NCT04520828

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2015

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

August 14, 2020

Last Update Submit

August 18, 2020

Conditions

Keywords

acquired dysarthriacorrected seated posturemaximum phonation durationelectromyographic patterns

Outcome Measures

Primary Outcomes (1)

  • Change in maximum phonation duration

    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 Outcomes (4)

  • Change in trunk circumference in cm - Pre

    immediately before postural repositioning intervention

  • Change in manometry

    immediately before and after the 10 minute postural repositioning intervention

  • Change in EMG activation pattern

    immediately before and after the 10 minute postural repositioning intervention

  • Change in trunk circumference in cm - Post

    immediately after the 10 minute postural repositioning intervention

Other Outcomes (2)

  • Change in the level of satisfaction of participants with their performance assessed using a questionnaire

    immediately before and after the 10 minute postural repositioning intervention

  • Change in the participant's perceived effort to perform the task using a questionnaire

    immediately before and after the 10 minute postural repositioning intervention

Study Arms (1)

Postural repositioning

EXPERIMENTAL
Other: postural repositioning

Interventions

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.

Postural repositioning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and researcher

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 20, 2020

Study Start

June 28, 2012

Primary Completion

July 16, 2015

Study Completion

July 16, 2015

Last Updated

August 20, 2020

Record last verified: 2020-08