Myofunctional and Respiratory Intervention on Phonation in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Myofunctional and respiratory training program; Other: Range of motion and thermal and mechanical stimulation exercising

• Registration Number: NCT06322368
• Lead Sponsor: Universidad de Granada

Brief Summary

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

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 Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-01-31
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-05-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myofunctional and respiratory training	Myofunctional and respiratory training program	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.
Range of motion and stimulation exercises	Range of motion and thermal and mechanical stimulation exercising	Standard treatment focused mainly on range of motion, such as opening and closing the mouth and stimulation exercises

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Granada, Spain