swelling (acute/chronic) Muscle atrophy Joint pain Loss of joint range of motion (ROM) Crepitus (sound or friction sensation during joint movement) Gait (walking) assessment Scoring: These parameters are evaluated for each joint using a specific scoring system. A total score of 0 = normal joint health, a higher score = more joint damage.
CHO-KLAT (Canadian Hemophilia Outcomes-Kids' Life Assessment Tool)
时间窗: From enrollment to the end of treatment at 8 weeks
Purpose of development: To measure the daily life experiences, social participation, and quality of life of children with hemophilia. Age group: Child version (8-18 years) → Completed by the child. Parent version (for ages 0-7 and 8-18) → Based on parental observation. Includes questions that relate conditions specific to hemophilia (e.g., bleeding, treatment burden, physical limitations) to quality of life. CHO-KLAT assesses the child's life from a physical, social, and emotional perspective. The question topics are generally: School and social activities (participation, friendships, involvement in games) Physical activities (sports, games, ability to exercise) Daily living activities (mobility, care, freedom of movement) Emotional state (anxiety, feelings about illness) Experiences related to treatment (injections, access to healthcare) Each item is scored between 0 and 4 (0 = strongly disagree, 4 = strongly agree). All scores are then added up and converted to a 0-100 range.
次要结局
- Stability Index(From enrollment to the end of treatment at 8 weeks)
- Posture(From enrollment to the end of treatment at 8 weeks)
- Multidimensional Hemophilia Pain(From enrollment to the end of treatment at 8 weeks)
- Proprioception(From enrollment to the end of treatment at 8 weeks)
- Functional Independence Score in Hemophilia (FISH)(From enrollment to the end of treatment at 8 weeks)
- Postural Sway(From enrollment to the end of treatment at 8 weeks)
- Weight Distribution(From enrollment to the end of treatment at 8 weeks)
- Dynamic Balance Test(From enrollment to the end of treatment at 8 weeks)
- Step Length and Step Width(From enrollment to the end of treatment at 8 weeks)
- Cadence (Steps per Minute)(From enrollment to the end of treatment at 8 weeks)
- Right/left load distribution(From enrollment to the end of treatment at 8 weeks)
- Pressure distribution (foot pressure patterns)(From enrollment to the end of treatment at 8 weeks)
研究者
Duygu Turker
Associate Professor
Hacettepe University