NCT05050422

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

September 13, 2021

Last Update Submit

September 13, 2021

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

  • Trunk Impairment Scale (TIS)

    1 month

  • PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS)

    1 month

  • Pediatric Balance Scale (PBS)

    1 month

Study Arms (2)

Control

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

Study

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

Interventions

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

control/study group

ControlStudy

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged between 2-18 years old; (2) had a form of CP; (3) had the cognitive competence to participate to the all assessments.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 20, 2021

Study Start

September 13, 2021

Primary Completion

October 13, 2021

Study Completion

October 13, 2021

Last Updated

September 20, 2021

Record last verified: 2021-09