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

Official title

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

Overview

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.

Interventions

• Other 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
• Other 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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07200609 · E2-25-10575

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