The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia

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.

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Key information

Conditions

Secondary Dystonia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral Palsy, Mixed Dyskinesias Dystonia Dystonic Disorders Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem Altunizade Hospital

Istanbul, Altunizade, 34662, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Total of 20 cases CP with secondary dystonia, aged between 3-15 years were included in the study.
Obtaining voluntary consent from the family.

Exclusion criteria

Having a surgical operation procedure on the musculoskeletal system.
Receiving BoNT-A in the last 6 months.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Acıbadem Atunizade Hospital

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Mar 13, 2024
Registry last updated: Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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