NCT03023579

Brief Summary

PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM), and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children with cerebral palsy (CP). METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this study. Each child carried out the SEBT and was assessed by two examiners. To determine intra-rater reliability, the investigators calculated the intra-class correlation coefficient (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the inter-rater reliability.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

January 11, 2017

Last Update Submit

January 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The star excursion balance test

    6 months

Study Arms (1)

The star excursion balance test

EXPERIMENTAL

The star excursion balance test: simple test for dynamic balance

Other: The star excursion balance test

Interventions

The star excursion balance test

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • were aged between 4 and 12 years,
  • had a status above level II on the Gross Motor Function Classification System (GMFCS),
  • were able to understand instructions from the rater, and

You may not qualify if:

  • had history of fracture or sprain of the lower limbs over the previous 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 18, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01