Cerebral PalsyNCT02595411
Reliability of the Melbourne Assessment
An observational study of Cerebral Palsy and Stroke, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The aim of the study is to investigate the reliability of the Melbourne Assessment. Read more about this study
- Who is it for?
- Ages 30 months to 20 years
- Conditions the study is for
- Cerebral Palsy, Stroke, Traumatic Brain Injury
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Dec 2016
- Phase
- Observational
- 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 30 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with central motor disorders and impaired upper limb function
Who may be able to join
- 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
Who cannot join
- severe visual and/or auditory problems
- acute lesion in the to assessed upper limb
- lack of compliance
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
Affoltern am Albis, CH-8910
About this study
The aim of the study is to investigate the reliability of the Melbourne Assessment.
Read the 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.
- Conditions
- Cerebral Palsy, Stroke, Traumatic Brain Injury, Meningomyelocele, Central Nervous System Diseases
- Keywords
- Children, Rehabilitation, Upper Limb, Assessments, Outcome Measures
- Medical subject headings
- Cerebral Palsy, Stroke, Brain Injuries, Traumatic, Meningomyelocele, Central Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Melbourne Assessment 2
Assessment to measure unilateral upper limb function
Measured: 2 assessments within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubertus van Hedel, PD Dr., Principal investigator, University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595411
- Sponsor's protocol ID
- MA_Reliability_2015
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Melbourne Assessment
- ClinicalTrials.gov ID
- NCT02595411
- Acronym / sponsor ID
- MA_Reliability_2015
- Conditions
- Cerebral Palsy, Stroke, Traumatic Brain Injury, Meningomyelocele, Central Nervous System Diseases
- Keywords
- Children, Rehabilitation, Upper Limb, Assessments, Outcome Measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Nov 2015 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with central motor disorders and impaired upper limb function
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- severe visual and/or auditory problems
- acute lesion in the to assessed upper limb
- lack of compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Melbourne Assessment 2
Time frame: 2 assessments within 1 week
Assessment to measure unilateral upper limb function
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 7 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Hubertus van Hedel, PD Dr. principal investigator
University Children's Hospital Zurich, Rehabilitation Centre Affoltern am Albis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Stroke, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 5 inclusion and 3 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 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Melbourne Assessment 2 (time frame: 2 assessments within 1 week). 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 7 Feb 2017.