International Classification of Functioning, Disability and Health and Lower Extremity Orthoses in Cerebral Palsy

August 25, 2019 updated by: Sefa Üneş, Hacettepe University

Assessment of the Use of Lower Extremity Orthosis in Children With Cerebral Palsy Within The Scope of International Classification of Functioning, Disability and Health

International Classification of Functioning, Disability and Health (ICF) is a coding system developed to describe the health status of individuals in a universal way. The increasingly common core sets are short forms of ICF categories that are specifically selected for diseases. The aim of this study is to investigate the relationship among the lower extremity orthoses commonly used in children with cerebral palsy (CP), body structure and functions, activity and participation level, and is to determine the relationship between clinical tests and ICF CP core set. For this purpose, a total of 75 children with ages between 3 and 18 will be divided into 3 groups, including using a walking orthosis, using a resting orthosis, and using both walking and resting orthoses. Children's muscle tone, joint limitation, gross motor functions, balance skills, activity and participation levels and quality of life will be assessed with the tests frequently used in the clinic separately and with the core set in a holistic framework.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sıhhiye
      • Ankara, Sıhhiye, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The children who will come to the investigator's unit, Cerebral Palsy and Pediatric Rehabilitation

Description

Inclusion Criteria:

  • Being 3-18 age years old
  • Having the diagnosis with cerebral palsy
  • Being no Botulinum Toxin Application or no surgery for the last 6 months

Exclusion Criteria:

  • If there is any other neurological or orthopedic problem other than cerebral palsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
3-18 aged children with cerebral palsy
Core set

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Berg Balance Scale (PBS)
Time Frame: 3 minutes
PBS is a 14-item scale that assesses children's balance. Each item is scored between 0 and 4 points. As a result, the total score is given, while the low score refers to the poor balance and the high score refers to the good balance.
3 minutes
Gross Motor Function Measurement (GMFM)-88
Time Frame: 5 minutes
Children's motor ability will be assessed to investigate the correlations between the motor functions and orthosis used by child. The GMFM-88 consists of 88 items examining children's gross motor movements. Each item is scored between 0 and 3 points. The higher the child gets, the more successful the child is in gross motor functions.
5 minutes
Measurements of range of motions
Time Frame: 5 minutes
Goniometer will be used to determine the range of motions. So, the investigators will be able to investigate the correlations between orthotic and joints
5 minutes
Modified Ashworth Scale (MAS)
Time Frame: 5 minutes
MAS will be used to determine the muscle tone. MAS is a scale that shows muscle hypertone between 0 and 5. 5 means that the joint is rigid due to the increase in excess tonus while 0 means no increase in tonus.
5 minutes
Pediatric Quality of Life (PedsQL)
Time Frame: 5 minutes
PedsQL is a quality-of-life questionnaire which evaluates the situations encountered in daily life of children with CP such as dressing, self-care, school activities, speech and eating. Special PedsQL will be used in 4 different age groups, including 3-4 age specific, 5-7 age specific, 8-12 age specific and 13-18 age specific. The number of items in each age group is different, but the result of PedsQL is expressed in%, not total points. A higher score refers to a more independent child.
5 minutes
Pediatric Functional Independence Measurement (WeeFIM)
Time Frame: 5 minutes
WeeFIM is an 18-item scale that measures children's activity and participation. It consists of 18 items including self-care, sphincter control, locomotion, memory, etc. Each item is scored between 0 and 7. A higher score refers to a more independent child.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICF CP Core Set
Time Frame: 10 minutes
CP Core set consists of totally 25 items about body functions, body structure, activity, participation and environmental factors. Each item is scored within 0 to 4 points. 0 indicates that there are no problems.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

May 6, 2019

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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