Search MeSHNCT03023579
The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy
A study testing The star excursion balance test in people with Search MeSH, run by Inje University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Search MeSH
- What is being tested?
- The star excursion balance test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- had history of fracture or sprain of the lower limbs over the previous 12 months.
About this study
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.
- Conditions
- Search MeSH
- Being tested
- The star excursion balance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The star excursion balance testOther
| Study group | Role | What they receive |
|---|---|---|
| The star excursion balance test | Experimental | The star excursion balance test: simple test for dynamic balance Receives: Other: The star excursion balance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The star excursion balance test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Search MeSHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do hyun Kim, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023579
- Sponsor's protocol ID
- DKim
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03023579
- Acronym / sponsor ID
- DKim
- Conditions
- Search MeSH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The star excursion balance test | Experimental | Other: The star excursion balance testThe star excursion balance test: simple test for dynamic balance |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- had history of fracture or sprain of the lower limbs over the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The star excursion balance test | Other | The star excursion balance test |
Primary outcome
The star excursion balance test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The star excursion balance test in people with Search MeSH, run by Inje University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The star excursion balance test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.