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

NCT ID: NCT07026032

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-06-30

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.

Conditions

Oropharyngeal Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Parkinson with dysphagia

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

Group Type: EXPERIMENTAL

Biofeedback tool

Intervention Type: OTHER

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

Parkinson with Dysphagia

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

Group Type: OTHER

Biofeedback tool

Intervention Type: OTHER

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

traditional exercises

Intervention Type: OTHER

traditional exercises were used for the control group

Interventions

Biofeedback tool

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

Intervention Type: OTHER

traditional exercises

traditional exercises were used for the control group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Cognitive impairment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Nadir

Role: STUDY_DIRECTOR

Riphah International University

Locations

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/01763 Gulalai Shafiq Khan

Identifier Type: -

Identifier Source: org_study_id