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

Sponsor
Qassim University (Other)
Overall Status
Completed
CT.gov ID
NCT04350034
Collaborator
Cairo University (Other)
40
Enrollment
2
Arms
39.2
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Xbox training
  • Other: Control group
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention 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.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:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial
Actual Study Start Date :
Jun 15, 2016
Actual Primary Completion Date :
Sep 20, 2019
Actual Study Completion Date :
Sep 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Xbox training group

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).

Other: Xbox training
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.
Other Names:
  • interactive video games

    • Other: Control group
    routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.
    Other Names:
  • Standard of care

    		•
    Placebo Comparator: Control group

    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.

    Other: Control group
    routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.
    Other Names:
  • Standard of care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VO2 peak [pre-intervention (1 month after burn injury)]

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

    2. VO2 peak [after 12 weeks of treatment]

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

    Secondary Outcome Measures

    1. Isokinetic testing Muscle strength [pre-intervention (1 month after burn injury)]

      assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).

    2. Isokinetic testing Muscle strength [after 12 weeks of treatment]

      assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qassim University
    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Maged Basha, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt., Qassim University
    ClinicalTrials.gov Identifier:
    NCT04350034
    Other Study ID Numbers:
    • 2656PT
    First Posted:
    Apr 16, 2020
    Last Update Posted:
    Apr 16, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maged Basha, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt., Qassim University
    lean body mass
    VO2 Peak
    muscle strength
    Enjoyment
    Severely burned children
    Xbox Kinect
    Additional relevant MeSH terms:
    Burns

    Study Results

    No Results Posted as of Apr 16, 2020