Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn

Inhalation Injury Clinical Trial

Official title:

Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326593
• Other study ID #: P.T.REC/012/005049
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: MTI University
• Contact: Ahmed m El fahl, ph.d
• Phone: 00201097782441
• Email: nn_ee_mm_oo[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Inhalation Injury
• Respiratory Aspiration
• Wounds and Injuries

Intervention

Other:
• Wii aerobic training
Nintendo Wii Fit Wii console (Nintendo Co., Ltd, Kyoto, Japan) is the main power unit of Nintendo Wii Fit. Its software includes an interactive video games that is played with a handheld, wireless remote that senses motion and requires the participant to mimic the action of their on - screen character
• conservative chest care
Diaphragmatic deep breathing exercises Bronchial hygiene techniques Assisted cough Stretching exercises and ROM exercises for both upper and lower limbs

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Ahmed Abdelhady	Cairo
Egypt	Heba Elfeky	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity (FVC)	Forced vital capacity (FVC) will be measured by using spirometer (SP - 10 electronic hand held spirometer ) with the subject upright sitting or lying in the supine posture	base line and 12 weeks.
Primary	forced expiratory volume in 1 second (FEV1)	forced expiratory volume in 1 second (FEV1) will be measured by using spirometer(SP - 10 electronic hand held spirometer) with the subject upright sitting or lying in the supine posture	base line 12 weeks
Primary	peak expiratory flow (PEF)	peak expiratory flow (PEF) will be measured by using spirometer(SP - 10 electronic hand held spirometer ) with the subject upright sitting or lying in the supine posture	base line 12 weeks
Secondary	Upper and lower chest expansion (2nd intercostal space, xiphoid)])	chest expansion assessment	base line 12 weeks
Secondary	Functional capacity 6-Minute Walk Test (6-MWT)	that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants.	base line 12 weeks
Secondary	Timed Up and Go test (TUG)	this test is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time it takes for a person to get out of the chair, walk three meters, turn around, return to the chair and sit down.	base line 12 weeks