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

NCT ID: NCT07200609

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Hemophilia A Without Inhibitor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Virtual Reality Intervention

Intervention Type: OTHER

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 engage participants' interest in the topics and require the use of the person's lower extremities.
• Each game will be played for 10 minutes during the 30-minute training session. (A total of 3 games will be played)
• Participants in VR programs typically perform active hip flexion, hip abduction, hip external and internal rotation, knee flexion and extension, ankle dorsiflexion, and plantar flexion while standing.
• Game content: Kinect Sports, Kinect Adventures and Kinect Sports Rivals.

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

Group Type: ACTIVE_COMPARATOR

Home-Based Exercise Intervention

Intervention Type: OTHER

• 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 session for each muscle
• Light resistance exercises targeting muscle groups in the lower extremities, with a 5-second contraction followed by a 5-second relaxation, performed five times per session
• Bodyweight exercises
• Balance exercises
• Posture exercises

Interventions

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 engage participants' interest in the topics and require the use of the person's lower extremities.
• Each game will be played for 10 minutes during the 30-minute training session. (A total of 3 games will be played)
• Participants in VR programs typically perform active hip flexion, hip abduction, hip external and internal rotation, knee flexion and extension, ankle dorsiflexion, and plantar flexion while standing.
• Game content: Kinect Sports, Kinect Adventures and Kinect Sports Rivals.

Intervention Type: 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 session for each muscle
• Light resistance exercises targeting muscle groups in the lower extremities, with a 5-second contraction followed by a 5-second relaxation, performed five times per session
• Bodyweight exercises
• Balance exercises
• Posture exercises

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Duygu Turker

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

E2-25-10575

Identifier Type: -

Identifier Source: org_study_id