Clinical trial NCT06326593: Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn
Official title: Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inhalation Injury
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members.

Detailed description: This study will investigate the effects of Wii aerobic training in Inhalation-injury Children post-thermal burn. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into one of three groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen hospital and Embaba general hosbital after referral from dermatologist. Children will perform these exercises in a room supervisor physiotherapist.

All parents of children will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

Eligibility criteria: Inclusion Criteria:

* Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA), Burn size was measured using modified Lund and Browder charts.
* 12 Years to 17 Years (Child )
* Inhalation injury.
* All children suffering from retained secretions which did not respond to medical treatment.
* All children should be clinically and medically stable.
* All children should have the same medical treatment.

Exclusion Criteria:

* Children with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, malignancy, cardiovascular diseases, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, brain injury or hearing impairments and contractures.
* Children use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
* Children with other hormonal diseases

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: base line and 12 weeks.
measure: forced expiratory volume in 1 second (FEV1)
timeFrame: base line 12 weeks
measure: peak expiratory flow (PEF)
timeFrame: base line 12 weeks
Secondary outcomes:
measure: Upper and lower chest expansion (2nd intercostal space, xiphoid)])
timeFrame: base line 12 weeks
measure: Functional capacity 6-Minute Walk Test (6-MWT)
timeFrame: base line 12 weeks
measure: Timed Up and Go test (TUG)
timeFrame: base line 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Heba Elfeky
city: Cairo
country: Egypt
facility: Ahmed Mohamed Ahmed Abdelhady
Study officials:
References:
citation: Ferguson GD, Jelsma D, Jelsma J, Smits-Engelsman BC. The efficacy of two task-orientated interventions for children with Developmental Coordination Disorder: Neuromotor Task Training and Nintendo Wii Fit Training. Res Dev Disabil. 2013 Sep;34(9):2449-61. doi: 10.1016/j.ridd.2013.05.007. Epub 2013 Jun 7.
citation: Mombarg R, Jelsma D, Hartman E. Effect of Wii-intervention on balance of children with poor motor performance. Res Dev Disabil. 2013 Sep;34(9):2996-3003. doi: 10.1016/j.ridd.2013.06.008. Epub 2013 Jul 2.