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Xbox Kinect Promote Physical Fitness and Lean Mass in Severely Burned Children (XboxBurn)

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xbox training
Control group
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring lean body mass, VO2 Peak, muscle strength, Enjoyment, Severely burned children, Xbox Kinect

Eligibility Criteria

10 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • total body surface area (TBSA) of 40-60%.
  • being ambulatory without an assistant.

Exclusion Criteria:

  • metabolic disorders.neuropathy.
  • visual or vestibular disorders.
  • amputation.
  • participation in another study.
  • history of epilepsy.
  • loss of balance.
  • lower or upper limb deformity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Xbox training group

    Control group

    Arm Description

    The study group received Xbox training plus routine physical therapy protocol treatment. The dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system (Xbox 360 Kinect console; Microsoft Inc., Redmond, Washington, USA).

    patients participated in a routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.

    Outcomes

    Primary Outcome Measures

    VO2 peak
    determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
    VO2 peak
    determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.

    Secondary Outcome Measures

    Isokinetic testing Muscle strength
    assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).
    Isokinetic testing Muscle strength
    assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).

    Full Information

    First Posted
    April 9, 2020
    Last Updated
    April 15, 2020
    Sponsor
    Qassim University
    Collaborators
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04350034
    Brief Title
    Xbox Kinect Promote Physical Fitness and Lean Mass in Severely Burned Children
    Acronym
    XboxBurn
    Official Title
    Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2016 (Actual)
    Primary Completion Date
    September 20, 2019 (Actual)
    Study Completion Date
    September 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qassim University
    Collaborators
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The outcome measures included quadriceps muscle strength as measured using an isokinetic dynamometer, LBM is measured by DEXA and cardiopulmonary fitness was assessed by measuring VO2 peak during a standardized treadmill exercise test using the modified Bruce protocol. All outcome measures were evaluated immediately after discharge as baseline and after 12 weeks of intervention.
    Detailed Description
    Forty healed pediatric burn patients (24 boys and 16 girls), aged 10 - 15 years, were enrolled from the outpatient clinic in the faculty of physical therapy, Cairo university, Egypt. The inclusion criteria were: total body surface area (TBSA) of 40-60%, being ambulatory without an assistant. The exclusion criteria included metabolic disorders, neuropathy, visual or vestibular disorders, amputation, participation in another study, any adverse medication reactions, history of epilepsy, loss of balance, and lower or upper limb deformity. All patients received similar standard medical care and treatment from the time of admission until the time of discharge. Total burn surface area was assessed by the "modified Lund and Browder charts" method during excisional surgery immediately following hospital admittance. Informed written consent was obtained from each patient's guardian prior to enrollment. All procedures were approved by the ethical committee of the faculty of physical therapy, Cairo university, Giza, Egypt. After consent was obtained, patients were randomly assigned to standard of care group (SOC) or Xbox training group (Xbox). The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program (N=20). In contrast, the SOC group participated in the routine physiotherapy program (N=20). A normal activity of daily living (ADL), diet and patient's lifestyle were maintained for all participants as much as possible.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns
    Keywords
    lean body mass, VO2 Peak, muscle strength, Enjoyment, Severely burned children, Xbox Kinect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    The Xbox group participated in a 12-week of routine physiotherapy program supplemented with Xbox training program. The control group participated in the routine physiotherapy program. In the study group received Xbox training, the dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system. The games were anticipated onto a 45-inch Samsung television. The playing area was 16 * 12 m. The content of Xbox training consisted of practicing five Xbox games (Rally Ball, Reflex Ridge, River Rush, 2000 Leaks and parkour). Children practiced each game for 10 min, bringing about every session enduring 50 min.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Xbox training group
    Arm Type
    Experimental
    Arm Description
    The study group received Xbox training plus routine physical therapy protocol treatment. The dose of Xbox training was 50 min, three times a week for 12 weeks, using the Xbox gaming system (Xbox 360 Kinect console; Microsoft Inc., Redmond, Washington, USA).
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    patients participated in a routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.
    Intervention Type
    Other
    Intervention Name(s)
    Xbox training
    Other Intervention Name(s)
    interactive video games
    Intervention Description
    patients in this group received routine physical therapy protocol plus Xbox training. Before the intervention started, the Xbox group was given a 45 min introductory session on how to use the xbox adventure games and its tools. All sessions were led by a single experienced physiotherapist (different to the physiotherapist who performed the assessments tests) in order to provide instruction on how to perform each exercise.
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Other Intervention Name(s)
    Standard of care
    Intervention Description
    routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.
    Primary Outcome Measure Information:
    Title
    VO2 peak
    Description
    determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
    Time Frame
    pre-intervention (1 month after burn injury)
    Title
    VO2 peak
    Description
    determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.
    Time Frame
    after 12 weeks of treatment
    Secondary Outcome Measure Information:
    Title
    Isokinetic testing Muscle strength
    Description
    assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).
    Time Frame
    pre-intervention (1 month after burn injury)
    Title
    Isokinetic testing Muscle strength
    Description
    assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).
    Time Frame
    after 12 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: total body surface area (TBSA) of 40-60%. being ambulatory without an assistant. Exclusion Criteria: metabolic disorders.neuropathy. visual or vestibular disorders. amputation. participation in another study. history of epilepsy. loss of balance. lower or upper limb deformity.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
    IPD Sharing Time Frame
    6 months after publication
    IPD Sharing Access Criteria
    IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
    Citations:
    PubMed Identifier
    22895351
    Citation
    Herndon DN, Rodriguez NA, Diaz EC, Hegde S, Jennings K, Mlcak RP, Suri JS, Lee JO, Williams FN, Meyer W, Suman OE, Barrow RE, Jeschke MG, Finnerty CC. Long-term propranolol use in severely burned pediatric patients: a randomized controlled study. Ann Surg. 2012 Sep;256(3):402-11. doi: 10.1097/SLA.0b013e318265427e.
    Results Reference
    background
    PubMed Identifier
    15242917
    Citation
    Hettiaratchy S, Papini R. Initial management of a major burn: II--assessment and resuscitation. BMJ. 2004 Jul 10;329(7457):101-3. doi: 10.1136/bmj.329.7457.101. No abstract available.
    Results Reference
    background
    PubMed Identifier
    17130281
    Citation
    Przkora R, Herndon DN, Suman OE. The effects of oxandrolone and exercise on muscle mass and function in children with severe burns. Pediatrics. 2007 Jan;119(1):e109-16. doi: 10.1542/peds.2006-1548. Epub 2006 Nov 27.
    Results Reference
    background
    PubMed Identifier
    33316436
    Citation
    Basha MA, Aboelnour NH, Aly SM, Kamel FAH. Impact of Kinect-based virtual reality training on physical fitness and quality of life in severely burned children: A monocentric randomized controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101471. doi: 10.1016/j.rehab.2020.101471. Epub 2021 Nov 23.
    Results Reference
    derived

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