Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia

NCT06370390 | Not Yet Recruiting

• 1 other identifier: community - stroke dysphagia
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time consumed in eating

  day 1 and day 28

• Penetration-Aspiration Scale

  day 1 and day 28

• 15-item Geriatric Depression Scale

  day 1 and day 28

Study Arms (2)

the intervention group

EXPERIMENTAL

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 control group

NO INTERVENTION

No intervention will be applied

Interventions

swallowing function training 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 intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copka Sonpashan: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Louis Wi

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laviena Ce

CONTACT

15422548954; linchuangzhuce@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 17, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04