İnvestigating Dysphagia in Pediatric Dystonia

NCT06815757 | Active Not Recruiting

• 1 other identifier: 822426
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Dystonia is a movement disorder involving involuntary, sustained, or intermittent muscle contractions that cause abnormal postures and repetitive movements, worsened by voluntary actions or stress. It is linked to dysfunctions in the basal ganglia, thalamus, and cerebellum, affecting sensorimotor integration. In children, dystonia often coexists with other disorders like spasticity in cerebral palsy, complicating diagnosis and treatment. Dystonia can be genetic, caused by mutations, or acquired, associated with conditions such as cerebral palsy, perinatal brain injury, and metabolic disorders. A key complication of pediatric dystonia is swallowing dysfunction (oropharyngeal dysphagia), which impairs airway protection and nutrition, increasing the risk of aspiration pneumonia. Studies have shown swallowing impairments across all phases (oral, pharyngeal, and esophageal) in children with dyskinetic cerebral palsy. However, due to pathophysiological differences between dystonia and cerebral palsy, generalizing findings may lead to inaccuracies. Each dystonia subtype presents unique challenges that affect swallowing function, emphasizing the need for condition-specific assessment and interventions. This study aims to fill the research gap by exploring the clinical features of swallowing dysfunction in children with dystonia, providing insights to improve care and outcomes.

Conditions

Dystonia Disorder

Keywords

Dystonia; Pediatric; Dysphagia; DDS

Outcome Measures

Primary Outcomes (1)

• Swallowing Disorder Severity

  Swallowing disorder severity will be determined using the Dysphagia Disorder Survey (DDS), a validated tool for children aged two years and older. The DDS, which has demonstrated strong internal consistency and validity, includes 15 items divided into two sections: Part 1 assesses related factors such as body mass index, diet, independence, postural control, diet consistency, adaptive utensils, special feeding techniques, and seating alignment, while Part 2 evaluates feeding and swallowing competency, including orienting, food reception, containment, oral transport, chewing, oral-pharyngeal swallowing, post-swallow, and oesophageal swallowing. In line with the developers' recommendations, items 1 and 15 were excluded from the scoring due to weak associations with other items, resulting in total scores ranging from 0 to 34. Higher scores indicated greater swallowing disorder severity.

  Baseline

Secondary Outcomes (1)

• Aspiration Risk and Swallowing Function Assessment

  Baseline

Other Outcomes (2)

• Assessment of Oral Structure

  Baseline

• Assesment of Oral Hygiene

  Baseline

Study Arms (1)

Dystonic Children

Children diagnosed with dystonia as the predominant movement disorder

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children who were diagnosed predominant movement disorder with dystonia

You may qualify if:

• \- a confirmed neurological diagnosis, such as cerebral palsy, metabolic disorders, or genetic syndromes, with dystonia as the predominant movement disorder.

You may not qualify if:

• encompassed conditions that could interfere with the evaluation process, including active or untreated seizures and acute medical illnesses, such as mouth ulcers, tonsillitis, pharyngitis, or pneumonia.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dystonic Disorders; Dystonia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Muserref Keles, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 7, 2025
• Study Start: March 17, 2023
• Primary Completion: February 20, 2025
• Study Completion: April 17, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

TU (1)