NCT06326593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

March 14, 2024

Last Update Submit

May 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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

  • 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 Outcomes (3)

  • Upper and lower chest expansion (2nd intercostal space, xiphoid)])

    base line 12 weeks

  • Functional capacity 6-Minute Walk Test (6-MWT)

    base line 12 weeks

  • Timed Up and Go test (TUG)

    base line 12 weeks

Study Arms (2)

Group (A): Wii aerobic training

EXPERIMENTAL

This group included 38 children with inhalation injury post thermal burn; they will receive Wii aerobic training and conservative chest care.

Other: Wii aerobic trainingOther: conservative chest care

Group (B): control group

SHAM COMPARATOR

This group included 38 children with inhalation post thermal burn; they will receive conservative chest care.

Other: conservative chest care

Interventions

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

Group (A): Wii aerobic training

Diaphragmatic deep breathing exercises Bronchial hygiene techniques Assisted cough Stretching exercises and ROM exercises for both upper and lower limbs

Group (A): Wii aerobic trainingGroup (B): control group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heba Elfeky

Cairo, 6347113, Egypt

Location

Ahmed Mohamed Ahmed Abdelhady

Cairo, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 23747936BACKGROUND
  • 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.

    PMID: 23827983BACKGROUND
  • Elfahl AM, Elfeky HM. Wii Aerobic Training in Inhalation-Injury Children Post-Thermal Burn: A Randomized Controlled Trial. Physiother Res Int. 2025 Apr;30(2):e70052. doi: 10.1002/pri.70052.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lectrurer of physical therapy for general surgery and dermatology

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 22, 2024

Study Start

February 22, 2024

Primary Completion

May 25, 2024

Study Completion

May 28, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations