Cerebral PalsyNCT03876730
International Classification of Functioning, Disability and Health and Lower Extremity Orthoses in Cerebral Palsy
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- ICF CP Core Set
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2018to 6 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The children who will come to the investigator's unit, Cerebral Palsy and Pediatric Rehabilitation
Who may be able to join
- 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
Who cannot join
- If there is any other neurological or orthopedic problem other than cerebral palsy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- ICF CP Core Set
- Keywords
- Cerebral Palsy, Lower Extremity Orthosis, ICF Core Set
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICF CP Core SetOther
Core set
| Study group | Role | What they receive |
|---|---|---|
| Study group | 3-18 aged children with cerebral palsy Receives: Other: ICF CP Core Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Secondary outcomes (1)
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start2 Apr 2018
- Primary completion5 Apr 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Üneş, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876730
- Sponsor's protocol ID
- Sefaunes
- Status last verified
- Aug 2019
- First submitted
- 8 Feb 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03876730
- Acronym / sponsor ID
- Sefaunes
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Lower Extremity Orthosis, ICF Core Set
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: ICF CP Core Set3-18 aged children with cerebral palsy |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The children who will come to the investigator's unit, Cerebral Palsy and Pediatric Rehabilitation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- If there is any other neurological or orthopedic problem other than cerebral palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICF CP Core SetCore set | Other | Study group |
Primary outcome
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.
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.
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
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.
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.
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.
1 secondary outcome
ICF CP Core Set
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Berg Balance Scale (PBS) (time frame: 3 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.