Myofunctional and Respiratory Intervention on Phonation in Stroke

NCT06322368 | Recruiting

• 1 other identifier: DF002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Volumen during sustained phonation of /s/ sound

  Baseline, 6 weeks

• Communication effectiveness Index

  Baseline, 6 weeks

• Frequency during sustained phonation of /s/ sound

  Baseline, 6 weeks

• Volumen during sustained phonation of /a/ sound

  Baseline, 6 weeks

• Frequency during sustained phonation of /a/ sound

  Baseline, 6 weeks

Study Arms (2)

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.

Other: Myofunctional and respiratory training program

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

Other: Range of motion and thermal and mechanical stimulation exercising

Interventions

Myofunctional and respiratory training program OTHER

The patients will receive exercises included in a myofunctional approach and a respiratory training focused on inspiratory and expiratory muscles using a device.

Myofunctional and respiratory training

Range of motion and thermal and mechanical stimulation exercising OTHER

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.

Range of motion and stimulation exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences

Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Irene Cabrera Martos

  UGR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cabrera Martos

CONTACT

958248763; irenecm@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor titular de Universidad

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 21, 2024
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)