The Effects of Trunk Impairment on Fatigue and Balance

NCT ID: NCT05050422

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2021-10-13

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIAGNOSTIC_TEST

control/study group

Study

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIAGNOSTIC_TEST

control/study group

Interventions

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

control/study group

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Duray

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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E-60116787-020-67242

Identifier Type: -

Identifier Source: org_study_id

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