ANZCTR - Registration

Registration number

ACTRN12612000968875

Ethics application status

Approved

Date submitted

27/08/2012

Date registered

10/09/2012

Date last updated

10/09/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Using CLEAR SPEECH to improve speech disorders following stroke or traumatic brain injury

Scientific title

In adults with non-progressive dysarthria resulting from stroke or traumatic brain injury, does CLEAR SPEECH compared to traditional speech therapy techniques result in greater improvements in speech intelligibility

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Non-progressive dysarthria

Stroke

Traumatic brain injury

Condition category

Condition code

Physical Medicine / Rehabilitation

Speech therapy

Stroke

Ischaemic

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

CLEAR SPEECH program: Participants will first undergo two 1-hour ‘pre-practice’ treatment sessions aimed at instating CLEAR SPEECH production. During this phase participants will watch videos of people demonstrating ‘clear speech’ which they will be required to imitate. The clinician will then provide specific feedback on the participants speaking technique in order to shape their speech production into CLEAR SPEECH.

Following the pre-practice phase participants will then move onto the intensive ‘practice’ phase of the treatment regime. This phase of the treatment program consists of 1-hour therapy sessions, 4 times a week, for a one month period. Daily home practice is also required and will be strictly monitored to ensure compliance. Therapy will involve practicing tasks such as producing functional phrases, reading short passages, and holding conversations in a CLEAR manner in order to increase the clarity and intelligibility of the individual’s speech. During treatment the clinician will provide general feedback on speech clarity, labelling speech attempts as either ‘clear’ or ‘unclear’. Modelling of CLEAR SPEECH will also be provided where necessary. In addition, the participant’s speech attempts will be recorded using a digital audio recorder. These speech samples will be played back to the participant intermittently to aid in the development of self-evaluation skills. Participants will rate the speech clarity of the recorded samples on a 10-point scale, with 1= very unclear speech and 10 = clear speech.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The results of the CLEAR SPEECH group will be compared with participants receiving traditional dysarthria therapy (TRAD).

TRAD: In addition to accessing current literature on traditional therapy techniques, management strategies employed with participants allocated to the traditional treatment group will be determined by conducting a focus group with practicing speech pathologists experienced in dysarthria management. The focus group will aim to establish (1) what clinicians perceive to be standard practice for treating non-progressive dysarthria and (2) typical exercise regimes including the number of repetitions normally used within a given activity and the number of activities presented in a session. Therapy is likely to involve different exercises including breathing exercises, oro-motor exercises designed to strengthen the muscles of the mouth and face, CPAP therapy, and speech drills designed to increase the accuracy of speech sound production. Traditional therapy will be delivered at the same intensity as the CLEAR SPEECH group with both groups receiving four 1 hour sessions per week for 4 weeks (total 16 hours).

Control group

Active

Outcomes

Primary outcome [1]

Vowel Space Area: Participants will be asked to read or repeat after the examiner a series of words in their normal voice five times. Words to be produced will be in the form of 'bVd' (e.g. 'bead', 'booed', 'bad', and 'bard'). Vowel sounds assessed will be the vowel sounds representing the four corners of the Australian vowel quadrilateral.The formant frequencies (i.e. F1 & F2) of these vowels will be recorded using a Korg MR-1 audio recorder via a headset microphone and then analysed using PRAAT software. These formants are related to the three-dimensional shape of an individual's vocal tract, providing information relating to tongue height (i.e., F1) and anterior/posterior placement (i.e., F2). Values of formants will be averaged across the two assessment sessions within each assessment phase, and then used to compute the vowel space area.

Timepoint [1]

This assessment will be conducted across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU). Each assessment phase will be comprised of two assessment sessions, performed 2 days apart, to ensure the accuracy of measurements taken as well as to account for the effects of day-to-day variability

Primary outcome [2]

Paired Comparison rating of intelligibility: To evaluate changes in a participant's ability to be understood by everyday communication partners, paired comparison ratings will be performed. Comparisons will be based on speech samples from readings of 'The Rainbow Passage' (Fairbanks, 1960) and a conversational speech sample in the participant's normal speaking voice. These speech samples will then be randomly presented in several different combinations including: (1) pre-treatment - post-treatment, (2) pre-treatment - FU, (3) post-treatment- pre-treatment, and (4) FU - pre-treatment. Naive listeners will listen to the pairs of speech samples to determine if the treatment has had a positive impact on the participant's ability to be understood by everyday listeners. Listeners will be required to determine which speech sample of each pair is easier to understand via speakers in a quiet room.

Timepoint [2]

This assessment will be conducted across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU). Each assessment phase will be comprised of two assessment sessions, performed 2 days apart, to ensure the accuracy of measurements taken as well as to account for the effects of day-to-day variability

Secondary outcome [1]

Assessment of Intelligibility of Dysarthric Speech (ASSIDS): Speech intelligibility (how easily a person is understood) will be evaluated using the ASSIDS (Yorkston & Beukelman, 1984). Participants will be required to either read or repeat after the examiner 50 single words and 22 sentences which will be randomly chosen from lists of words and sentences provided in the ASSIDS manual. Recordings of these words and sentences will be randomly presented to two independent and blinded speech therapists who will transcribe and record the length of each utterance. This information will be used to calculate the mean value for percentage word intelligibility, percentage sentence intelligibility, words per minute, and communication efficiency ratio for each of the three assessment phases.

