DiparesisNCT06583746
Lower Extremity Evaluation in Children With Diparetic Cerebral Palsy According to ICF Perspective
An observational study of Diparesis and Cerebral Palsy, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP); is the most common neurodevelopmental disorder seen in childhood, characterized by permanent motor dysfunctions that develop due to brain damage occurring before birth, during birth, or in early childhood. The most common type is spastic type CP with a prevalence rate of 70-80%. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Diparesis, Cerebral Palsy, Diplegic Cerebral Palsy
- What is being tested?
- Group1
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2002to 31 Jan 2022
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with diparetic cerebral palsy between the ages of 3 and 13 were included.
Who may be able to join
- Between 3-13 years old,
- Diagnosis of diparetic cerebral palsy,
- Participants and/or parents willing to participate in the study voluntarily.
Who cannot join
- Having different types of CP such as dyskinetic, mixed, ataxic types other than spastic type,
- Having spastic quadriparetic or hemiparetic type CP,
- Having received Botulinum Toxin injections to the lower extremities within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy (CP); is the most common neurodevelopmental disorder seen in childhood, characterized by permanent motor dysfunctions that develop due to brain damage occurring before birth, during birth, or in early childhood.
The most common type is spastic type CP with a prevalence rate of 70-80%. Spastic type CP is divided into three groups as diparetic (38%), hemiparetic (39%) and quadriparetic (23%). In diparetic cerebral palsy (DCP); lower extremity involvement is more pronounced than upper extremity involvement. Typically; weakness in the trunk, postural and antigravity muscles, functional and/or structural asymmetry between both lower extremities are seen and this condition is closely related to impaired static and/or dynamic balance, decreased postural control, decreased functional performance, and low participation rate in activities.
The ICF (International Classification of Functioning, Disability, and Health) was developed by the World Health Organization in 2001 and is a comprehensive model that evaluates health status not only through the presence of diseases and disorders but also through various dimensions such as functionality, environmental, and personal factors. The ICF model includes five main components to evaluate an individual's functionality and disability: body structure and functions, activity, participation, environmental and personal factors. In recent years, functional abilities, including social participation, have increasingly become the focus of research in children with CP.
Read the detailed description
It's an observational study.
Purpose of the study: The increase in tone seen in the lower extremities in children with diparetic cerebral palsy (DCP) may adversely affect the activity and participation of children. Our study aim is to evaluate lower extremities in children with DCP according to ICF perspective.
A total of 30 cases, 15 females (50%) and 15 males (50%), aged between 3 and 13 years (mean: 5.8), who were admitted to the Pediatric Rehabilitation Department of Acıbadem Altunizade Hospital with the diagnosis of DCP between 2019 and 2022, were included in this cross-sectional study.
- What should the rehabilitation program for children with DCP include?
- What should we consider when evaluating children with DCP?
The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity, and Pediatric Functional Independence Measure (WeeFIM) was used for participation
- Being tested
- Group1
- Keywords
- Diparetic Cerebral Palsy, Lower extremity, International Classification of Function, Body structure and function, Activity, Participation
- Medical subject headings
- Cerebral Palsy, Paresis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1Other
30 children with DCP were included. The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity and Pediatric Functional Independence Measure (WeeFIM) was used for participation.
| Study group | Role | What they receive |
|---|---|---|
| Lower extremity evaluation of children with DCP within the framework of ICF | 30 children with DCP were included. The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity and Pediatric Functional Independence Measure (WeeFIM) was used for participation. Receives: Other: Group1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
It is a 6-point scale used to describe the resistance of the muscle to passive movement and the ease with which the joint can be moved within the available range. It is frequently used in clinical settings. It is quite practical to evaluate and interpret.
Measured: baseline
Gillette Functional Walking Assessment Questionnaire (FAQ)
It is a measurement tool used to evaluate walking ability and functional mobility in children. This questionnaire was developed specifically to evaluate the walking functions of children with cerebral palsy and other neuromuscular disorders. Developed at Gillette Children's Hospital, this questionnaire aims to rate children's walking abilities in different environments. It scores children's walking skills on a scale of 1-10.
Measured: baseline
Pediatric Functional Independence Scale (WeeFIM)
The WeeFIM scale is a tool used to assess children's independence levels and functional abilities. It was developed to objectively assess children's independence levels and whether they need assistance with daily living activities. The scale consists of 6 main headings and 18 subheadings. These subheadings evaluate areas such as self-care (feeding, dressing, toilet use), sphincter control, transfers (e.g. bed, chair), movement (walking, wheelchair use), communication and social cognition (problem solving, memory). Scoring ranges from 1 to 7, with the highest score being 126. As the score increases, assistance decreases and independence increases.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jan 2002
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiparesisStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilayda Sozeri, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583746
- Sponsor's protocol ID
- IlaydaS
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Evaluation in Children With Diparetic Cerebral Palsy According to ICF Perspective
- ClinicalTrials.gov ID
- NCT06583746
- Acronym / sponsor ID
- IlaydaS
- Keywords
- Diparetic Cerebral Palsy, Lower extremity, International Classification of Function, Body structure and function, Activity, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Sep 2024 (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.
