Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia

NCT ID: NCT06370390

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-06-30

Brief 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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

swallowing function training

Intervention Type: BEHAVIORAL

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

The control group

No intervention will be applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copka Sonpashan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Copka Sonpashan

Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Louis Wi

Role: PRINCIPAL_INVESTIGATOR

Site Coordinator of United Medical Group located in Miami

Central Contacts

Laviena Ce

Role: CONTACT

linchuangzhuce@126.com

15422548954

Other Identifiers

community - stroke dysphagia

Identifier Type: -

Identifier Source: org_study_id