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

Sponsor
Ankara Etlik City Hospital
Study ID
NCT07622875
Status
Enrolling By Invitation

Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

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.
  • Transcutaneous diaphragmatic electrical stimulation (TDES) — DEVICE
    TDES twice a week for 6 weeks

Study Details

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?

Key Dates

First listed
Jun 3, 2026
Start date
Apr 15, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Diaphragm Function [ Time Frame: 6 weeks ]

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