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

Burns Clinical Trial

— XboxBurn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350034
• Other study ID #: 2656PT
• Status: Completed
• Phase: N/A
• Start date: June 15, 2016
• Est. completion date: September 20, 2019

Study information

• Verified date: April 2020
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Qassim University	Cairo University

References & Publications (3)

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. — View Citation

Hettiaratchy S, Papini R. Initial management of a major burn: II--assessment and resuscitation. BMJ. 2004 Jul 10;329(7457):101-3. Review. — View 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. Epub 2006 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 peak	determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.	pre-intervention (1 month after burn injury)
Primary	VO2 peak	determined using a Graded Exercise Test (GXT) using a modified Bruce protocol treadmill test.	after 12 weeks of treatment
Secondary	Isokinetic testing Muscle strength	assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).	pre-intervention (1 month after burn injury)
Secondary	Isokinetic testing Muscle strength	assessed using a Biodex dynamometer (Biodex Medical System, Shirley, NY,USA ).	after 12 weeks of treatment