NCT07026032

Brief Summary

A randomized control trial will be conducted to test if there will be a significant effect or not, of biofeedback exercises vs traditional exercises for clients with oropharyngeal dysphagia in Parkinson's disease. For this purpose, 32 participants will be taken for the study. Half will be given traditional exercises where as the other half will be given exercises using the biofeedback; tongueomter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Parkinson

Outcome Measures

Primary Outcomes (1)

  • FOIS

    FOIS is a clinical tool used to assess the functional oral intake of food and liquids in patients with dysphagia. It is a 7-point observer rating clinical scale that was developed to document changes in functional oral intake of liquid and food in stroke patients. FOIS was used for baseline evaluation and post assessment of Experimental and Control group. The experimental group demonstrated a notable increase in FOIS scores, improving from 4 ± 1 at baseline to 6 ± 0 at post-assessment. This indicates significant improvements in swallowing behavior associated with the biofeedback method.

    3 Weeks

Study Arms (2)

Parkinson with dysphagia

EXPERIMENTAL

Diagnosed cases of Parkinson's disease having oropharyngeal dysphagia were taken. The experimental group received exercises through biofeedback.

Other: Biofeedback tool

Parkinson with Dysphagia

OTHER

The second group, that was the control group received traditional tongue exercises.

Other: Biofeedback toolOther: traditional exercises

Interventions

Biofeedback tool (tongueometer) will be used for experimental group, where as for control group the intervention used in traditional exercises.

Parkinson with DysphagiaParkinson with dysphagia

traditional exercises were used for the control group

Parkinson with Dysphagia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed cases of Parkinson disease
  • Diagnosed patients of oropharyngeal dysphagia with both genders

You may not qualify if:

  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Maryam Nadir

    Riphah International University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will not be aware of the treatment protocol used for their comparison group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups will be made. Group A and Group B. One group will have traditional exercises and the other will have exercises using the Biofeedback.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 18, 2025

Study Start

February 1, 2024

Primary Completion

June 6, 2024

Study Completion

June 30, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations