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

Hacettepe University

Status: Not yet enrolling

Conditions: Hemophilia A Without Inhibitor

Treatments: Other: Home-Based Exercise Intervention; Other: Virtual Reality Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07200609

E2-25-10575

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Virtual reality group

Experimental group

Description:

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

Treatment:

Other: Virtual Reality Intervention

Home-Based Exercise Group

Active Comparator group

Description:

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

Treatment:

Other: Home-Based Exercise Intervention