Timepoint [1]

This assessment will be conducted across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU). Each assessment phase will be comprised of two assessment sessions, performed 2 days apart, to ensure the accuracy of measurements taken as well as to account for the effects of day-to-day variability

Secondary outcome [2]

Evaluation of perceptual speech features: The perceptual speech aspects of intelligibility, loudness, articulatory precision, breathiness, roughness, inappropriate stress, breath support, general rate, and pitch will be assessed in each participants speech using direct magnitude estimation (DME) (Weismer & Laures, 2002). The speech sample used for the ratings will be a reading of 'The Grandfather Passage' (Darley, Aronson, & Brown, 1975) in the participant's normal speaking voice. The middle three sentences of the passage will be used for analysis. Trained listeners will then have to assign each perceptual speech aspect a rating based in comparison to a standard speech sample. These ratings will be used in the statistical analysis.

Timepoint [2]

This assessment will be conducted across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU). Each assessment phase will be comprised of two assessment sessions, performed 2 days apart, to ensure the accuracy of measurements taken as well as to account for the effects of day-to-day variability

Secondary outcome [3]

Participants will be required to either read or repeat after the examiner a series of words and sentences as well as provide a conversational speech sample in their normal speaking voice. Speech files will be recorded using a Korg MR-1 audio recorder via a head set microphone and analysed using PRAAT computer software in order to determine the pitch, speech rate, pause duration and frequency, vowel duration and consonant-to-vowel ratio of each participants speech.

Timepoint [3]

This assessment will be conducted across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU). Each assessment phase will be comprised of two assessment sessions, performed 2 days apart, to ensure the accuracy of measurements taken as well as to account for the effects of day-to-day variability

Secondary outcome [4]

Dysarthria Impact Profile (DIP): Participants will be required to complete the DIP (Walshe, Peach, & Miller, 2009), a questionnaire designed to investigate the psychosocial impact of dysarthria on the participant. The DIP comprises five sections with a total of 48 statements. Participants will be required to rate each statement on a five-point scale from 'Strongly agree' to 'Strongly disagree'. These responses are given a weighted score, i.e. positively worded statements to which the respondent 'strongly agrees' receive a score of 5 and 'strongly disagree' statements receive a score of 1. In negatively worded statements, the reverse is true with 'strongly disagree' statements receiving a score of 5. These scores will be used to calculate a Total Impact Score.

Timepoint [4]

This assessment will be conducted once across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU).

Secondary outcome [5]

Communication Partner questionnaire: The primary communication partner of each participant will be asked to rate five different aspects of the participant's everyday communication abilities on a scale of 1 to 7. A rating of 7 was indicative of a very good ability, while a rating of 1 indicated that the client demonstrates a poor ability for the chosen item of communication. Questions included: 1) How easy is it to understand the speaker? 2) How often do you ask the speaker to repeat themselves? 3) How often does the speaker initiate conversation with you? 4) How often does the speaker initiate conversation with an unfamiliar person? And 5) Overall, how would you rate the speaker's speech and voice? Communication partners will also be provided with space to allow for additional comments to be made regarding the participant's communication and/or the treatment.

Timepoint [5]

This assessment will be conducted once across three assessment phases; (1) prior to treatment, (2) immediately post treatment, and (3) 1 to 3 months post treatment depending on the participants availability (FU).

Eligibility

Key inclusion criteria

To be eligible to participate in the study, participants will be required to be English speaking, have mild to severe non-progressive dysarthria as diagnosed by a speech pathologist, be 6 months post neurological incident, and have a cognitive status that is adequate to participate in assessment tasks. Prior to commencing the study participants will also undergo stimulability testing to assess whether they have the potential for improvements in speech clarity. Only potential participants who are able to demonstrate improvements for speech clarity will be included in the study.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Potential participants will be excluded if, in addition to their dysarthria, they present with a co-morbid condition that may negatively impact on their ability to complete speech therapy. Such conditions include significant aphasia, hearing or vision loss, dementia, apraxia of speech, or post traumatic amnesia. Prior to inclusion in the study research personnel will screen all potential participants.

Study design

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

21/08/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

40

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Country [1]

Primary sponsor type

University

Name

The University of Queensland

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Overall this research aims to determine whether or not CLEAR SPEECH is a viable treatment option for patients with non-progressive dysarthria.  Specifically, this research project aims to:

1. Determine the efficacy of CLEAR SPEECH as a treatment for non-progressive dysarthria following stroke and TBI across a range of perceptual, acoustic and everyday communication outcome measures. 

2. To compare the effects of CLEAR SPEECH with the outcomes of traditional dysarthria therapy (TRAD) in individuals with non- progressive dysarthria. 

It is hypothesized that CLEAR SPEECH will result in short and long term improvements to perceptual and acoustic measures of speech function, and ratings of everyday communication in individuals with non-progressive dysarthria. Also, the degree of improvement in speech and communication parameters will be greater following CLEAR SPEECH compared to the effects achieved following TRAD.

Trial website

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Email

Contact person for public queries

Name

Stacie Park

Address

School of Health and Rehabilitation Sciences
Therapies Building
University of Queensland
St Lucia 4072

Country

Australia

Phone

+61 422 102 094

Email

[email protected]

Contact person for scientific queries

Name

Stacie Park

Address

School of Health and Rehabilitation Sciences
Therapies Building
University of Queensland
St Lucia 4072

Country

Australia

Phone

+61 422 102 094

Email

[email protected]

Trial Review

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