Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia

Stroke Clinical Trial

Official title:

Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370390
• Other study ID #: community - stroke dysphagia
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Chao Phya Abhaibhubejhr Hospital
• Contact: Laviena Ce
• Phone: 15422548954
• Email: linchuangzhuce[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Description:

Stroke is complicated by oropharyngeal dysphagia in 29 to 81% of patients. Up to 40% of these individuals continue to experience swallowing difficulty even after a year later, which is associated with an increased risk of consequences such as aspiration pneumonia, dehydration, and malnutrition. Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age over 65 years old.
• No hospitalization within the past six months.
• With clear consciousness and able to cooperate with questionnaires and training.
• The elderly people who voluntarily participate and agree to adhere until the end of the study.
• early dysphagia.

Exclusion Criteria:

• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Physical disability.
• Simultaneously receiving other therapies that might influence this study.
• Individuals with a gastrostomy.
• Abnormalities of the oral, pharyngeal, or esophageal structures.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• swallowing function training
The group rehabilitation program comprised daily 60-minute sessions, five times per week for a duration of 4 weeks. The group rehabilitation program included: Rehabilitation oral and facial exercises, Game-based surface electromyographic biofeedback training, Participants experience sharing, Individual direct feeding training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Copka Sonpashan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized Swallowing Assessment Scale	The Standardized Swallowing Assessment Scale is a commonly used tool for evaluating swallowing function. It is widely applied in medical and rehabilitation fields to assess an individual's swallowing ability and the smooth passage of food/liquid through the esophagus. The scale ranges from 18 to 46, with lower scores indicating better swallowing function.	day 1 and day 28
Secondary	Time consumed in eating	The investigators require participants to eat a lunch according to their daily intake and habits, and count the time consumed	day 1 and day 28
Secondary	Penetration-Aspiration Scale	Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.	day 1 and day 28
Secondary	15-item Geriatric Depression Scale	The 15-item Geriatric Depression Scale (GDS-15) is a widely used screening tool designed to detect depression in elderly individuals aged 65 and older.Scores on the GDS-15 range from 0 to 15, with higher scores indicating a higher likelihood of depression. A cutoff score of 5 or higher is commonly used to indicate possible depression, although this may vary depending on the population being assessed and the purpose of the screening.	day 1 and day 28