Acquired Dysarthria (Finding)NCT04520828
Immediate Effects of Postural Repositioning on Voice Production Tasks in Seated Individuals With Acquired Dysarthria:
A study testing postural repositioning in people with Acquired Dysarthria (Finding), run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal.
Trial summary
To determine the effectiveness of a single 10-min postural repositioning session on the maximum phonation duration in individuals with acquired dysarthria. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Dysarthria (Finding)
- What is being tested?
- postural repositioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2012to 16 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acquired Dysarthria (Finding)
- Being tested
- postural repositioning
- Keywords
- acquired dysarthria, corrected seated posture, maximum phonation duration, electromyographic patterns
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postural repositioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Postural repositioning | Experimental | Not described Receives: Other: postural repositioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum phonation duration
Production of the vowel 'a' as long as possible without running out of air
Measured: immediately before and after the 10 minute postural repositioning intervention
Secondary outcomes (4)
Change in trunk circumference in cm - Pre
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.
Measured: immediately before postural repositioning intervention
Change in manometry
time prolonged expiration
Measured: immediately before and after the 10 minute postural repositioning intervention
Change in EMG activation pattern
pattern of electromyographic activity of muscles in the neck and trunk
Measured: immediately before and after the 10 minute postural repositioning intervention
Change in trunk circumference in cm - Post
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.
Measured: immediately after the 10 minute postural repositioning intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start28 Jun 2012
- Primary completion16 Jul 2015
- Study completion16 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Dysarthria (Finding)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520828
- Sponsor's protocol ID
- PROJET CRIR-722-0312
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Postural Repositioning on Respiratory and Phonatory Tasks in Seated Individuals With Acquired Dysarthria: a Pilot Study
- ClinicalTrials.gov ID
- NCT04520828
- Acronym / sponsor ID
- PROJET CRIR-722-0312
- Conditions
- Acquired Dysarthria (Finding)
- Keywords
- acquired dysarthria, corrected seated posture, maximum phonation duration, electromyographic patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Study start
- 28 Jun 2012 (actual)
- Primary completion
- 16 Jul 2015 (actual)
- Study completion
- 16 Jul 2015 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effectiveness of a single 10-min postural repositioning session on the maximum phonation duration in individuals with acquired dysarthria.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot study
| Arm | Type | Receives |
|---|---|---|
| Postural repositioning | Experimental | Other: postural repositioning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postural repositioningThe 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. | Other | Postural repositioning |
Primary outcome
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
4 secondary outcomes
Change in trunk circumference in cm - Pre
Time frame: immediately before postural repositioning intervention
Change in manometry
Time frame: 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
Change in trunk circumference in cm - Post
Time frame: immediately after the 10 minute postural repositioning intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing postural repositioning in people with Acquired Dysarthria (Finding), run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum phonation duration (time frame: immediately before and after the 10 minute postural repositioning intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.