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Completed

NCT Number: NCT04350034

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

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.

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xbox training

Other

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

Control Group

Other

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

Primary outcomes

  1. VO2 peak

    Time frame: pre-intervention (1 month after burn injury)

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

  2. VO2 peak

    Time frame: after 12 weeks of treatment

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

Secondary outcomes

  1. Isokinetic testing Muscle strength

    Time frame: pre-intervention (1 month after burn injury)

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

  2. Isokinetic testing Muscle strength

    Time frame: after 12 weeks of treatment

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

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial

Acronym: XboxBurn

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2020
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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