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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05682079
Other study ID # KirikkaleUni2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2022
Est. completion date November 15, 2022

Study information

Verified date August 2023
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.


Description:

Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy. 23 children with spastic type CP and 22 typically developing children aged 6-18 years were included in the study. After recording the demographic data, the trunk control "Trunk control measurement scale" (TCMS), the activities of daily living "Pediatric Disability Assessment Inventory" (PDI), the balance "Pediatric Berg Balance Scale" (PBDI), functional exercise capacity "2 Minute Walking Test" and respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Compared to individuals with typical development, individuals with CP had lower TCMS, PPI, PBRS, 2-minute walking test and respiratory muscle strength values (p<0.01). At the same time, it was observed that individuals with hemiparetic CP had better TCMS, PPI, PBRS scores, functional exercise capacities and respiratory muscle strength compared to individuals with diparetic disease and individuals with CP at GMFCS I level compared to individuals with other levels. It was found that there was a high correlation between trunk control, balance and functional capacity of individuals with CP. It was concluded that the influence on trunk control affects balance and functional capacity. There was also a correlation between the scales.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 15, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Being between 6-18 years old, - Having been diagnosed with spastic hemiplegic or spastic diplegic cerebral palsy, - No communication problem, - GMFCS level was determined to be between I-III. Exclusion Criteria: - The parent who will answer the form does not know Turkish, - Orthopedic surgical treatment and botulinum toxin injection in the 6 months before the study, - It was determined as having other orthopedic, neurological and cardiopulmonary diseases that may affect balance and gait.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TCMS, PEDI, respiration, GMFCS,PBS,functional capacity
The Trunk Control Measurement Scale evaluates the two main components of trunk control, static sitting balance and dynamic sitting balance. The scale includes a total of 15 items. The Pediatric Disability Assessment Inventory evaluates ADLs in individuals between the ages of 6 months and 7.5 years. It is a detailed clinical assessment scale that evaluates the functional skills and performance of individuals. Items in this section are scored as "0=cannot" and "1=can". The Pediatric Berg Balance Scale is an adapted version of the Berg Balance test for adults, which consists of 14 questions. It is a scale that consists of 14 questions and evaluates balance functionally. For the 2-minute walking test; They were asked to walk at their own pace without running for 2 minutes on a quiet, concrete walkway 15 m long. It was repeated 2 times with a 10-minute rest between each trial. Respiratory muscle strength was measured using a portable, electronic mouth pressure measuring device.

Locations

Country Name City State
Turkey Fzt. Nur Sena Güçlü Ankara Çankaya

Sponsors (3)

Lead Sponsor Collaborator
Nursena Güçlü Özel Gelisim Akademi Özel Egitim ve Rehabilitasyon Merkezi, yeni kurtulus özel egitim ve rehabilitasyon merkezi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross Motor Function Classification System (GMFCS) Level I: Walks without restraint. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is restricted. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair. 2 week
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