The Effects of Trunk Impairment on Fatigue and Balance

Suleyman Demirel University

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Diagnostic Test: Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05050422

E-60116787-020-67242

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Diagnostic Test: Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)

Study

Active Comparator group

Treatment:

Diagnostic Test: Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)