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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: pneuRIP

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).

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tariq Rahman, PhD; Phone Number: 6104539376; Email: trahman@nemours.org

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19833
      • Recruiting
      • Nemours Children's Hospital
      • Contact: Tariq Rahman; Phone Number: 302-651-6831; Email: trahman@nemours.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Study Population

Patients with cerebral palsy GMFCS level IV and V

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cerebral palsy group; Respiratory sensor will measure breathing in patients with Cerebral palsy	Device: pneuRIP; Respiratory sensor to measure pulmonary function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pulmonary dysfunction	The presence of pulmonary dysfunction will be recorded for each subject. Presence will be determined clinically by the physician. Pulmonary dysfunction can take the form of pneumonia, ineffective airway clearance or atelectasis.	1 month

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Tariq Rahman, PhD, Principal Research Engineer

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 1993376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No