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Outcome Measures

Primary Outcomes (2)

Maximum Tongue Strength
Maximum anterior and posterior tongue pressure (kPa) measured with the Iowa Oral Performance Instrument (IOPI). Participants pressed the bulb against the hard palate as forcefully as possible for 3 seconds; three trials were performed at each location and the highest value was used. Higher values indicate greater tongue strength.
Baseline and within 1 week after completion of the 4-week intervention
Tongue Endurance
Anterior and posterior tongue endurance (seconds) measured with the IOPI as the time participants maintained 50% of their maximum tongue pressure. Three trials were performed at each location and the longest duration was used. Longer duration indicates greater endurance.
Baseline and within 1 week after completion of the 4-week intervention

Secondary Outcomes (5)

Swallowing pressure
Baseline and within 1 week after completion of the 4-week intervention
Suprahyoid Muscle Activity
Baseline and within 1 week after completion of the 4-week intervention
Swallowing-Related Quality of Life (T-SWAL-QOL)
Baseline and within 1 week after completion of the 4-week intervention
Dysphagia Symptom Severity (T-EAT-10)
Baseline and within 1 week after completion of the 4-week intervention
Functional Oral Intake (FOIS)
Baseline and within 1 week after completion of the 4-week intervention

Study Arms (2)

Visual Biofeedback Group

EXPERIMENTAL

Participants performed supervised effortful swallow exercises 3 times per week for 4 weeks (12 sessions) with real-time visual biofeedback from the Iowa Oral Performance Instrument (IOPI) operated in Target Mode, with the target set at 80% of baseline maximum posterior tongue pressure.

Behavioral: Effortful swallow exercise with visual biofeedback

Non-biofeedback Group

ACTIVE COMPARATOR

Participants performed the same supervised effortful swallow exercise program 3 times per week for 4 weeks (12 sessions). The IOPI was operated in Peak Mode with the display visible only to the therapist; participants received identical verbal instructions without visual biofeedback.

Behavioral: Effortful swallow exercise without visual biofeedback

Interventions

Effortful swallow exercise with visual biofeedbackBehavioral

Supervised effortful saliva swallow exercise delivered by a speech-language therapist. Each session included five sets with 2-minute rest intervals: 16 swallows per set at 15-second intervals in weeks 1-2, and 20 swallows per set at 10-second intervals in weeks 3-4. The IOPI bulb was placed at the posterior tongue. The IOPI was operated in Target Mode at 80% of baseline maximum posterior tongue pressure, and participants received real-time visual feedback when the target was reached. Correct swallow execution was confirmed by observation of hyolaryngeal movement.

Visual Biofeedback Group

Effortful swallow exercise without visual biofeedbackBehavioral

MeSH Terms

Conditions

Parkinson DiseaseDeglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Only the neurologist who performed the surface electromyography assessments was blinded to group allocation. Tongue pressure measurements and patient-reported outcomes were obtained by the unblinded speech-language therapist who delivered the intervention.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Participants were randomly assigned to one of two parallel groups: effortful swallow exercise with IOPI visual biofeedback or the same exercise without visual biofeedback.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Research Assistant, PhD

Effortful Swallow Exercise With Visual Biofeedback for Tongue Strength in Parkinson's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Visual Biofeedback Group

Non-biofeedback Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

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Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Visual Biofeedback Group

Non-biofeedback Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations