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

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: Cerebral Palsy
• Intervention / Treatment: Other: ICF CP Core Set

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; 3-18 aged children with cerebral palsy	Other: ICF CP Core Set; Core set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Berg Balance Scale (PBS)	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	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	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)	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)	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)	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	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

• Sponsor: Hacettepe University

Study record dates

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

• Keywords: Cerebral Palsy; Lower Extremity Orthosis; ICF Core Set
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Sefaunes

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