Cerebral PalsyNCT05791877
Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy
A study testing pneuRIP in people with Cerebral Palsy, run by Nemours Children's Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- pneuRIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects should have cerebral palsy a GMFCS levels IV, V
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Hospital
Wilmington, Delaware, 19833
About this study
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.
Read the 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
- Being tested
- pneuRIP
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneuRIPDevice
Respiratory sensor to measure pulmonary function
| Study group | Role | What they receive |
|---|---|---|
| cerebral palsy group | Experimental | Respiratory sensor will measure breathing in patients with Cerebral palsy Receives: Device: pneuRIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start2 Oct 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational study with a single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Tariq Rahman, Nemours Children's Clinic
- Investigators
- Tariq Rahman, PhD, Principal investigator, Principal Research Engineer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791877
- Sponsor's protocol ID
- 1993376
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Measurement of Pulmonary Dysfunction in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05791877
- Acronym / sponsor ID
- 1993376
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 30 Mar 2023 (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.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study with a single group
| Arm | Type | Receives |
|---|---|---|
| cerebral palsy group | Experimental | Device: pneuRIPRespiratory sensor will measure breathing in patients with Cerebral palsy |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects should have cerebral palsy a GMFCS levels IV, V
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| pneuRIPRespiratory sensor to measure pulmonary function | Device | cerebral palsy group |
Primary outcome
Presence of pulmonary dysfunction
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tariq Rahman, PhD principal investigator
Principal Research Engineer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneuRIP in people with Cerebral Palsy, run by Nemours Children's Clinic at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pulmonary dysfunction (time frame: 1 month). 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 13 Jul 2026.