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NCT05050422 Clinical Trial

The Effects of Trunk Impairment on Fatigue and Balance

Cerebral Palsy Clinical Trial

Official title:
The Effects of Trunk Impairment on Fatigue and Balance in Children With CP

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05050422
Other study ID # E-60116787-020-67242
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 13, 2021
Est. completion date October 13, 2021

Study information
Verified date September 2021
Source Suleyman Demirel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fatigue is a common symptom associated with cerebral palsy (CP); it has been estimated that up to 40% of adolescents with CP experience fatigue that impacts their quality of life and daily activities. Although fatigue was stated as the primary symptom, a limited number of studies were found on secondary motor and nonmotor symptoms related to trunk control in children when the literature was examined.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 64
Est. completion date October 13, 2021
Est. primary completion date October 13, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: aged between 2-18 years old; (2) had a form of CP; (3) had the cognitive competence to participate to the all assessments. Exclusion Criteria: The sufferers who had an additional neurological or musculoskeletal disability, unstable medical conditions, any recent medical intervention (such as tendon lengthening surgery or botulinum toxin injection…) were excluded

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)
control/study group

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Suleyman Demirel University

Outcome
Type Measure Description Time frame Safety issue
Primary Trunk Impairment Scale (TIS) 1 month
Primary PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS) 1 month
Primary Pediatric Balance Scale (PBS) 1 month
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