Immediate Effects of Postural Repositioning on Voice Production Tasks in Seated Individuals With Acquired Dysarthria:

August 18, 2020 updated by: Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Immediate Effects of Postural Repositioning on Respiratory and Phonatory Tasks in Seated Individuals With Acquired Dysarthria: a Pilot Study

To determine the effectiveness of a single 10-min postural repositioning session on the maximum phonation duration in individuals with acquired dysarthria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The impact of dysarthria goes beyond communication. However, there have been no clear directives guiding clinical practice to date, and despite increasing evidence directing treatment, research remains limited and predominantly consists of case studies or case series. Despite the importance of postural control in voice production, the effects of postural alignment on speech production efficiency are either little investigated or not at all explored in the dysarthric population. This study determined the effectiveness of a single 10-min postural repositioning session on the maximum phonation duration (MPD) in individuals with acquired dysarthria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

**Participants with dysarthria Inclusion criteria

  • sustained a stroke or traumatic brain injury
  • diagnosed with dysarthria
  • impaired postural control following a neurological injury
  • are approaching the end of intensive rehabilitation or have finished intensive rehabilitation
  • express a desire to participate in the research
  • have the capacity to read.

Exclusion criteria

  • had any cognitive impairment that could prevent them from understanding directives or from expressing their opinion about their posture A neurologist clinically assessed the cognitive function of PWDs

    **Control participants

  • never diagnosed with dysarthria or any other voice impairment
  • no comorbidities.
  • no breathing deficits (e.g., asthma, chronic obstructive pulmonary disease)
  • no pathologies in the spinal cord, spinal column, or thoracic cage that could prevent them from freely moving their trunk
  • no neurological or cardiac problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Postural repositioning
Other: postural repositioning
The 10-min transdisciplinary intervention aimed (1) to facilitate and activate axial extension during standing and then during sitting; (2) to actively mobilize the trunk, cervical spine, and pelvic and shoulder girdles during standing and then during sitting; and (3) to adjust the seated position, as needed, with supports to ensure its maintenance throughout the experiment. Cushion, balls, boxes, or rolls were used to stabilize the final seated position.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in maximum phonation duration
Time Frame: immediately before and after the 10 minute postural repositioning intervention
Production of the vowel 'a' as long as possible without running out of air
immediately before and after the 10 minute postural repositioning intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in trunk circumference in cm - Pre
Time Frame: immediately before postural repositioning intervention
Measure of the circumference of the trunk taken at the level of the xyphoid process using a measuring tape when the participants achieves maximal inspiration and maximal expiration. The difference in circumference between maximal inspiration and maximal expiration is subsequently calculated.
immediately before postural repositioning intervention
Change in manometry
Time Frame: immediately before and after the 10 minute postural repositioning intervention
time prolonged expiration
immediately before and after the 10 minute postural repositioning intervention
Change in EMG activation pattern
Time Frame: immediately before and after the 10 minute postural repositioning intervention
pattern of electromyographic activity of muscles in the neck and trunk
immediately before and after the 10 minute postural repositioning intervention
Change in trunk circumference in cm - Post
Time Frame: immediately after the 10 minute postural repositioning intervention
Measure of the circumference of the trunk taken at the level of the xyphoid process using a measuring tape when the participants achieves maximal inspiration and maximal expiration. The difference in circumference between maximal inspiration and maximal expiration is subsequently calculated.
immediately after the 10 minute postural repositioning intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the level of satisfaction of participants with their performance assessed using a questionnaire
Time Frame: immediately before and after the 10 minute postural repositioning intervention
Following completion of voice tasks, the participants will be asked to grade their perceived level of performance in each posture (before and after the postural repositioning intervention) using the NER-21 scale. The participants are instructed to judge their vocal performance on the performance scale
immediately before and after the 10 minute postural repositioning intervention
Change in the participant's perceived effort to perform the task using a questionnaire
Time Frame: immediately before and after the 10 minute postural repositioning intervention
Following completion of voice tasks, the participants will be asked to grade their effort in each posture (before and after the postural repositioning intervention) using the NER-21 scale. The participants are instructed to indicate the effort required to speak on the effort scale
immediately before and after the 10 minute postural repositioning intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROJET CRIR-722-0312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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