- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03876730
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
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
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Sıhhiye
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Ankara, Sıhhiye, Turkey, 06100
- Hacettepe University
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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
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Core set
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Berg Balance Scale (PBS)
Time Frame: 3 minutes
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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.
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3 minutes
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Gross Motor Function Measurement (GMFM)-88
Time Frame: 5 minutes
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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.
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5 minutes
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Measurements of range of motions
Time Frame: 5 minutes
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Goniometer will be used to determine the range of motions.
So, the investigators will be able to investigate the correlations between orthotic and joints
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5 minutes
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Modified Ashworth Scale (MAS)
Time Frame: 5 minutes
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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.
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5 minutes
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Pediatric Quality of Life (PedsQL)
Time Frame: 5 minutes
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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.
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5 minutes
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Pediatric Functional Independence Measurement (WeeFIM)
Time Frame: 5 minutes
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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.
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5 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICF CP Core Set
Time Frame: 10 minutes
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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.
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10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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
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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