Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
Study NCT ID:
NCT04350034
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xbox Kinect Promote Physical Fitness and Lean Mass in Severely Burned Children
Sponsor:
Qassim University
Organization:
Study Overview
Official Title:
Xbox Kinect™ to Promote Physical Fitness and Lean Mass in Severely Burned Children: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XboxBurn
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: