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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Head-Neck Control and Sitting Balance | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | Turkey (Türkiye) |
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| Transcutaneous diaphragmatic electrical stimulation (TDES) | Device | TDES twice a week for 6 weeks |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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