NCT05682079

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 23, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

December 23, 2022

Last Update Submit

August 31, 2023

Conditions

Keywords

Trunk ControlRespiratory Muscle StrengthBalance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

children with cerebral palsy

After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements.

Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity

typical kids

After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements.

Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity

Interventions

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.

children with cerebral palsytypical kids

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 6-18 years

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fzt. Nur Sena Güçlü

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Respiration

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • saniye aydoğan arslan

    kırıkkale üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
fizyoterapist

Study Record Dates

First Submitted

December 23, 2022

First Posted

January 12, 2023

Study Start

August 15, 2022

Primary Completion

October 15, 2022

Study Completion

November 15, 2022

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations