NCT07620210

Brief Summary

This study aims to investigate the effectiveness of resistance swallowing rehabilitation using Chin Tuck Against Resistance (CTAR) exercises combined with an innovative swallowing pressure ball in improving swallowing function and swallowing-related quality of life among home-based older stroke patients with dysphagia. Participants will receive a 12-week swallowing rehabilitation program conducted in the home-care setting. Outcome measures include swallowing function assessments, swallowing-related quality of life, and rehabilitation adherence. The study is designed as a randomized controlled trial to explore the feasibility and clinical benefits of resistance-based swallowing rehabilitation in community and home-care environments.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P75+ for not_applicable stroke

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 18, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

May 27, 2026

Last Update Submit

June 1, 2026

Conditions

StrokeDysphagiaPost-Stroke Dysphagia

Keywords

CTARSwallowing RehabilitationSwallowing Pressure BallHome CareOlder AdultsStroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Swallowing Quality of Life Questionnaire (SWAL-QOL) Total Score

    Swallowing-related quality of life assessed using the Swallowing Quality of Life Questionnaire (SWAL-QOL). The total score ranges from 44 to 220 points, with higher scores indicating better swallowing-related quality of life.

    Baseline to Week 12

Secondary Outcomes (1)

  • GOKURI Swallowing Function and Cough Events

    Baseline to Week 12

Study Arms (2)

CTAR Combined With Innovative Swallowing Pressure Ball

EXPERIMENTAL
Device: Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training

Conventional Swallowing Rehabilitation

ACTIVE COMPARATOR
Behavioral: Conventional Swallowing Rehabilitation

Interventions

Innovative Swallowing Pressure Measurement Ball Combined With CTAR TrainingDEVICE

Participants receive Chin Tuck Against Resistance (CTAR) swallowing training combined with an innovative swallowing pressure measurement ball intervention twice daily for 12 weeks.

CTAR Combined With Innovative Swallowing Pressure Ball
Conventional Swallowing RehabilitationBEHAVIORAL

Participants receive conventional swallowing rehabilitation including tongue resistance exercise and oral motor control training.

Conventional Swallowing Rehabilitation

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age between 65 and 90 years.
  • Diagnosed with ischemic or hemorrhagic stroke more than 6 months prior to enrollment.
  • Receiving home care services from participating home care agencies.
  • Able to follow instructions and participate in swallowing training.
  • MMSE score ≥24, or adjusted according to education level.
  • Passed the second stage of the 3-step swallowing screening test.
  • Presence of post-stroke dysphagia symptoms.

You may not qualify if:

  • History of head and neck cancer or head and neck radiotherapy.
  • History of cervical spine surgery or tracheostomy.
  • Severe neurological or neuromuscular diseases affecting swallowing function.
  • Severe unstable medical conditions.
  • Current use of medications significantly affecting swallowing function or muscle tone.
  • Unable to complete the intervention or follow-up assessments.
  • Receiving tube feeding without oral intake ability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChiMei Medical Center

Tainan, Tainan City, 71004, Taiwan

RECRUITING

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

nai ching Chen, RN

CONTACT

+886 988031533dreampatty11@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to either the intervention group or control group using a parallel-group cluster-randomized design conducted in home-care settings.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

June 3, 2026

Record last verified: 2026-06

Locations

TW(1)