Cerebral Palsy, Spastic QuadriplegicNCT06591689
Relationship Between Communication and Gross Motor Function in Quadriparetic Cerebral Palsy
An observational study of Cerebral Palsy, Spastic Quadriplegic and Communication Disorder, Childhood, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Cerebral Palsy, Spastic Quadriplegic, Communication Disorder, Childhood, Gross Motor Delay
- What is being tested?
- Evaluation of Cases with Quadriparetic Cerebral Palsy
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Aug 2024
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Twenty quadriparetic cerebral palsy individuals between the ages of 0-17 were included in the study.
Who may be able to join
- Ages between 0-17,
- Diagnosed with quadriparetic cerebral palsy,
- Participants and parents willing to participate in the study voluntarily.
Who cannot join
- Having different types of cerebral palsy such as dyskinetic, ataxic and mixed type,
- Having spastic diparetic or hemiparetic type cerebral palsy,
- Having any history of surgery on the musculoskeletal system,
- Having received Botulinum Toxin injections in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Communication Function and Gross Motor Function in Patients With Quadriparetic Cerebral Palsy
Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments persist. In this study, the researchers aimed to examine the relationship between communication function, gross motor function and functional independence level.
Read the detailed description
This study is an observational study conducted with data obtained from assessment scales and does not involve any treatment. The target population of the study consists of individuals diagnosed with quadriparetic cerebral palsy (QCP). Individuals with QCP aged 0-17 years were included in the study. Detailed medical histories were taken from the participants, and they were evaluated using the Communication Function Classification System (CFCS), the Pediatric Functional Independence Measure (WeeFIM), and the Gross Motor Function Measure-88 (GMFM-88). The aim of this study is to examine the effect of communication function on gross motor function and independence.
- Conditions
- Cerebral Palsy, Spastic Quadriplegic, Communication Disorder, Childhood, Gross Motor Delay
- Being tested
- Evaluation of Cases with Quadriparetic Cerebral Palsy
- Medical subject headings
- Cerebral Palsy, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Cases with Quadriparetic Cerebral PalsyOther
20 quadriparetic cerebral palsy cases were evaluated with the Communication Function Classification System (CFCS), Pediatric Functional Independence Scale (WeeFIM) and Gross Motor Function Measure-88 (GMFM-88).
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Function Classification System (CFCS)
The communication functions of patients were evaluated using the "Communication Function Classification System (CFCS)." CFCS assesses the daily communication performance of individuals with cerebral palsy (CP) across five levels. It evaluates all methods that affect communication performance, such as speech, facial expressions, gestures, eye contact, facial cues, and the use of augmentative and alternative communication methods. In CFCS, Level I indicates a better condition, while Level V represents more impaired situations.
Measured: 1 month
The Pediatric Functional Independence Measure (WeeFIM)
The Pediatric Functional Independence Measure (WeeFIM) is a useful, brief, and comprehensive assessment method for identifying the functional limitations of children with developmental disorders. It consists of 18 items under the categories of self-care, sphincter control, transfers, mobility, communication, and social interaction. Each item is scored between 1 and 7. A child receives a score of 1 when performing an item with full assistance, and a score of 7 when completing it independently, safely, and in a timely manner. Afterwards, all scores are summed to calculate a percentage of independence. The WeeFIM assessments were carried out by physiotherapists based on information obtained from families. High scores on this scale indicate a high level of independence.
Measured: 1 month
The Gross Motor Function Measure-88 (GMFM-88)
The Gross Motor Function Measure-88 (GMFM-88) was used to determine the functional performance of children. GMFM-88 is a standardized, validated observational scale, and it is mandatory to use the user manual for scoring each item. GMFM-88 evaluates five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking. Each section is assessed individually, and a percentage score is calculated. The total score is obtained by averaging the percentage scores of the five sections. The items in the sections are scored as 0, 1, 2, or 3. The GMFM-88 scores were calculated by physiotherapists in strict adherence to the user manual. Total GMFM-88 score is evaluated out of 100, and higher scores indicate good gross motor development.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, Spastic QuadriplegicStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Demir, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591689
- Sponsor's protocol ID
- Ali Demir
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2024
- Last updated
- 19 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Communication Function and Gross Motor Function in Patients With Quadriparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06591689
- Acronym / sponsor ID
- Ali Demir
- Conditions
- Cerebral Palsy, Spastic Quadriplegic, Communication Disorder, Childhood, Gross Motor Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 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.
Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments persist. In this study, the researchers aimed to examine the relationship between communication function, gross motor function and functional independence level.
Detailed description
This study is an observational study conducted with data obtained from assessment scales and does not involve any treatment. The target population of the study consists of individuals diagnosed with quadriparetic cerebral palsy (QCP). Individuals with QCP aged 0-17 years were included in the study. Detailed medical histories were taken from the participants, and they were evaluated using the Communication Function Classification System (CFCS), the Pediatric Functional Independence Measure (WeeFIM), and the Gross Motor Function Measure-88 (GMFM-88). The aim of this study is to examine the effect of communication function on gross motor function and independence.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Twenty quadriparetic cerebral palsy individuals between the ages of 0-17 were included in the study.
Key inclusion criteria (3 listed)
- Ages between 0-17,
- Diagnosed with quadriparetic cerebral palsy,
- Participants and parents willing to participate in the study voluntarily.
Key exclusion criteria (4 listed)
- Having different types of cerebral palsy such as dyskinetic, ataxic and mixed type,
- Having spastic diparetic or hemiparetic type cerebral palsy,
- Having any history of surgery on the musculoskeletal system,
- Having received Botulinum Toxin injections in 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 |
|---|---|---|
| Evaluation of Cases with Quadriparetic Cerebral Palsy20 quadriparetic cerebral palsy cases were evaluated with the Communication Function Classification System (CFCS), Pediatric Functional Independence Scale (WeeFIM) and Gross Motor Function Measure-88 (GMFM-88). | Other | – |
Primary outcome
Communication Function Classification System (CFCS)
Time frame: 1 month
The communication functions of patients were evaluated using the "Communication Function Classification System (CFCS)." CFCS assesses the daily communication performance of individuals with cerebral palsy (CP) across five levels. It evaluates all methods that affect communication performance, such as speech, facial expressions, gestures, eye contact, facial cues, and the use of augmentative and alternative communication methods. In CFCS, Level I indicates a better condition, while Level V represents more impaired situations.
The Pediatric Functional Independence Measure (WeeFIM)
Time frame: 1 month
The Pediatric Functional Independence Measure (WeeFIM) is a useful, brief, and comprehensive assessment method for identifying the functional limitations of children with developmental disorders. It consists of 18 items under the categories of self-care, sphincter control, transfers, mobility, communication, and social interaction. Each item is scored between 1 and 7. A child receives a score of 1 when performing an item with full assistance, and a score of 7 when completing it independently, safely, and in a timely manner. Afterwards, all scores are summed to calculate a percentage of independence. The WeeFIM assessments were carried out by physiotherapists based on information obtained from families. High scores on this scale indicate a high level of independence.
The Gross Motor Function Measure-88 (GMFM-88)
Time frame: 1 month
The Gross Motor Function Measure-88 (GMFM-88) was used to determine the functional performance of children. GMFM-88 is a standardized, validated observational scale, and it is mandatory to use the user manual for scoring each item. GMFM-88 evaluates five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking. Each section is assessed individually, and a percentage score is calculated. The total score is obtained by averaging the percentage scores of the five sections. The items in the sections are scored as 0, 1, 2, or 3. The GMFM-88 scores were calculated by physiotherapists in strict adherence to the user manual. Total GMFM-88 score is evaluated out of 100, and higher scores indicate good gross motor development.
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 19 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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, Spastic Quadriplegic and Communication Disorder, Childhood, 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 4 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 19 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?
Communication Function Classification System (CFCS) (time frame: 1 month). 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 19 Sep 2024.