Physiotherapy for Children With Sickle Cell Disease: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Primary aim to determine the effects of immersive VR on pain management in children with SCD. Secondary aim to determine the effects of immersive VR in musculoskeletal dysfunction in children with SCD and health-related quality of life.

Detailed Description
-----------------
We hypothesized that: Immersive VR would significantly improve pain in children with SCD. Immersive VR would significantly improve musculoskeletal function in children with SCD. Immersive VR would significantly improve the health quality of life according to children.

Official Title
-----------------
The Effect of Virtual Reality on Pain and Musculoskeletal Dysfunction in Children With Sickle Cell Disease: A Randomized Controlled Trial

Conditions
-----------------
Blood Disease

Intervention / Treatment
-----------------
* Device: virtual reality
* Procedure: Physical Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria are as following: patients aged between 6-18 years of both genders diagnosed with SCD, with hip avascular necrosis (AVN), with joints pain, children with SCD post hip surgery, with motor impairment and gait difficulty, with restricted ROM in lower limb, children with recent crisis of SCD. Exclusion Criteria: The exclusion criteria are the children with previous stroke or other neurologic disorders and cardiopulmonary disorders that limits the functional activities of the participants will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control group,i ntervention group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality treatment<br>Virtual reality treatment | Device: virtual reality<br>* Virtual reality (VR) technology is a new medical intervention technique founded on the principle of distraction, providing real perceptual stimuli such as visual images, spatial sounds, tactile, and sensory feedback stimuli.(Zhang et al., 2022)<br>|
| Other: Exercise programs<br>Congenital physical therapy exercise | Procedure: Physical Exercise<br>* Rehabilitation program of exercise<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Wong-Baker Pain Faces Scale | pain | 6. weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PedsQL™ | The PedsQL™ measurement model was designed as a modular approach to measuring pediatric health-related quality of life and developed to integrate the relative merits of generic and disease-specific approaches. The PedsQL™ has demonstrated reliability, validity, sensitivity, and responsiveness for child | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual reality ,SCD, physiotherapy , rehabilitatation , pediatric, Blood diseases