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

NCT07622875 | Enrolling By Invitation

• 1 other identifier: AnkaraEtlik-FTR-ZKU-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Electrical stimulation; Diaphragmatic; Respiratory muscle

Outcome Measures

Primary Outcomes (1)

• Diaphragm Function

  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 Outcomes (1)

• Head-Neck Control and Sitting Balance

  6 weeks

Study Arms (2)

MULTIMODAL REHABILITATION GROUP

ACTIVE COMPARATOR

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

TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP

ACTIVE COMPARATOR

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; Device: Transcutaneous diaphragmatic electrical stimulation (TDES)

Interventions

Multimodal Rehabilitation BEHAVIORAL

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.

MULTIMODAL REHABILITATION GROUP; TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP

Transcutaneous diaphragmatic electrical stimulation (TDES) DEVICE

TDES twice a week for 6 weeks

TRANSCUTANEOUS DIAPHRAGMATIC ELECTRICAL STIMULATION (TDES) GROUP

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffessor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)