Transcutaneous Diaphragmatic Electrical Stimulation and Pulmonary Function in Non-Ambulatory Cerebral Palsy
Effects of Transcutaneous Diaphragmatic Electrical Stimulation Added to a Multimodal Rehabilitation Program on Pulmonary Functions in Non-Ambulatory Children With Cerebral Palsy
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Ankara, Turkki (Türkiye)
- Ankara Etlik City Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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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.
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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.
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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.
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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.
TDES twice a week for 6 weeks
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Diaphragm Function
Aikaikkuna: 6 weeks
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Head-Neck Control and Sitting Balance
Aikaikkuna: 6 weeks
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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.
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6 weeks
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- AnkaraEtlik-FTR-ZKU-01
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