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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876730
• Other study ID #: Sefaunes
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: May 6, 2019

Study information

• Verified date: August 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 6, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• ICF CP Core Set
Core set

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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