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

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: Xbox training; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 peak	determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.	pre-intervention (1 month after burn injury)
VO2 peak	determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.	after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isokinetic testing Muscle strength	assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).	pre-intervention (1 month after burn injury)
Isokinetic testing Muscle strength	assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).	after 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2016
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ACTUAL): September 20, 2019

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: muscle strength; lean body mass; Enjoyment; VO2 Peak; Severely burned children; Xbox Kinect
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 2656PT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No