- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425353
Rebound Therapy on Ventilatory Functions in Down Syndrome
Effect of Rebound Therapy on Ventilatory Functions in Children With Down Syndrome. A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eman Wagdy, PH.D
- Phone Number: 01008079576
- Email: Eman.wagdy@pt.bsu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Symptomatic pain.
- Musculoskeletal problems or/ atlanto-axial instability.
- Rheumatic and congenital heart disease
- History of previous surgical operation
- Regular participation in any sport activities.
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 |
|---|---|
|
Active Comparator: Chest Physical Therapy Protocol
Children with Down Syndrome will receive a chest physical therapy exercises
|
The chest physical therapy protocol include respiratory exercises and incentive spirometer training.
|
|
Experimental: Rebound Therapy Protocol
Children with Down Syndrome will receive a chest physical therapy exercises in addition to rebound therapy using mini trampoline.
|
The chest physical therapy protocol include respiratory exercises and incentive spirometer training.
The chest physical therapy protocol include respiratory exercises and incentive spirometer training + rebound therapy protocol using mini-trampoline training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 12 weeks
|
|
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.
|
Up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Mobility
Time Frame: Up to 12 weeks
|
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
|
Up to 12 weeks
|
|
Chest Expansion
Time Frame: Up to 12 weeks
|
Tape measures will be used to measure chest expansion.
|
Up to 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006209
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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