HemiplegiaNCT01157494
Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms
An observational study of Hemiplegia and Cerebral Palsy, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hemiplegia, Cerebral Palsy
- What is being tested?
- classification of hand manipulation function
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Jul 2010
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We retrospectively studied children with hemiplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy).
Who may be able to join
- clinical and instrumental (TC or RMN) diagnosis of child hemiplegia
- age > 5 years
Who cannot join
- acquired hemiplegia at the age > 3 years
- anti-spastic drug inoculations or functional surgery on the plegic UE 6 months prior to the video recordings
- severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
- pharmaco-resistant epilepsy
- behavioural disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hospital Azienda Santa Maria Nuova in Reggio Emilia
Reggio Emilia, RE, 42100
About this study
Official title: Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy Forms Proposed by Ferrari A et.al.
In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use.
The investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks.
The aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne Assessment of Unilateral Upper Limb Function.
- Conditions
- Hemiplegia, Cerebral Palsy
- Being tested
- classification of hand manipulation function
- Keywords
- cerebral palsy, hemiplegia, upper limb, assessment, classification system
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classification of hand manipulation functionOther
To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).
| Study group | Role | What they receive |
|---|---|---|
| children with hemiplegia | To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment). Receives: Other: classification of hand manipulation function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment (AHA)
correlation between the new classification of hand manipulation function and the AHA which measures the bi-manual performance, i.e. what the child usually does with the plegic hand
Measured: the 2 assessment has to be registered within 6 months
Secondary outcomes (1)
Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)
correlation between the new classification of hand manipulation function and the Melbourne Assessment which measures the bi-manual performance, i.e. what the child usually does with the plegic hand
Measured: the 2 assessment has to be registered within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Investigators
- Adriano Ferrari, MD, Study chair, University of Modena and Reggio Emilia and Hospital Santa Maria NuovaGiulia Borelli, PT, Principal investigator, Azienda USL Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157494
- Sponsor's protocol ID
- UDGEE_2010_hand_class
- Status last verified
- Apr 2010
- First submitted
- 6 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy Forms Proposed by Ferrari A et.al.
- ClinicalTrials.gov ID
- NCT01157494
- Acronym / sponsor ID
- UDGEE_2010_hand_class
- Conditions
- Hemiplegia, Cerebral Palsy
- Keywords
- cerebral palsy, hemiplegia, upper limb, assessment, classification system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Jul 2010 (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.
In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use.
The investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks.
The aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne Assessment of Unilateral Upper Limb Function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with hemiplegia | – | Other: classification of hand manipulation functionTo determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We retrospectively studied children with hemiplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy).
Key inclusion criteria (2 listed)
- clinical and instrumental (TC or RMN) diagnosis of child hemiplegia
- age > 5 years
Key exclusion criteria (5 listed)
- acquired hemiplegia at the age > 3 years
- anti-spastic drug inoculations or functional surgery on the plegic UE 6 months prior to the video recordings
- severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
- pharmaco-resistant epilepsy
- behavioural disorders
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 |
|---|---|---|
| classification of hand manipulation functionTo determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment). | Other | children with hemiplegia |
Primary outcome
Assisting Hand Assessment (AHA)
Time frame: the 2 assessment has to be registered within 6 months
correlation between the new classification of hand manipulation function and the AHA which measures the bi-manual performance, i.e. what the child usually does with the plegic hand
1 secondary outcome
Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)
Time frame: the 2 assessment has to be registered within 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 7 Jul 2010.
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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.
Adriano Ferrari, MD study chair
University of Modena and Reggio Emilia and Hospital Santa Maria Nuova
Giulia Borelli, PT principal investigator
Azienda USL Reggio Emilia
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 Hemiplegia and Cerebral Palsy, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 2 inclusion and 5 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 Jul 2010. 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 Italy. 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?
Assisting Hand Assessment (AHA) (time frame: the 2 assessment has to be registered within 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 7 Jul 2010.