The treatment of stroke patients with severe and severest dysphagia by swallowing function stimulation with iced exercise boli: a clinical trial to evaluate a therapeutic treatment option

The treatment of stroke patients with severe and severest dysphagia by swallowing function stimulation with iced exercise boli: a clinical trial to evaluate a therapeutic treatment option - non

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027276

Enrollment

112

Registered

2021-11-19

Start date

2021-11-23

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I63 R13

Interventions

Group 1: Each subject is in the following groups at 3 different time points: Examination group = group with iced Jello. Group 2: Examination group = group with Ice-chips Group 3: Control group = group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with severe and severest dysphagia after stroke.

Exclusion criteria

Exclusion criteria: Patients with dysphagia of other etiologies, patients with preexisting dysphagia.

Design outcomes

Primary

Measure	Time frame
In the present study, the Yale Scale is defined as the primary endpoint. The Yale Pharyngeal Residue Severity Rating Scale (Neubauer, Rademaker, Leder 2015), which is already available in a validated German translation as the Yale-Residuen-Skala (Neubauer et al., 2015; Gerschke et al., 2019), considers the location and severity of residues after swallowing in an image-based manner. It was developed, validated, and standardized to reliably assess image-based location and severity of residues after swallowing.	—

Measure

Time frame

In the present study, the Yale Scale is defined as the primary endpoint. The Yale Pharyngeal Residue Severity Rating Scale (Neubauer, Rademaker, Leder 2015), which is already available in a validated German translation as the Yale-Residuen-Skala (Neubauer et al., 2015; Gerschke et al., 2019), considers the location and severity of residues after swallowing in an image-based manner. It was developed, validated, and standardized to reliably assess image-based location and severity of residues after swallowing.

—

Secondary

Measure	Time frame
In addition, the secretion assessment scale by Murray et al. (1996) and the 8-point penetration-aspiration scale by Rosenbek (PAS) will also be measured and evaluated as "secondary" endpoints.	—

Countries

Germany

Contacts

Public ContactSandra Hagen

Median Klinik Bad Tennstedt

Sandra.Hagen@median-kliniken.de+493604135134

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026