NCT06615310

Brief Summary

ultrasonographic parameters in stroke patients with dysphagia

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 13, 2024

Last Update Submit

September 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • muscle volume of thyrohyoid

    the thickness of the muscle will be measured by ultrasound

    baseline

Secondary Outcomes (1)

  • muscle volume of sternohyoid

    baseline

Study Arms (2)

dysphagia

3 Points and above according to the EAT-10 scale

Other: ultrasonograpic evaluotion

non-dysphagia

Under 3 points on the EAT-10 scale

Other: ultrasonograpic evaluotion

Interventions

The distance between the hyoid and thyroid cartilage, the volume of the geniohyoid, digastric anterior, sternohyoid and thyrohyoid muscles will be evaluated by ultrasound.

dysphagianon-dysphagia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with stroke at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital and enrolled in a rehabilitation program will be divided into 2 groups according to the presence of dysphagia (3 points and above according to the EAT-10 scale).

You may qualify if:

  • Agreeing to participate in the study,
  • Cognitive competence to understand the test instructions
  • Communication skills to respond to the test instructions.

You may not qualify if:

  • Presence of a neurological disease other than stroke that will cause difficulty in swallowing, -Being illiterate,
  • refusing to participate in the study,
  • jaw joint problem,
  • surgical intervention in the neck area that will affect ultrasound measurements,
  • infected open wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

associate proffesor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate proffesor

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 26, 2024

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

September 26, 2024

Record last verified: 2024-09