Reliability of the Melbourne Assessment | NCT02595411

Studies
Reliability of the Melbourne Assessment

NCT02595411

Sponsor

University Children's Hospital, Zurich

Status

Completed

Last Update Posted

Feb 7, 2017Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Cerebral Palsy
Stroke
Traumatic Brain Injury
Meningomyelocele
Central Nervous System Diseases

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Nov 2, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to investigate the reliability of the Melbourne Assessment.

Detailed Description

Children with central motor disorders will be tested twice within one week with the Melbourne Assessment. The assessments will be video scored. At a later time point, different raters will rate the same video for inter-rater reliability, the same rater will score the same video for intra-rater reliability, and the same rater will score the repeated assessment videos for test-retest reliability.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Melbourne Assessment 2	Assessment to measure unilateral upper limb function	2 assessments within 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

central motor disorders
ambulant or stationary patients of the Rehabilitation Center Affoltern am Albis
ability to understand test instructions
ability to sit upright for 25 minutes
minimal activity in the assessed upper limb

Exclusion Criteria:

severe visual and/or auditory problems
acute lesion in the to assessed upper limb
lack of compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Months

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Children with central motor disorders and impaired upper limb function

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hubertus van Hedel, PD Dr.	University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis		Affoltern am Albis		CH-8910	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D020521	Stroke
D000070642	Brain Injuries, Traumatic
D008591	Meningomyelocele
D002493	Central Nervous System Diseases

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D009422	Nervous System Diseases
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided