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

NCT06307561 | Completed

• 1 other identifier: GGurzoglu
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Secondary Dystonia; Cerebral Palsy, Mixed

Keywords

Dystonia; Participation; Caregiver; Burden

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Acıbadem Atunizade Hospital: lead

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Altunizade, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dystonic Disorders; Cerebral Palsy; Dystonia

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Physiotherapist

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)