Myofunctional and Respiratory Intervention on Phonation in Stroke

Effects of a Combined Myofunctional and Respiratory Intervention on Phonation in Patients With Chronic Stroke

Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Myofunctional and respiratory training program; Other: Range of motion and thermal and mechanical stimulation exercising

Detailed Description

Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. Myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. Respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. A combination of both may be of interest to improve phonation parameters.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Cabrera Martos; Phone Number: 958248763; Email: irenecm@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18016
    • Recruiting
    • Faculty of Health Sciences
    • Contact: Irene Cabrera Martos; Email: irenecm@ugr.es
    • Contact: Email: irenecm@ugr.es
    • Principal Investigator: Irene Cabrera Martos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a clinical diagnosis of chronic stroke (duration above 6 months).
• Age over 18 years

Exclusion Criteria:

• Communication or cognitive deficits that prevented them from following verbal commands.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myofunctional and respiratory training; Patients with chronic stroke receiving an exercise training program for the muscles around the face, mouth, and tongue and a respiratory training focused on inspiratory and expiratory muscle strengthening.	Other: Myofunctional and respiratory training program; The patients will receive exercises included in a myofunctional approach and a respiratory training focused on inspiratory and expiratory muscles using a device.
Active Comparator: Range of motion and stimulation exercises; Standard treatment focused mainly on range of motion, such as opening and closing the mouth and stimulation exercises	Other: Range of motion and thermal and mechanical stimulation exercising; The patients will receive the standard treatment of speech and language therapy including range of motion exercises (open and close the mouth) and thermal and mechanical stimulation in the orofacial region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume during monologue	The volumen during a monologue of basic activities of daily living assessed in decibels.	Baseline, 6 weeks
Frequency during monologue	The frequency during a monologue of basic activities of daily living expressed in hertz.	Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumen during sustained phonation of /s/ sound	The decibels during the maximum sustained phonation of s.	Baseline, 6 weeks
Communication effectiveness Index	This is a questionnaire with the scores ranging from 0 to 100, with lower scores meaning more difficulties associated to effectiveness in communication.	Baseline, 6 weeks
Frequency during sustained phonation of /s/ sound	The Hertzs during the maximum sustained phonation of s.	Baseline, 6 weeks
Volumen during sustained phonation of /a/ sound	The decibels during the maximum sustained phonation of a.	Baseline, 6 weeks
Frequency during sustained phonation of /a/ sound	The Hertzs during the maximum sustained phonation of a	Baseline, 6 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Irene Cabrera Martos, Ugr

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DF002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No