NCT06307561|Completed
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Sponsor study identifier
observational
20
1 country
1
Study Start
January 1, 2021
Actual (reported)Primary Completion
January 1, 2024
Actual (reported)Study Completion
January 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)January 1, 2024
Actual (reported)January 1, 2024
Actual (reported)March 6, 2024
Actual (reported)March 13, 2024
Actual (reported)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).
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.
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.
Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
Acıbadem Altunizade Hospital
Istanbul, Altunizade, 34662, Turkey (Türkiye)
20 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2024
First Posted
March 13, 2024
Study Start
January 1, 2021
Actual (reported)baseline
Contact the study team to confirm eligibility.
Primary Completion
January 1, 2024
Actual (reported)Study Completion
January 1, 2024
Actual (reported)Last Updated
March 13, 2024
Record last verified: 2024-03
Individual participant data will not be made available to other researchers.
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Source: ClinicalTrials.gov.
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