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Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06370390
Enrollment
200
Registered
2024-04-17
Start date
2024-04-30
Completion date
2024-06-30
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

BEHAVIORALswallowing 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

Sponsors

Copka Sonpashan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardized Swallowing Assessment Scaleday 1 and day 28The 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.

Secondary

MeasureTime frameDescription
Time consumed in eatingday 1 and day 28The investigators require participants to eat a lunch according to their daily intake and habits, and count the time consumed
Penetration-Aspiration Scaleday 1 and day 28Penetration-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.
15-item Geriatric Depression Scaleday 1 and day 28The 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.

Contacts

Primary ContactLaviena Ce
linchuangzhuce@126.com15422548954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026