NCT07425353

Brief Summary

The purpose of this study is to examine the effects of rebound therapy on ventilatory functions in children with Down Syndrome.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 22, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 15, 2026

Last Update Submit

February 15, 2026

Conditions

Keywords

Mini-TrampolineSpirometryDown Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 12 weeks

Secondary Outcomes (2)

  • Chest Expansion

    Up to 12 weeks

  • Functional Mobility

    Up to 12 weeks

Study Arms (2)

Chest Physical Therapy Protocol

ACTIVE COMPARATOR

Children with Down Syndrome will receive a chest physical therapy exercises

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.

Other: Chest Physical Therapy ProtocolOther: Rebound Therapy Protocol

Interventions

The chest physical therapy protocol include respiratory exercises and incentive spirometer training.

Chest Physical Therapy ProtocolRebound Therapy Protocol

The chest physical therapy protocol include respiratory exercises and incentive spirometer training + rebound therapy protocol using mini-trampoline training

Rebound Therapy Protocol

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Symptomatic pain.
  • Musculoskeletal problems or/ atlanto-axial instability.
  • Rheumatic and congenital heart disease
  • History of previous surgical operation
  • Regular participation in any sport activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 20, 2026

Study Start

February 22, 2026

Primary Completion

May 22, 2026

Study Completion

May 22, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02