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
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
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
NCT ID
NCT04350034
First Posted
April 9, 2020
Last Updated
April 15, 2020
Sponsor
Qassim University
Collaborators
Cairo University
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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Xbox Kinect Promote Physical Fitness and Lean Mass in Severely Burned Children
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