NCT01988844

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

November 13, 2013

Last Update Submit

November 1, 2016

Conditions

Cerebral PalsyChildren

Keywords

functionalityCerebral palsyHandwriting

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • Manual dexterity

    baseline

  • Executive function

    baseline

  • Handwriting assessment

    baseline

  • Range of motion

    baseline

  • Upper limbs strength

    baseline

Study Arms (1)

Children with cerebral palsy

Children diagnosed with cerebral palsy are included in this group. An assessment and an intervention will be carried out.

Other: Assessment

Interventions

AssessmentOTHER

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

Also known as: Evaluation, Description
Children with cerebral palsy

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

School children with cerebral palsy.

You may qualify if:

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

You may not qualify if:

  • Severe cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, Spain, 18071, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Marie Carmen Valenza, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 20, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(1)