Secondary DystoniaNCT06307561
The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia
An observational study of Secondary Dystonia and Cerebral Palsy, Mixed, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Secondary Dystonia, Cerebral Palsy, Mixed
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
Who may be able to join
- Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
- Obtaining voluntary consent from the family.
Who cannot join
- Having a surgical operation procedure on the musculoskeletal system.
- Receiving BoNT-A in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Altunizade Hospital
Istanbul, Altunizade, 34662
About this study
Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.
Read the detailed description
It's an observational study. Purpose of the study: Investigating the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.
- Does dystonia severity affect participation in daily life activities in CP children with secondary dystonia?
- Does the severity of dystonia in children with CP with secondary dystonia affect the burden on the caregiver?
- Are the participation in daily living activities and caregiver burden of children with CP with secondary dystonia related to each other?
Total of 20 CP cases with secondary dystonia who applied to Acıbadem University Department of Pediatric Neurosurgery will be included in the study.
Dystonia severity of these cases will be evaluated with the Barry-Albright Dystonia Scale (BADS). Children's participation in daily living activities will be evaluated with The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), and the burden on the caregiver will be evaluated with the Care and Comfort Hypertonicity Questionnaire (CCHQ).
- Conditions
- Secondary Dystonia, Cerebral Palsy, Mixed
- Keywords
- Dystonia, Participation, Caregiver, Burden
- Medical subject headings
- Dystonic Disorders, Cerebral Palsy, Dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
The Barry-Albright Dystonia Scale (BADS)
The Barry-Albright Dystonia Scale designed for secondary dystonia and presence of dystonia in various body parts. It is a 5-point, criterion-based, ordinal scale designed to assess dystonia in eight body regions: eyes, mouth, neck, trunk, and the four extremities. Raters score dystonia as none (0), slight (1), mild (2), moderate (3), or severe (4).
Measured: baseline
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) is a measure of caregivers' perceptions of activity limitations, health status, well-being, and ease of care for children with severe cerebral palsy (CP). The CPCHILD consists of 36 items comprising the following domains: (1) Personal Care; (2) Positioning, Transfer, and Mobility; (3) Communication and Social Interaction; (4) Comfort, Emotions, and Behavior; (5) Health; and (6) Overall Quality Of Life.
Measured: baseline
The Care and Comfort Hypertonicity Questionnaire (CCHQ)
The Care and Comfort Hypertonicity Questionnaire (CCHQ) is an interview questionnaire consisting of 27 questions divided into four scales: personal care,positioning/transferring, comfort and interaction/communication. Questions are answeredusing a 7-point Likert scale; mean scale score is calculated. The interview takes approximately10 min to administer. It provides a measure of functional limitation and has some quality-of-life elements with questions relating to pain and self-esteem. It indicates disease severity interms of degree of disability.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jan 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary DystoniaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Gurzoglu, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307561
- Sponsor's protocol ID
- GGurzoglu
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia
- ClinicalTrials.gov ID
- NCT06307561
- Acronym / sponsor ID
- GGurzoglu
- Conditions
- Secondary Dystonia, Cerebral Palsy, Mixed
- Keywords
- Dystonia, Participation, Caregiver, Burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 13 Mar 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.
Dystonia is the most common movement disorder in the pediatric population after spasticity. It can affect normal motor development and cause significant motor retardation. The presence of dystonia may affect motor function, pain, and ease of care in CP. Additionally, it can cause serious difficulties in daily living activities and social participation and long-term joint deformity. The increase in the severity of dystonia in CP children with secondary dystonia may affect the quality of life, activity and participation of the children, as well as the caregiver. The importance of caregivers is an undeniable fact, especially in these patient groups. This study aims to investigate the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.
Detailed description
It's an observational study. Purpose of the study: Investigating the burden of dystonia severity on the participation in daily living activities and caregivers of children with CP with secondary dystonia.
- Does dystonia severity affect participation in daily life activities in CP children with secondary dystonia?
- Does the severity of dystonia in children with CP with secondary dystonia affect the burden on the caregiver?
- Are the participation in daily living activities and caregiver burden of children with CP with secondary dystonia related to each other?
Total of 20 CP cases with secondary dystonia who applied to Acıbadem University Department of Pediatric Neurosurgery will be included in the study.
Dystonia severity of these cases will be evaluated with the Barry-Albright Dystonia Scale (BADS). Children's participation in daily living activities will be evaluated with The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), and the burden on the caregiver will be evaluated with the Care and Comfort Hypertonicity Questionnaire (CCHQ).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
Key inclusion criteria (2 listed)
- Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
- Obtaining voluntary consent from the family.
Key exclusion criteria (2 listed)
- Having a surgical operation procedure on the musculoskeletal system.
- Receiving BoNT-A 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.
Primary outcome
The Barry-Albright Dystonia Scale (BADS)
Time frame: baseline
The Barry-Albright Dystonia Scale designed for secondary dystonia and presence of dystonia in various body parts. It is a 5-point, criterion-based, ordinal scale designed to assess dystonia in eight body regions: eyes, mouth, neck, trunk, and the four extremities. Raters score dystonia as none (0), slight (1), mild (2), moderate (3), or severe (4).
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD)
Time frame: baseline
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) is a measure of caregivers' perceptions of activity limitations, health status, well-being, and ease of care for children with severe cerebral palsy (CP). The CPCHILD consists of 36 items comprising the following domains: (1) Personal Care; (2) Positioning, Transfer, and Mobility; (3) Communication and Social Interaction; (4) Comfort, Emotions, and Behavior; (5) Health; and (6) Overall Quality Of Life.
The Care and Comfort Hypertonicity Questionnaire (CCHQ)
Time frame: baseline
The Care and Comfort Hypertonicity Questionnaire (CCHQ) is an interview questionnaire consisting of 27 questions divided into four scales: personal care,positioning/transferring, comfort and interaction/communication. Questions are answeredusing a 7-point Likert scale; mean scale score is calculated. The interview takes approximately10 min to administer. It provides a measure of functional limitation and has some quality-of-life elements with questions relating to pain and self-esteem. It indicates disease severity interms of degree of disability.
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 13 Mar 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 Secondary Dystonia and Cerebral Palsy, Mixed, 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 2 inclusion and 2 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 13 Mar 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?
The Barry-Albright Dystonia Scale (BADS) (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 13 Mar 2024.