Transcutaneous Diaphragmatic Electrical Stimulation and Pulmonary Function in Non-Ambulatory Cerebral Palsy

May 31, 2026 updated by: Zeynep Kıraç Ünal, Ankara Etlik City Hospital

Effects of Transcutaneous Diaphragmatic Electrical Stimulation Added to a Multimodal Rehabilitation Program on Pulmonary Functions in Non-Ambulatory Children With Cerebral Palsy

Does transcutaneous diaphragmatic electrical stimulation (TDES), added to a 6-week structured multimodal rehabilitation program, improve diaphragm function, head-neck control, and sitting balance in children with cerebral palsy at GMFCS Level IV-V?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Baseline clinical and demographic data of patients meeting the inclusion criteria will be recorded in detail. Subsequently, participants will be randomly assigned into two groups using a computer-generated randomization method. All patients will receive a 6-week multimodal rehabilitation program consisting of conventional exercises and electrical stimulation to the lower extremity muscles five days per week, in addition to 45-minute sessions of robotic rehabilitation, 45-minute occupational therapy, 45-minute hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly. The pulmonary rehabilitation program will include diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition to these treatments, patients in the intervention group will receive transcutaneous diaphragmatic electrical stimulation (TDES).

TDES will be administered by a blinded researcher using a four-channel, low-frequency biphasic neuromuscular electrical stimulator (Compex SP 4.0, Mouguerre, France). Rectangular electrodes will be positioned in the parasternal region adjacent to the xiphoid process and at the sixth and seventh intercostal spaces along the midaxillary line. Stimulation will be delivered using biphasic waves at a frequency of 30 Hz, a pulse width of 400 μs, and a ramp-up time of 0.7 seconds. Current intensity will be gradually increased, in accordance with established protocols, until visible diaphragmatic contractions are achieved. Intervention sessions will be administered twice weekly for 30 minutes per session over a 6-week period.

Assessments will be performed before rehabilitation (week 0) and after completion of the program (week 6) by a blinded researcher other than the investigator administering TDES. In children using braces due to scoliosis, all measurements will be performed without the brace.

The effects of TDES added to a multimodal rehabilitation program on pulmonary function, head-neck control, and sitting balance, as well as related factors, will be investigated in non-ambulatory children with cerebral palsy.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with Cerebral Palsy (GMFCS Level IV-V)
  • Aged 5-18 years

Exclusion Criteria:

  • Clinically unstable condition,
  • Tracheostomy, home-based non-invasive mechanical ventilation (CPAP/BIPAP), continuous oxygen therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MULTIMODAL REHABILITATION GROUP
In addition to conventional exercises and electrical stimulation to the lower extremity muscles performed 5 days per week for 6 weeks, participants will receive 45 minutes of robotic rehabilitation, 45 minutes of occupational therapy, 45 minutes of hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly, including diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning.
Behavioral: Multimodal Rehabilitation
Conventional exercises and electrical stimulation to the lower extremity muscles 5 days per week for 6 weeks, in addition to twice-weekly sessions of robotic rehabilitation, occupational therapy, hydrotherapy, and pulmonary rehabilitation program.
Active Comparator: TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP
In addition to conventional exercises and electrical stimulation to the lower extremity muscles performed 5 days per week for 6 weeks, participants will receive 45 minutes of robotic rehabilitation, 45 minutes of occupational therapy, 45 minutes of hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly, including diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition, patients in this group will receive transcutaneous diaphragmatic electrical stimulation (TDES) twice weekly for 30 minutes per session over a 6-week period.
Behavioral: Multimodal Rehabilitation
Conventional exercises and electrical stimulation to the lower extremity muscles 5 days per week for 6 weeks, in addition to twice-weekly sessions of robotic rehabilitation, occupational therapy, hydrotherapy, and pulmonary rehabilitation program.
Device: Transcutaneous diaphragmatic electrical stimulation (TDES)
TDES twice a week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragm Function
Time Frame: 6 weeks

Using ultrasound, the diaphragm thickness (mm) and the diaphragm thickening fraction (TF %) will be measured and evaluated. During the measurements, children will be positioned in the semi-Fowler's position (30-45°) or, in appropriate cases, in the supine position, and the measurements will be taken from the right hemidiaphragm. In the ultrasound examination, a high-frequency linear probe (8-10 MHz) will be advanced along the midclavicular line toward the midpoint of the anterior axillary line and positioned at the junction between the seventh and eighth costal cartilages. The thickness of the diaphragm, which appears hyperechoic on the outer surface and hypoechoic on the inner surface, will be measured at the end of inspiration and expiration. Children will not be asked to exert maximum effort during the measurement. The thickness of the diaphragm muscle will be measured at the end of expiration (Texp) and the end of inspiration (Tinsp).

TF (%) = (Tinsp - Texp) / Texp × 100
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head-Neck Control and Sitting Balance
Time Frame: 6 weeks
the A and B subdomains of the Gross Motor Function Measure-88 (GMFM-88). The Gross Motor Function Measure-88 (GMFM-88) Subscale A scores between 0 and 51, while Subscale B scores between 0 and 60; higher scores indicate better gross motor function.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraEtlik-FTR-ZKU-01

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

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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