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NCT Number: NCT03876730

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICF CP Core Set

Other

Core set

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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. 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.

  6. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 15, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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