Down SyndromeNCT07425353
Rebound Therapy on Ventilatory Functions in Down Syndrome
A study testing Chest Physical Therapy Protocol and Rebound Therapy Protocol in people with Down Syndrome, run by Beni-Suef University.
Trial summary
The purpose of this study is to examine the effects of rebound therapy on ventilatory functions in children with Down Syndrome. Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Chest Physical Therapy Protocol and Rebound Therapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2026to 22 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages will be ranged from 9 to 13 years old.
- Mild and moderate mental retardation with IQ level between 50-70 based on Stanford-Binet intelligence scale.
- Functional hearing and vision.
- Independent standing and walking.
Who cannot join
- Symptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Rebound Therapy on Ventilatory Functions in Children With Down Syndrome. A Randomized Controlled Trial
The purpose of this study is to examine the effects of rebound therapy on ventilatory functions in children with Down Syndrome.
Read the detailed description
Down syndrome (DS) is one of the common congenital anomalies associated with a high rate of various medical disorders including congenital cardiac defects, visual and auditory affection, musculoskeletal system, and autoimmune disorders. Respiratory involvement is common in DS and is a leading cause of death. Rebound therapy from quality of mini trampoline provides all benefits of other aerobic exercise without the stress impact usually associated with vigrous activity. Several studies support the use of rebound therapy among different areas while, there is no research conducted on ventilatory functions in children with Down Syndrome. Hence, there is need to study the effect of rebount therapy on ventilatory functions in children with Down Syndrome.
Fourty children with Down syndrome (based on power analysis) from both sexes (9-13 years) will be recruited from different schools of special education. They will be divided randomly into control group (20 children) and study group (20 children). The control group will receive a chest physical therapy protocol that included respiratory exercises and incentive spirometer training. The study group will receive a rebound therapy using mini trampoline.
- Conditions
- Down Syndrome
- Being tested
- Chest Physical Therapy Protocol, Rebound Therapy Protocol
- Keywords
- Mini-Trampoline, Spirometry, Down Syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Physical Therapy ProtocolOther
The chest physical therapy protocol include respiratory exercises and incentive spirometer training.
Rebound Therapy ProtocolOther
The chest physical therapy protocol include respiratory exercises and incentive spirometer training + rebound therapy protocol using mini-trampoline training
| Study group | Role | What they receive |
|---|---|---|
| Chest Physical Therapy Protocol | Active comparator | Children with Down Syndrome will receive a chest physical therapy exercises Receives: Other: Chest Physical Therapy Protocol |
| Rebound Therapy Protocol | Experimental | Children with Down Syndrome will receive a chest physical therapy exercises in addition to rebound therapy using mini trampoline. Receives: Other: Chest Physical Therapy Protocol; Other: Rebound Therapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Spirometry will be used to measure forced vital capacity (FVC). It is the maximum volume of gas that can be expired when the child exhales as forcefully and as rapidly as possible after a maximal inspiration to assess the overall ability to move air in and out of the lungs. It is expressed in liter/minute.
Measured: Up to 12 weeks
Forced Expiratory Volume in the First Second (FEV1)
Spirometry will be used to measure forced expiratory volume in the first second (FEV1). It is the volume of gas expired over a given time interval (the first second) from the beginning of the FVC maneuver that reflects airflow in the large airways. It is expressed in liter/minute.
Measured: Up to 12 weeks
Secondary outcomes (2)
Chest Expansion
Tape measures will be used to measure chest expansion.
Measured: Up to 12 weeks
Functional Mobility
Six-minute walk test will be used for measuring functional mobility. It is a sub-maximal test of aerobic capacity, in which the subjects walk as far as possible in 6 minutes (min.) around a premeasured distance
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start22 Feb 2026 (estimated)
- Primary completion22 May 2026 (estimated)
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wagdy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425353
- Sponsor's protocol ID
- P.T.REC/012/006209
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rebound Therapy on Ventilatory Functions in Children With Down Syndrome. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07425353
- Acronym / sponsor ID
- P.T.REC/012/006209
- Conditions
- Down Syndrome
- Keywords
- Mini-Trampoline, Spirometry, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 22 Feb 2026 (estimated)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 20 Feb 2026 (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 purpose of this study is to examine the effects of rebound therapy on ventilatory functions in children with Down Syndrome.
Detailed description
Down syndrome (DS) is one of the common congenital anomalies associated with a high rate of various medical disorders including congenital cardiac defects, visual and auditory affection, musculoskeletal system, and autoimmune disorders. Respiratory involvement is common in DS and is a leading cause of death. Rebound therapy from quality of mini trampoline provides all benefits of other aerobic exercise without the stress impact usually associated with vigrous activity. Several studies support the use of rebound therapy among different areas while, there is no research conducted on ventilatory functions in children with Down Syndrome. Hence, there is need to study the effect of rebount therapy on ventilatory functions in children with Down Syndrome.
Fourty children with Down syndrome (based on power analysis) from both sexes (9-13 years) will be recruited from different schools of special education. They will be divided randomly into control group (20 children) and study group (20 children). The control group will receive a chest physical therapy protocol that included respiratory exercises and incentive spirometer training. The study group will receive a rebound therapy using mini trampoline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest Physical Therapy Protocol | Active comparator | Other: Chest Physical Therapy ProtocolChildren with Down Syndrome will receive a chest physical therapy exercises |
| Rebound Therapy Protocol | Experimental | Other: Chest Physical Therapy Protocol, Other: Rebound Therapy ProtocolChildren with Down Syndrome will receive a chest physical therapy exercises in addition to rebound therapy using mini trampoline. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages will be ranged from 9 to 13 years old.
- Mild and moderate mental retardation with IQ level between 50-70 based on Stanford-Binet intelligence scale.
- Functional hearing and vision.
- Independent standing and walking.
Key exclusion criteria (5 listed)
- Symptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
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 |
|---|---|---|
| Chest Physical Therapy ProtocolThe chest physical therapy protocol include respiratory exercises and incentive spirometer training. | Other | Chest Physical Therapy Protocol, Rebound Therapy Protocol |
| Rebound Therapy ProtocolThe chest physical therapy protocol include respiratory exercises and incentive spirometer training + rebound therapy protocol using mini-trampoline training | Other | Rebound Therapy Protocol |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: Up to 12 weeks
Spirometry will be used to measure forced vital capacity (FVC). It is the maximum volume of gas that can be expired when the child exhales as forcefully and as rapidly as possible after a maximal inspiration to assess the overall ability to move air in and out of the lungs. It is expressed in liter/minute.
Forced Expiratory Volume in the First Second (FEV1)
Time frame: Up to 12 weeks
Spirometry will be used to measure forced expiratory volume in the first second (FEV1). It is the volume of gas expired over a given time interval (the first second) from the beginning of the FVC maneuver that reflects airflow in the large airways. It is expressed in liter/minute.
2 secondary outcomes
Chest Expansion
Time frame: Up to 12 weeks
Functional Mobility
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Related trials for Down Syndrome
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
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.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Physical Therapy Protocol and Rebound Therapy Protocol in people with Down Syndrome, run by Beni-Suef University.
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 5 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Wagdy, PH.D (01008079576, Eman.wagdy@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.