Upper Limbs Assessment in Children With Cerebral Palsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Universidad de Granada
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01988844
First received: November 13, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Cerebral Palsy
Children
Other: Assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Manual Dexterity and Upper Limbs Functionality Assessment in School Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Manual dexterity [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.

  • Executive function [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.

  • Handwriting assessment [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    The handwriting ability is measured with the Handwriting without tears method. It is used to assess memory, letter size,space and movement control.

  • Range of motion [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    The range of motion in upper limbs is measured with a standard goniometer at different levels: elbow, wrist and fingers.

  • Upper limbs strength [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    The strength is evaluated using a digital dynamometer. The strength is measured in Newtons.


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children with cerebral palsy
Children diagnosed with cerebral palsy are included in this group
Other: Assessment
The children with cerebral palsy were assessed. Different measures evaluating the upper limbs functionality are used.
Other Names:
  • Evaluation
  • Description

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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

School children with cerebral palsy.

Criteria

Inclusion Criteria:

  • Cerebral palsy diagnosis.
  • Aged between 6 and 10 years old.
  • Children attending a school.

Exclusion Criteria:

  • Severe cognitive impairment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988844

Contacts
Contact: Marie Carmen Valenza, PhD 958242360 cvalenza@ugr.es

Locations
Spain
Department of Physical Therapy Recruiting
Granada, Spain, 18071
Contact: Marie Carmen Valenza, PhD    958242360    cvalenza@ugr.es   
Principal Investigator: Marie Carmen Valenza, PhD         
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided

Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01988844     History of Changes
Other Study ID Numbers: DF0042UG
Study First Received: November 13, 2013
Last Updated: November 19, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad de Granada:
functionality
Cerebral palsy
Handwriting

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014