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

NCT03876730 | Completed

• 1 other identifier: Sefaunes
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Lower Extremity Orthosis; ICF Core Set

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• ICF CP Core Set

  10 minutes

Study Arms (1)

Study group

3-18 aged children with cerebral palsy

Other: ICF CP Core Set

Interventions

ICF CP Core Set OTHER

Core set

Study group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priciple Investigator

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 15, 2019
• Study Start: April 2, 2018
• Primary Completion: April 5, 2019
• Study Completion: May 6, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)