Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy

NCT ID: NCT05791877

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2026-11-30

Brief Summary

This proposal addresses pulmonary dysfunction in severe cerebral palsy by using a novel non-invasive respiratory sensor. The two aims of the project are to 1) provide a screening tool to detect respiratory distress and 2) Find a correlation between the degree of pulmonary dysfunction and scoliosis in children with cerebral palsy.

Detailed Description

This project proposes the utilization of a novel non-invasive real-time breathing sensor - pneuRIP- to measure pulmonary function (PF) in children with high-level cerebral palsy. Currently the standard measures of PF such as spirometry and peak flow meters are too strenuous for children and those with severe CP, as a result they have low compliance rates. The pneuRIP does not require active user participation and can passively measure PF. It consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. The pneuRIP yields indices of work of breathing (WOB) which includes the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.

The WOB indices provide a screening tool for pulmonary diagnosis and treatment, decrease the risk for pneumonia and respiratory illness, and has the potential to act as a marker for scoliosis in children with high-level CP.

The impact on the field will be to have a simple and fast way to measure pulmonary function in children and adults with severe CP and correlate this to measures of function and scoliosis severity as the effects of scoliosis, which is common in CP, on pulmonary function is unclear. Measures of motor function are classified by the Gross Motor Functional Classification System (GMFCS), ranking from I to V, with worsening disability from near normal gait in Type I to complete wheelchair use in Type V. This project will address GMFCS levels IV and V which includes people using wheelchairs. The two specific aims are a) Measure WOB indices non-invasively using the pneuRIP sensor in children with CP who use a wheelchair (GMFCS level IV, V) and validate the use of WOB indices as a screening test for pulmonary dysfunction., 2) Determine the correlation between WOB indices and the degree of scoliosis using the pneuRIP sensor in 250 children with CP who use a wheelchair (GMFCS level IV, V).

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

cerebral palsy group

Respiratory sensor will measure breathing in patients with Cerebral palsy

Group Type: EXPERIMENTAL

pneuRIP

Intervention Type: DEVICE

Respiratory sensor to measure pulmonary function

Interventions

pneuRIP

Respiratory sensor to measure pulmonary function

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects should have cerebral palsy a GMFCS levels IV, V

Exclusion Criteria

-

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tariq Rahman

Principal Research Engineer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tariq Rahman, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Research Engineer

Locations

Nemours Children's Hospital

Wilmington, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tariq Rahman, PhD

Role: CONTACT

trahman@nemours.org

6104539376

Facility Contacts

Tariq Rahman

Role: primary

trahman@nemours.org

302-651-6831

Other Identifiers

1993376

Identifier Type: -

Identifier Source: org_study_id