Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults

Chimei Medical Center

Status: Enrolling

Conditions: Dysphagia; Stroke; Post-Stroke Dysphagia

Treatments: Device: Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training; Behavioral: Conventional Swallowing Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07620210

CMMC11404013

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

CTAR Combined With Innovative Swallowing Pressure Ball

Experimental group

Treatment:

Device: Innovative Swallowing Pressure Measurement Ball Combined With CTAR Training

Conventional Swallowing Rehabilitation

Active Comparator group

Treatment:

Behavioral: Conventional Swallowing Rehabilitation