- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326593
Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed m El fahl, ph.d
- Phone Number: 00201097782441
- Email: nn_ee_mm_oo@yahoo.com
Study Contact Backup
- Name: Heba m El feky, ph.d
- Phone Number: 00201014450994
- Email: hebaelfeky61@yahoo.com
Study Locations
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Cairo, Egypt
- Recruiting
- Ahmed Mohamed Ahmed Abdelhady
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Contact:
- Ahmed El Fahl, ph.d
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Cairo, Egypt, 6347113
- Recruiting
- Heba Elfeky
-
Contact:
- ahmed m el fahl, phd
- Phone Number: 00201097782441
- Email: nn_ee_mm_oo@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group (A): Wii aerobic training
This group included 38 children with inhalation injury post thermal burn; they will receive Wii aerobic training and conservative chest care.
|
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
Diaphragmatic deep breathing exercises Bronchial hygiene techniques Assisted cough Stretching exercises and ROM exercises for both upper and lower limbs
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Sham Comparator: Group (B): control group
This group included 38 children with inhalation post thermal burn; they will receive conservative chest care.
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Diaphragmatic deep breathing exercises Bronchial hygiene techniques Assisted cough Stretching exercises and ROM exercises for both upper and lower limbs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced vital capacity (FVC)
Time Frame: base line and 12 weeks.
|
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
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base line and 12 weeks.
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forced expiratory volume in 1 second (FEV1)
Time Frame: base line 12 weeks
|
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)
Time Frame: base line 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper and lower chest expansion (2nd intercostal space, xiphoid)])
Time Frame: base line 12 weeks
|
chest expansion assessment
|
base line 12 weeks
|
Functional capacity 6-Minute Walk Test (6-MWT)
Time Frame: base line 12 weeks
|
that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants.
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base line 12 weeks
|
Timed Up and Go test (TUG)
Time Frame: base line 12 weeks
|
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.
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base line 12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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