Back to resultsThe Effects of Trunk Impairment on Fatigue and Balance
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)
Sponsored by
About this trial
This is an interventional screening trial for Cerebral Palsy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Study
Arm Description
Outcomes
Primary Outcome Measures
Trunk Impairment Scale (TIS)
PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS)
Pediatric Balance Scale (PBS)
Secondary Outcome Measures
Full Information
NCT ID
NCT05050422
First Posted
September 13, 2021
Last Updated
September 13, 2021
Sponsor
Suleyman Demirel University
1. Study Identification
Unique Protocol Identification Number
NCT05050422
Brief Title
The Effects of Trunk Impairment on Fatigue and Balance
Official Title
The Effects of Trunk Impairment on Fatigue and Balance in Children With CP
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 13, 2021 (Anticipated)
Primary Completion Date
October 13, 2021 (Anticipated)
Study Completion Date
October 13, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Study
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)
Intervention Description
control/study group
Primary Outcome Measure Information:
Title
Trunk Impairment Scale (TIS)
Time Frame
1 month
Title
PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS)
Time Frame
1 month
Title
Pediatric Balance Scale (PBS)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Trunk Impairment on Fatigue and Balance
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