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OpenTrials
Completed

NCT Number: NCT07026032

Effects of Biofeedback Exercises on Severity of Dysphagia in Parkinson's Clients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

An RCT will be conducted on 32 Parkinson's patients having oropharyngeal dysphagia. FOIS and biofeedback will be used as a baseline instrument to determine the tongue strength and severity of dysphagia at the initial level of the study. The experimental group will perform tongue isometric pressure exercises using biofeedback for twelve sessions, four sessions per week. The control group will perform only traditional tongue-strengthening exercises for twelve sessions, four sessions per week. Both groups will receive therapy for 30 minutes. Both groups will undergo twelve sessions of exercises, starting after a baseline evaluation. Each patient will receive therapy for 30 minutes and have four sessions of therapy weekly. Two exercise protocols will be used. Protocol A will involve biofeedback strengthening exercises using the tongueometer. Protocol B will involve traditional tongue exercises to improve coordination and strength in tongue movement. The experimental group will be instructed to perform Protocol A while the control group will be instructed to perform Protocol B. Each group after randomization will undergo twelve sessions of exercises and baseline assessment will be taken at initial, middle, and final levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cognitive impairment

Treatment and study plan

Biofeedback tool

Other

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

Traditional exercises

Other

traditional exercises were used for the control group

Primary outcomes

  1. FOIS

    Time frame: 3 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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