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

NCT07200609 | Not Yet Recruiting

• 1 other identifier: E2-25-10575
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

virtual reality; home-based exercise; joint health; body structure and function; activity; participation

Outcome Measures

Primary Outcomes (3)

• Hemophilia Joint Health Score (HJHS)

  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.

  From enrollment to the end of treatment at 8 weeks

• Physical Activity Questionnaire for Children (PAQ-C)

  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.

  From enrollment to the end of treatment at 8 weeks

• CHO-KLAT (Canadian Hemophilia Outcomes-Kids' Life Assessment Tool)

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (12)

• 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

Study Arms (2)

Virtual reality group

EXPERIMENTAL

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

Other: Virtual Reality Intervention

Home-Based Exercise Group

ACTIVE COMPARATOR

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

Other: Home-Based Exercise Intervention

Interventions

Virtual Reality Intervention 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.

Virtual reality group

Home-Based Exercise Intervention 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

Home-Based Exercise Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The cases included in the study will be randomly divided into two groups using the web-based www.randomizer.org application. Group 1 is the virtual reality group, and Group 2 is the home-based exercise group.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 1, 2025
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share