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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01988844
Other study ID # DF0042UG
Secondary ID
Status Completed
Phase N/A
First received November 13, 2013
Last updated November 1, 2016
Start date November 2013
Est. completion date October 2016

Study information

Verified date November 2016
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date October 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria:

- Cerebral palsy diagnosis.

- Aged between 6 and 10 years old.

- Children attending a school.

Exclusion Criteria:

- Severe cognitive impairment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Assessment
The children with cerebral palsy were assessed. Different measures evaluating the upper limbs functionality are used.

Locations

Country Name City State
Spain Department of Physical Therapy Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline Yes
Primary 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). baseline Yes
Secondary 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. baseline Yes
Secondary 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. baseline Yes
Secondary 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. baseline Yes
Secondary Range of motion The range of motion in upper limbs is measured with a standard goniometer at different levels: elbow, wrist and fingers. baseline Yes
Secondary Upper limbs strength The strength is evaluated using a digital dynamometer. The strength is measured in Newtons. baseline Yes
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