Autism Spectrum DisorderNCT06125990
Video Based Breathing Exercise Rehabilitation
A study testing Experimental: Study Group (SGr) in people with Autism Spectrum Disorder and Down Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effect of video game-based lung volume increasing training on respiratory mechanics in children with developmental delays. Individuals with special needs are people who, for various reasons, show significant awareness at the level expected from their peers in terms of their… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Down Syndrome
- What is being tested?
- Experimental: Study Group (SGr)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2023to 14 Aug 2023
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Volunteer of the family to participate in the study
- Stable clinical status at inclusion without infection or exacerbation in the previous 4 weeks
- Children who have not been included in another clinical trial within the last month
- Participants with a Body Mass Index (BMI) below 30 kilograms/square meter
Who cannot join
- Those with severe comorbidities, unstable coronary artery disease, collagen vascular diseases, and those requiring high-flow oxygen therapy (3-4 L\min).
- History of exertional syncope or any comorbidity that prevents exercise training
- Inability to communicate with the child and the child not obeying commands in any way
- Children with vision problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gedik University Barrier-Free Life Center
Istanbul
About this study
Official title: Effect of Video Game-Based Lung Volume Increasing Training on Respiratory Mechanics in Children With Developmental Delays: Randomized Controlled Study
The aim of the study was to investigate the effect of video game-based lung volume increasing training on respiratory mechanics in children with developmental delays. Individuals with special needs are people who, for various reasons, show significant awareness at the level expected from their peers in terms of their individual characteristics and educational qualifications. Individuals with special needs constitute an important part of our country. Children with special needs may have respiratory problems that may or may not be recognized because they are not diagnosed, as well as decreases in respiratory capacity. Decrease in lung volumes may be encountered in children with special needs with various diagnoses such as neuromuscular diseases, cerebral palsy, cystic fibrosis, autism, and Down syndrome.
Pulmonary rehabilitation is a multidisciplinary program that balances or reverses the physiopsychopathology of pulmonary disorders and tries to help the patient reach high functional capacity as much as his physical condition and pulmonary disability allow. Chest physiotherapy, which is an important step of pulmonary rehabilitation, is a rehabilitation intervention used to reduce airway resistance, improve gas exchange and facilitate breathing in children. Active video game systems produced with the development of new technologies are used for the positive progression of rehabilitation, especially in young individuals who are extensive users of digital devices. For children who need a pulmonary rehabilitation program, active video game systems are preferred in the clinic as they increase the compatibility of the sessions and ensure continuity.
Read the detailed description
It seems that there are insufficient studies in the literature on the effects of exercises that increase lung capacity on children with special needs. To the best of our knowledge, there is no study investigating the effects of programs to increase lung volumes in children with special needs in a randomized controlled study design. With this project, we aimed to reveal the effects of a lung volume-increasing exercise program performed with a video-based game system applied for 6 weeks in children with special needs, by comparing it with the control group that received only conventional rehabilitation. The duration of the treatment program in our study is also one of our unique values. According to our literature research, the implementation of a lung capacity-increasing rehabilitation program in children with special needs in the form of supervision twice a week and a home program once a week for 6 weeks is the first.
- Conditions
- Autism Spectrum Disorder, Down Syndrome
- Being tested
- Experimental: Study Group (SGr), Sham Comparator: Control Group (CGr)
- Keywords
- breathing exercise, video based game, biofeedback
- Medical subject headings
- Autism Spectrum Disorder, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Study Group (SGr)Other
For 6 weeks, in addition to institutional conventional exercise 2 days a week, one day a week of home exercise, breathing exercises to increase lung volumes and 7 sets of video-based breathing exercises were applied, each set consisting of 2 minutes of performance and 1 minute of rest.
Sham Comparator: Control Group (CGr)Other
Only institutional conventional rehabilitation was implemented.
| Study group | Role | What they receive |
|---|---|---|
| Study Group (SGr) | Experimental | In addition to institutional conventional rehabilitation, this group included breathing exercises to increase lung volumes and a 21-minute breathing exercise with video-based biofeedback. Receives: Other: Experimental: Study Group (SGr) |
| Control Group (CGr) | Sham comparator | This group was given only institutional conventional rehabilitation. Receives: Other: Sham Comparator: Control Group (CGr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC Measurement
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
Measured: Change from baseline lungs volumes at 6 weeks.
FEV1 Measurement
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
Measured: Change from baseline lungs volumes at 6 weeks.
FEV1/FVC Measurement
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
Measured: Change from baseline lungs volumes at 6 weeks.
PEF Measurement
Respiratory Function Test. The COSMED microQuark spirometer used. Positive airway flow rate was evaluated.
Measured: Change from baseline lungs volumes at 6 weeks.
Secondary outcomes (2)
Pulse measurement
In order to ensure exercise safety, exercise sessions were carried out by monitoring pulse and saturation values with a pulse oximeter before, during and during exercises that increase lung volumes.
Measured: Change from baseline lungs volumes at 6 weeks.
Saturation measurement
In order to ensure exercise safety, exercise sessions were carried out by monitoring pulse and saturation values with a pulse oximeter before, during and during exercises that increase lung volumes.
Measured: Change from baseline lungs volumes at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start14 Apr 2023
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Gedik University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125990
- Sponsor's protocol ID
- VideoBasedRehab
- Status last verified
- Apr 2023
- First submitted
- 18 Sep 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simmich J, Deacon AJ, Russell TG. Active Video Games for Rehabilitation in Respiratory Conditions: Systematic Review and Meta-Analysis. JMIR Serious Games. 2019 Feb 25;7(1):e10116. doi: 10.2196/10116.
