Myofunctional and Respiratory Intervention on Phonation in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322368
• Other study ID #: DF002
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Universidad de Granada
• Contact: Irene Cabrera Martos
• Phone: 958248763
• Email: irenecm[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume during monologue	The volumen during a monologue of basic activities of daily living assessed in decibels.	Baseline, 6 weeks
Primary	Frequency during monologue	The frequency during a monologue of basic activities of daily living expressed in hertz.	Baseline, 6 weeks
Secondary	Volumen during sustained phonation of /s/ sound	The decibels during the maximum sustained phonation of s.	Baseline, 6 weeks
Secondary	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
Secondary	Frequency during sustained phonation of /s/ sound	The Hertzs during the maximum sustained phonation of s.	Baseline, 6 weeks
Secondary	Volumen during sustained phonation of /a/ sound	The decibels during the maximum sustained phonation of a.	Baseline, 6 weeks
Secondary	Frequency during sustained phonation of /a/ sound	The Hertzs during the maximum sustained phonation of a	Baseline, 6 weeks