- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04520828
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
10
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: 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
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
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
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.
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)
June 28, 2012
Primary Completion (Actual)
July 16, 2015
Study Completion (Actual)
July 16, 2015
Study Registration Dates
First Submitted
August 14, 2020
First Submitted That Met QC Criteria
August 18, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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