Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: swallowing function training

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laviena Ce; Phone Number: 15422548954; Email: linchuangzhuce@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for a 4-week period.	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
No Intervention: The control group; No intervention will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Copka Sonpashan
• Investigators: Principal Investigator: Louis Wi, Site Coordinator of United Medical Group located in Miami

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 13, 2024
• First Submitted That Met QC Criteria: April 13, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: community - stroke dysphagia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No