PubMed 30801256Ucgun H, Gurses HN, Kaya M, Cakir E. Video game-based exercise in children and adolescents with non-cystic fibrosis bronchiectasis: A randomized comparative study of aerobic and breathing exercises. Pediatr Pulmonol. 2022 Sep;57(9):2207-2217. doi: 10.1002/ppul.26026. Epub 2022 Jun 21.
PubMed 35669989
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video Game-Based Lung Volume Increasing Training on Respiratory Mechanics in Children With Developmental Delays: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06125990
- Acronym / sponsor ID
- VideoBasedRehab
- Conditions
- Autism Spectrum Disorder, Down Syndrome
- Keywords
- breathing exercise, video based game, biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Istanbul Gedik University
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 13 Nov 2023 (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.
The aim of the study was to investigate the effect of video game-based lung volume increasing training on respiratory mechanics in children with developmental delays. Individuals with special needs are people who, for various reasons, show significant awareness at the level expected from their peers in terms of their individual characteristics and educational qualifications. Individuals with special needs constitute an important part of our country. Children with special needs may have respiratory problems that may or may not be recognized because they are not diagnosed, as well as decreases in respiratory capacity. Decrease in lung volumes may be encountered in children with special needs with various diagnoses such as neuromuscular diseases, cerebral palsy, cystic fibrosis, autism, and Down syndrome.
Pulmonary rehabilitation is a multidisciplinary program that balances or reverses the physiopsychopathology of pulmonary disorders and tries to help the patient reach high functional capacity as much as his physical condition and pulmonary disability allow. Chest physiotherapy, which is an important step of pulmonary rehabilitation, is a rehabilitation intervention used to reduce airway resistance, improve gas exchange and facilitate breathing in children. Active video game systems produced with the development of new technologies are used for the positive progression of rehabilitation, especially in young individuals who are extensive users of digital devices. For children who need a pulmonary rehabilitation program, active video game systems are preferred in the clinic as they increase the compatibility of the sessions and ensure continuity.
Detailed description
It seems that there are insufficient studies in the literature on the effects of exercises that increase lung capacity on children with special needs. To the best of our knowledge, there is no study investigating the effects of programs to increase lung volumes in children with special needs in a randomized controlled study design. With this project, we aimed to reveal the effects of a lung volume-increasing exercise program performed with a video-based game system applied for 6 weeks in children with special needs, by comparing it with the control group that received only conventional rehabilitation. The duration of the treatment program in our study is also one of our unique values. According to our literature research, the implementation of a lung capacity-increasing rehabilitation program in children with special needs in the form of supervision twice a week and a home program once a week for 6 weeks is the first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Study Group (SGr) | Experimental | Other: Experimental: Study Group (SGr)In addition to institutional conventional rehabilitation, this group included breathing exercises to increase lung volumes and a 21-minute breathing exercise with video-based biofeedback. |
| Control Group (CGr) | Sham comparator | Other: Sham Comparator: Control Group (CGr)This group was given only institutional conventional rehabilitation. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Volunteer of the family to participate in the study
- Stable clinical status at inclusion without infection or exacerbation in the previous 4 weeks
- Children who have not been included in another clinical trial within the last month
- Participants with a Body Mass Index (BMI) below 30 kilograms/square meter
Key exclusion criteria (4 listed)
- Those with severe comorbidities, unstable coronary artery disease, collagen vascular diseases, and those requiring high-flow oxygen therapy (3-4 L\min).
- History of exertional syncope or any comorbidity that prevents exercise training
- Inability to communicate with the child and the child not obeying commands in any way
- Children with vision problems
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 |
|---|---|---|
| Experimental: Study Group (SGr)For 6 weeks, in addition to institutional conventional exercise 2 days a week, one day a week of home exercise, breathing exercises to increase lung volumes and 7 sets of video-based breathing exercises were applied, each set consisting of 2 minutes of performance and 1 minute of rest. | Other | Study Group (SGr) |
| Sham Comparator: Control Group (CGr)Only institutional conventional rehabilitation was implemented. | Other | Control Group (CGr) |
Primary outcome
FVC Measurement
Time frame: Change from baseline lungs volumes at 6 weeks.
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
FEV1 Measurement
Time frame: Change from baseline lungs volumes at 6 weeks.
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
FEV1/FVC Measurement
Time frame: Change from baseline lungs volumes at 6 weeks.
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.
PEF Measurement
Time frame: Change from baseline lungs volumes at 6 weeks.
Respiratory Function Test. The COSMED microQuark spirometer used. Positive airway flow rate was evaluated.
2 secondary outcomes
Pulse measurement
Time frame: Change from baseline lungs volumes at 6 weeks.
Saturation measurement
Time frame: Change from baseline lungs volumes at 6 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 13 Nov 2023.
- Background: PubMed 30801256Simmich J, Deacon AJ, Russell TG. Active Video Games for Rehabilitation in Respiratory Conditions: Systematic Review and Meta-Analysis. JMIR Serious Games. 2019 Feb 25;7(1):e10116. doi: 10.2196/10116.
- Background: PubMed 35669989Ucgun H, Gurses HN, Kaya M, Cakir E. Video game-based exercise in children and adolescents with non-cystic fibrosis bronchiectasis: A randomized comparative study of aerobic and breathing exercises. Pediatr Pulmonol. 2022 Sep;57(9):2207-2217. doi: 10.1002/ppul.26026. Epub 2022 Jun 21.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Study Group (SGr) in people with Autism Spectrum Disorder and Down Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
FVC Measurement (time frame: Change from baseline lungs volumes at 6 weeks.). The study lists 4 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 NCT06125990, which also lists 2 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 13 Nov 2023.