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

Not Applicable

Completed

• Conditions: Oropharyngeal Dysphagia

• Registration Number: NCT07026032
• Lead Sponsor: Riphah International University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-06-06
• Study Completion: 2024-06-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
FOIS	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.

Trial Locations

Locations (1)

Fauji Foundation Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan