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

N/ANot Yet RecruitingNCT07200609

Hacettepe University20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Interventions

Virtual Reality InterventionOTHER

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 InterventionOTHER

* 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

Eligibility

Sex: MALEMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.