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

Primary Purpose

Blood Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
virtual reality
Physical Exercise
Sponsored by
Afnan Bkri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Disease focused on measuring Virtual reality ,SCD, physiotherapy , rehabilitatation , pediatric, Blood diseases

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    virtual reality treatment

    Exercise programs

    Arm Description

    Virtual reality treatment

    Congenital physical therapy exercise

    Outcomes

    Primary Outcome Measures

    The Wong-Baker Pain Faces Scale
    pain

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 11, 2023
    Sponsor
    Afnan Bkri
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05952817
    Brief Title
    Physiotherapy for Children With Sickle Cell Disease: A Randomized Controlled Trial
    Acronym
    RCT
    Official Title
    The Effect of Virtual Reality on Pain and Musculoskeletal Dysfunction in Children With Sickle Cell Disease: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    September 9, 2023 (Anticipated)
    Study Completion Date
    October 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Afnan Bkri

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Disease
    Keywords
    Virtual reality ,SCD, physiotherapy , rehabilitatation , pediatric, Blood diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    control group,i ntervention group
    Masking
    Participant
    Masking Description
    children with Blood diseases
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    virtual reality treatment
    Arm Type
    Experimental
    Arm Description
    Virtual reality treatment
    Arm Title
    Exercise programs
    Arm Type
    Other
    Arm Description
    Congenital physical therapy exercise
    Intervention Type
    Device
    Intervention Name(s)
    virtual reality
    Intervention Description
    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)
    Intervention Type
    Procedure
    Intervention Name(s)
    Physical Exercise
    Intervention Description
    Rehabilitation program of exercise
    Primary Outcome Measure Information:
    Title
    The Wong-Baker Pain Faces Scale
    Description
    pain
    Time Frame
    6. weeks
    Secondary Outcome Measure Information:
    Title
    The PedsQL™
    Description
    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
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Afnan ahmed Bkri, Bachelor
    Phone
    0583774624
    Email
    bkriafnan@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed monawer albdri, Bachelor
    Phone
    0505787807
    Email
    sway-me2009@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    afaf shaheen shaheen, PHD
    Organizational Affiliation
    King Saud University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Undecided until i get the registration and starting the study
    Citations:
    PubMed Identifier
    30362236
    Citation
    Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Statistical Analysis Plan
    Available IPD/Information URL
    https://pubmed.ncbi.nlm.nih.gov/11561673/
    Available IPD/Information Identifier
    PMID: 11561673

    Learn more about this trial

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

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