Inhalation InjuryNCT06326593
Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn
A study testing Wii aerobic training and conservative chest care in people with Inhalation Injury, run by MTI University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Inhalation Injury
- What is being tested?
- Wii aerobic training and conservative chest care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 22 Feb 2024to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Inhalation Injury
- Being tested
- Wii aerobic training, conservative chest care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii aerobic trainingOther
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 careOther
Diaphragmatic deep breathing exercises Bronchial hygiene techniques Assisted cough Stretching exercises and ROM exercises for both upper and lower limbs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wii aerobic training; Other: 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. Receives: Other: conservative chest care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: base line 12 weeks
Secondary outcomes (3)
Upper and lower chest expansion (2nd intercostal space, xiphoid)])
chest expansion assessment
Measured: base line 12 weeks
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.
Measured: base line 12 weeks
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.
Measured: base line 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start22 Feb 2024
- Primary completion25 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inhalation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326593
- Sponsor's protocol ID
- P.T.REC/012/005049
- Status last verified
- May 2024
- First submitted
- 14 Mar 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23747936Mombarg 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.
PubMed 23827983Elfahl 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.
PubMed 40156880
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn
- ClinicalTrials.gov ID
- NCT06326593
- Acronym / sponsor ID
- P.T.REC/012/005049
- Conditions
- Inhalation Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A): Wii aerobic training | Experimental | Other: Wii aerobic training, Other: conservative chest careThis group included 38 children with inhalation injury post thermal burn; they will receive Wii aerobic training and conservative chest care. |
| Group (B): control group | Sham comparator | Other: conservative chest careThis group included 38 children with inhalation post thermal burn; they will receive conservative chest care. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wii aerobic trainingNintendo 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 | Other | Group (A): Wii aerobic training |
| conservative chest careDiaphragmatic deep breathing exercises Bronchial hygiene techniques Assisted cough Stretching exercises and ROM exercises for both upper and lower limbs | Other | Group (A): Wii aerobic training, Group (B): control group |
Primary outcome
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
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
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
3 secondary outcomes
Upper and lower chest expansion (2nd intercostal space, xiphoid)])
Time frame: base line 12 weeks
Functional capacity 6-Minute Walk Test (6-MWT)
Time frame: base line 12 weeks
Timed Up and Go test (TUG)
Time frame: base line 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 23747936Ferguson 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.
- Background: PubMed 23827983Mombarg 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.
- Derived from this study: PubMed 40156880Elfahl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii aerobic training and conservative chest care in people with Inhalation Injury, run by MTI University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: base line and 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326593, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.