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Expiratory Muscle Training in Children With Cerebral Palsy (CP-EMT) 20

Noch nicht rekrutierend
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Die klinische Studie NCT07048223 (CP-EMT) ist eine interventionsstudie zur Untersuchung von Zerebralparese (CP) und hat den Status noch nicht rekrutierend. Der Start ist für 30. Juli 2025 geplant, bis 20 Teilnehmer aufgenommen werden. Durchgeführt von Istinye University wird der Abschluss für 30. März 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 22. Juli 2025 aktualisiert.
Kurzbeschreibung
This study aims to examine the effects of expiratory muscle training on posture, trunk control, balance, selective motor control, and respiratory function in children with spastic-type cerebral palsy (CP). The research focuses on evaluating an innovative rehabilitation approach that addresses common challenges observed in children with CP, such as trunk instability, reduced respiratory capacity, and postural abnormal...Mehr anzeigen
Offizieller Titel

Effects of Expiratory Muscle Training on Posture, Balance, Trunk Control, and Respiratory Function in Children With Cerebral Palsy

Erkrankungen
Zerebralparese (CP)
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • CP-EMT
  • IstinyeUni-Z.KAVRIK.001
NCT-Nummer
Studienbeginn (tatsächlich)
2025-07-30
Zuletzt aktualisiert
2025-07-22
Studienende (vorauss.)
2026-03-30
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
cerebral palsy
expiratory muscle training
trunk control
posture
balance
respiratory rehabilitation
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellExpiratory Muscle Training
In this group, expiratory muscle training will be administered using the POWERbreathe EX1 device, set at 50% of each participant's measured maximal expiratory pressure (MEP). Participants will be instructed to perform the exercises daily at home for a duration of 8 weeks. Interim assessments will be conducted every 10 days. Exercise compliance will be monitored using daily exercise tracking forms.
Expiratory Muscle Training
In the expiratory muscle training group, participants will receive a respiratory exercise program consisting of breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, expiratory muscle training (EMT) will be performed using the POWERbreathe EX1 device at 50% of each participant's measured maximal expiratory pressure (MEP). Participants will be instructed to perform 25 repetitions ...Mehr anzeigen
Schein-VergleichspräparatSham Expiratory Muscle Training
In the sham expiratory muscle training group, participants will perform a respiratory exercise program including breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, sham expiratory muscle training will be administered using the POWERbreathe EX1 device set at 10% of the participant's measured maximal expiratory pressure (MEP), providing minimal resistance. Participants will be i...Mehr anzeigen
Sham Expiratory Muscle Training
In the sham expiratory muscle training group, participants will perform a respiratory exercise program including breathing control, diaphragmatic breathing, and thoracic expansion exercises. In addition, sham expiratory muscle training will be administered using the POWERbreathe EX1 device set at 10% of the participant's measured maximal expiratory pressure (MEP), providing minimal resistance. Participants will be i...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Respiratory Muscle Strength Assessment (MIP/MEP)
Before treatment, week 8
Peak Cough Flow
before treatment, week 8
Assessment of Posture (PostureScreen App)
before treatment, week 8
Trunk Control Assessment (ProKin Star Excursion Balance Test, Trunk Control Measurement Scale (TCMS))
Trunk control will be assessed using the Trunk Control Measurement Scale (TCMS) and the ProKin Star Excursion Balance Test. The TCMS evaluates static and dynamic trunk control in children with cerebral palsy. Scores range from 0 to 58, with higher scores indicating better trunk control. The ProKin Star Excursion Balance Test measures postural stability and trunk coordination using a computerized force platform. Assessments will be conducted before treatment and at the end of the 8th week.
Before treatment, week 8
Balance Assessment (PROKIN®)
before treatmant, week 8
Selective Motor Control Assessment (SCALE), (Noraxon MyoMotion)
Selective motor control will be assessed using the Selective Control Assessment of the Lower Extremity (SCALE). The SCALE evaluates the ability to perform isolated joint movements in the lower limbs and is scored bilaterally. Each limb can score from 0 to 10 points, with a total possible score ranging from 0 to 20. Higher scores indicate better selective voluntary motor control. Additionally, Noraxon MyoMotion will be used to collect objective kinematic data to support the SCALE assessment.
before treatment, week 8
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Communication Function Classification System (CFCS)
The Communication Function Classification System (CFCS) is a five-level classification system used to describe everyday communication performance in individuals with cerebral palsy. Levels range from I (most effective communicator) to V (least effective communicator). Lower levels indicate more effective and independent communication abilities.
before treatment
Gross Motor Function Classification System (GMFCS)
The Gross Motor Function Classification System (GMFCS) is a five-level system used to classify gross motor function in children with cerebral palsy. Levels range from I (most independent) to V (most limited). Lower levels represent better motor function and greater independence in mobility.
before treatment
Muscle Tone Evaluation (Modified Ashworth Scale (MAS))
Muscle tone will be assessed using the Modified Ashworth Scale (MAS), a widely used clinical tool for measuring spasticity. The scale ranges from 0 to 4, with an additional score of 1+ to indicate slight increases in muscle tone. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates a rigid limb in flexion or extension. Higher scores reflect greater spasticity.
before treatment
Gross Motor Function Measure (GMFM)
Gross motor function will be evaluated using selected sections of the Gross Motor Function Measure (GMFM-88), a standardized observational tool developed to assess changes in motor function in children with cerebral palsy. In this study, only dimensions D (Standing) and E (Walking, Running, and Jumping) will be administered. Each item is scored on a 4-point ordinal scale from 0 (does not initiate) to 3 (completes the activity). Scores will be expressed as a percentage of the maximum possible score for the selected dimensions, with higher percentages indicating better gross motor performance.
before treatment, week 8
Modified Functional Reach Test (MFRT)
Dynamic balance will be assessed using the Modified Functional Reach Test (MFRT), which evaluates the maximum distance an individual can reach forward and laterally while maintaining a fixed base of support in a seated position. The test is performed in three directions: forward, right, and left. The distance is measured in centimeters. Higher reach distances indicate better dynamic sitting balance and trunk stability.
before treatment, week 8
Prone Plank Test
Core endurance will be assessed using the Prone Plank Test, which measures the amount of time an individual can maintain a prone plank position (forearms and toes supporting the body, body in a straight line) without losing form. The test is performed on a flat surface, and time is recorded in seconds. A longer duration indicates greater core muscle endurance.
before treatment, week 8
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
12 Years
Zugelassene Geschlechter
Alle
  • Diagnosis of cerebral palsy
  • Age between 12 and 18 years
  • Gross Motor Function Classification System (GMFCS) Level I or II
  • Communication Function Classification System (CFCS) Level I, II, or III
  • Spasticity graded as 0, 1, 1+, or 2 on the Modified Ashworth Scale
  • No history of Botulinum Toxin-A injection or orthopedic surgery within the past 6 months

  • Spasticity graded as 3 or 4 on the Modified Ashworth Scale Uncontrolled seizures
  • Presence of congenital cardiopulmonary disease, autism spectrum disorder, balance-impairing conditions, or significant visual/hearing impairments
  • Acute respiratory tract infection
Istinye University logoIstinye University
Zentrale Studienkontakte
Kontakt: Zeynep KAVRIK, +905076884614, [email protected]
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