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Clinical Trials/NCT06322368
NCT06322368UnknownNot Applicable

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

Universidad de Granada1 site in 1 country30 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Frequency during monologue

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Myofunctional and respiratory training

Experimental

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.

Intervention: Myofunctional and respiratory training program (Other)

Range of motion and stimulation exercises

Active Comparator

Standard treatment focused mainly on range of motion, such as opening and closing the mouth and stimulation exercises

Intervention: Range of motion and thermal and mechanical stimulation exercising (Other)

Outcomes

Primary Outcomes

Frequency during monologue

Time Frame: Baseline, 6 weeks

The frequency during a monologue of basic activities of daily living expressed in hertz.

Volume during monologue

Time Frame: Baseline, 6 weeks

The volumen during a monologue of basic activities of daily living assessed in decibels.

Secondary Outcomes

  • Volumen during sustained phonation of /s/ sound(Baseline, 6 weeks)
  • Communication effectiveness Index(Baseline, 6 weeks)
  • Volumen during sustained phonation of /a/ sound(Baseline, 6 weeks)
  • Frequency during sustained phonation of /s/ sound(Baseline, 6 weeks)
  • Frequency during sustained phonation of /a/ sound(Baseline, 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Irene Cabrera Martos

Profesor titular de Universidad

Universidad de Granada

Study Sites (1)

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