Cerebral palsy (CP); is the most common neurodevelopmental disorder seen in childhood, characterized by permanent motor dysfunctions that develop due to brain damage occurring before birth, during birth, or in early childhood.
The most common type is spastic type CP with a prevalence rate of 70-80%. Spastic type CP is divided into three groups as diparetic (38%), hemiparetic (39%) and quadriparetic (23%). In diparetic cerebral palsy (DCP); lower extremity involvement is more pronounced than upper extremity involvement. Typically; weakness in the trunk, postural and antigravity muscles, functional and/or structural asymmetry between both lower extremities are seen and this condition is closely related to impaired static and/or dynamic balance, decreased postural control, decreased functional performance, and low participation rate in activities.
The ICF (International Classification of Functioning, Disability, and Health) was developed by the World Health Organization in 2001 and is a comprehensive model that evaluates health status not only through the presence of diseases and disorders but also through various dimensions such as functionality, environmental, and personal factors. The ICF model includes five main components to evaluate an individual's functionality and disability: body structure and functions, activity, participation, environmental and personal factors. In recent years, functional abilities, including social participation, have increasingly become the focus of research in children with CP.
Detailed description
It's an observational study.
Purpose of the study: The increase in tone seen in the lower extremities in children with diparetic cerebral palsy (DCP) may adversely affect the activity and participation of children. Our study aim is to evaluate lower extremities in children with DCP according to ICF perspective.
A total of 30 cases, 15 females (50%) and 15 males (50%), aged between 3 and 13 years (mean: 5.8), who were admitted to the Pediatric Rehabilitation Department of Acıbadem Altunizade Hospital with the diagnosis of DCP between 2019 and 2022, were included in this cross-sectional study.
- What should the rehabilitation program for children with DCP include?
- What should we consider when evaluating children with DCP?
The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity, and Pediatric Functional Independence Measure (WeeFIM) was used for participation
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower extremity evaluation of children with DCP within the framework of ICF | – | Other: Group130 children with DCP were included. The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity and Pediatric Functional Independence Measure (WeeFIM) was used for participation. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with diparetic cerebral palsy between the ages of 3 and 13 were included.
Key inclusion criteria (3 listed)
- Between 3-13 years old,
- Diagnosis of diparetic cerebral palsy,
- Participants and/or parents willing to participate in the study voluntarily.
Key exclusion criteria (3 listed)
- Having different types of CP such as dyskinetic, mixed, ataxic types other than spastic type,
- Having spastic quadriparetic or hemiparetic type CP,
- Having received Botulinum Toxin injections to the lower extremities within the last 6 months.
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 |
|---|---|---|
| Group130 children with DCP were included. The lower extremity evaluations of these cases were made according to ICF. Modified Ashworth Scale (MAS) was used for body structure and functions, Gillette Functional Assessment Questionnaire (FAQ) was used for activity and Pediatric Functional Independence Measure (WeeFIM) was used for participation. | Other | Lower extremity evaluation of children with DCP within the framework of ICF |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: baseline
It is a 6-point scale used to describe the resistance of the muscle to passive movement and the ease with which the joint can be moved within the available range. It is frequently used in clinical settings. It is quite practical to evaluate and interpret.
Gillette Functional Walking Assessment Questionnaire (FAQ)
Time frame: baseline
It is a measurement tool used to evaluate walking ability and functional mobility in children. This questionnaire was developed specifically to evaluate the walking functions of children with cerebral palsy and other neuromuscular disorders. Developed at Gillette Children's Hospital, this questionnaire aims to rate children's walking abilities in different environments. It scores children's walking skills on a scale of 1-10.
Pediatric Functional Independence Scale (WeeFIM)
Time frame: baseline
The WeeFIM scale is a tool used to assess children's independence levels and functional abilities. It was developed to objectively assess children's independence levels and whether they need assistance with daily living activities. The scale consists of 6 main headings and 18 subheadings. These subheadings evaluate areas such as self-care (feeding, dressing, toilet use), sphincter control, transfers (e.g. bed, chair), movement (walking, wheelchair use), communication and social cognition (problem solving, memory). Scoring ranges from 1 to 7, with the highest score being 126. As the score increases, assistance decreases and independence increases.
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 4 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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 Diparesis and Cerebral Palsy, run by Acıbadem Atunizade Hospital 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 3 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 4 Sep 2024. 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?
Modified Ashworth Scale (MAS) (time frame: baseline). The study lists 3 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 4 Sep 2024.