Trial Review

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Trial registered on ANZCTR


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] 281026 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-progressive dysarthria 287159 0
Stroke 287369 0
Traumatic brain injury 287370 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287480 287480 0 0
Speech therapy
Stroke 287701 287701 0 0
Ischaemic
Neurological 287703 287703 0 0
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] 285486 0
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] 287805 0
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] 287805 0
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] 287844 0
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] 287844 0
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] 298925 0
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] 298925 0
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] 298926 0
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] 298926 0
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] 298927 0
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] 298927 0
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] 298928 0
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] 298928 0
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] 298929 0
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] 298929 0
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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] 285812 0
Self funded/Unfunded
Name [1] 285812 0
Country [1] 285812 0
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
Queensland
4072
Country
Australia
Secondary sponsor category [1] 284686 0
None
Name [1] 284686 0
Address [1] 284686 0
Country [1] 284686 0

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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34575 0
Address 34575 0
Country 34575 0
Phone 34575 0
Fax 34575 0
Email 34575 0
Contact person for public queries
Name 17822 0
Stacie Park
Address 17822 0
School of Health and Rehabilitation Sciences
Therapies Building
University of Queensland
St Lucia 4072
Country 17822 0
Australia
Phone 17822 0
+61 422 102 094
Fax 17822 0
Email 17822 0
stacie.park@uqconnect.edu.au
Contact person for scientific queries
Name 8750 0
Stacie Park
Address 8750 0
School of Health and Rehabilitation Sciences
Therapies Building
University of Queensland
St Lucia 4072
Country 8750 0
Australia
Phone 8750 0
+61 422 102 094
Fax 8750 0
Email 8750 0
stacie.park@uqconnect.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.