Cerebral PalsyNCT01988844
Upper Limbs Assessment in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Children, run by Universidad de Granada at 1 site in Spain.
Trial summary
Cerebral palsy is the leading cause of physical disability among children. Manual dexterity and upper limbs functionality is limited between these children. The purpose of this study is to stablish a specific profile of school children with cerebral palsy based on the upper limbs assessment. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy, Children
- What is being tested?
- Assessment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Oct 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: School children with cerebral palsy.
Who may be able to join
- Cerebral palsy diagnosis.
- Aged between 6 and 10 years old.
- Children attending a school.
Who cannot join
- Severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Dexterity and Upper Limbs Functionality Assessment in School Children With Cerebral Palsy
Cerebral palsy is the leading cause of physical disability among children. Manual dexterity and upper limbs functionality is limited between these children. The purpose of this study is to stablish a specific profile of school children with cerebral palsy based on the upper limbs assessment.
Read the detailed description
While the rates of perinatal and infant mortality have declined toward the end of the last century,the rate of cerebral palsy has remained at 2 to 2.5 per 1,000 live births. A high percentage of children with cerebral palsy have difficulty keeping up with the handwriting demands at school. The neurological impairments in children with cerebral palsy frequently limit the functionality of these children taken in to account the upper limbs variables. It should be interesting to describe a clinical profile based on this assessment.
- Conditions
- Cerebral Palsy, Children
- Being tested
- Assessment
- Keywords
- functionality, Cerebral palsy, Handwriting
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Also called Evaluation, Description
The children with cerebral palsy were assessed. Different measures evaluating the upper limbs functionality are used.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Children diagnosed with cerebral palsy are included in this group. An assessment and an intervention will be carried out. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Evaluation of Disability Inventory (PEDI)
This inventory assess the key functional capabilities and performance in children between six months to seven years old. Three subscales are observed: self-care, mobility and social function. It helps you to identify areas of new functional intervention. Also, it is used to identify functional deficits.
Measured: baseline
Upper limbs functionality
The functionality is measured using the Abilhand-kids questionnaire. This questionnaire was designed to cover the widest range of children's manual activities including both unimanual and bimanual activities. For each question, the children and their parents were asked to provide their perceived difficulty to perform the activity on a three-level scale: impossible (0), difficult (1), or easy (2).
Measured: baseline
Secondary outcomes (5)
Manual dexterity
Manual dexterity is measured using the 9-hole peg test. This is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The patient is seated at a table with a small container holding nine pegs. The patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The time is recorded.
Measured: baseline
Executive function
The executive function is measured using the Porteus Maze Test. It consists of a series of mazes graded in difficulty and standardized for application to children from three years old.
Measured: baseline
Handwriting assessment
The handwriting ability is measured with the Handwriting without tears method. It is used to assess memory, letter size,space and movement control.
Measured: baseline
Range of motion
The range of motion in upper limbs is measured with a standard goniometer at different levels: elbow, wrist and fingers.
Measured: baseline
Upper limbs strength
The strength is evaluated using a digital dynamometer. The strength is measured in Newtons.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2016
- Study completionOct 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988844
- Sponsor's protocol ID
- DF0042UG
- Status last verified
- Nov 2016
- First submitted
- 13 Nov 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Dexterity and Upper Limbs Functionality Assessment in School Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01988844
- Acronym / sponsor ID
- DF0042UG
- Conditions
- Cerebral Palsy, Children
- Keywords
- functionality, Cerebral palsy, Handwriting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 20 Nov 2013 (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.
Cerebral palsy is the leading cause of physical disability among children. Manual dexterity and upper limbs functionality is limited between these children. The purpose of this study is to stablish a specific profile of school children with cerebral palsy based on the upper limbs assessment.
Detailed description
While the rates of perinatal and infant mortality have declined toward the end of the last century,the rate of cerebral palsy has remained at 2 to 2.5 per 1,000 live births. A high percentage of children with cerebral palsy have difficulty keeping up with the handwriting demands at school. The neurological impairments in children with cerebral palsy frequently limit the functionality of these children taken in to account the upper limbs variables. It should be interesting to describe a clinical profile based on this assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | Other: AssessmentChildren diagnosed with cerebral palsy are included in this group. An assessment and an intervention will be carried out. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- School children with cerebral palsy.
Key inclusion criteria (3 listed)
- Cerebral palsy diagnosis.
- Aged between 6 and 10 years old.
- Children attending a school.
Key exclusion criteria (1 listed)
- Severe cognitive impairment.
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 |
|---|---|---|
| AssessmentAlso: Evaluation, DescriptionThe children with cerebral palsy were assessed. Different measures evaluating the upper limbs functionality are used. | Other | Children with cerebral palsy |
Primary outcome
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: baseline
This inventory assess the key functional capabilities and performance in children between six months to seven years old. Three subscales are observed: self-care, mobility and social function. It helps you to identify areas of new functional intervention. Also, it is used to identify functional deficits.
Upper limbs functionality
Time frame: baseline
The functionality is measured using the Abilhand-kids questionnaire. This questionnaire was designed to cover the widest range of children's manual activities including both unimanual and bimanual activities. For each question, the children and their parents were asked to provide their perceived difficulty to perform the activity on a three-level scale: impossible (0), difficult (1), or easy (2).
5 secondary outcomes
Manual dexterity
Time frame: baseline
Executive function
Time frame: baseline
Handwriting assessment
Time frame: baseline
Range of motion
Time frame: baseline
Upper limbs strength
Time frame: baseline
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 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
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 Children, run by Universidad de Granada at 1 site in Spain.
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 2 Nov 2016. 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 Spain. 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?
Pediatric Evaluation of Disability Inventory (PEDI) (time frame: baseline). The study lists 2 primary outcomes in all. 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 2 Nov 2016.