SpeechATAX: Intensive home based biofeedback driven speech treatment for hereditary ataxia

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000519257
• Date of registration: 09/04/2018
• Prospective Registration: Yes
• Primary sponsor: The University of Melbourne
• Public title: SpeechATAX: Intensive home based biofeedback driven speech treatment for hereditary ataxia
• Scientific title: SpeechATAX: A 2-arm, examiner-blinded, wait-list control group randomized controlled trial of intensive home based biofeedback driven speech rehabilitation in hereditary ataxia
• Date of first enrolment: 01/06/2018
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000519257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, France, Germany, New Zealand

Contacts

• Name: Miss Hannah Reece

• Name: A/Prof Adam Vogel

Key inclusion & exclusion criteria

Inclusion criteria: Genetically confirmed diagnosis of hereditary ataxia including diagnosis of spinocerebellar ataxia (any type) or Friedreich ataxia.


Exclusion criteria: No genetically confirmed diagnosis of spinocerebellar ataxia (any type) or genetically confirmed diagnosis of Friedreich ataxia. People with other progressive neurological disorders including Parkinson's disease, multiple sclerosis and Huntington's disease will not be included in this study.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Neurodegenerative diseases

Physical Medicine / Rehabilitation - Speech therapy

Dysarthria;Friedreich ataxia;Spinocerebellar ataxia;
Dysarthria
Friedreich ataxia
Spinocerebellar ataxia

Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

Intervention(s)

Treatment will involve a behavioural intervention designed to improve speech intelligibility and quality (SpeechAtax computer software).

Materials: Patients will be provided with a tablet with treatment software installed, head mounted USB microphone and treatment manual. The treatment manual includes comprehensive instructions for the exercises to complete for each of the 20 days of therapy.

Procedures: The program is designed specifically to target improving overall speech intelligibility as well as vocal control and prosody. It is based on principles of motor learning and neuroplasticity relating to practice conditions and bio-feedback.

The program consists of three stages:

Phase I: Teaching and Establishment of treatment components
The clinician introduces the goals and content of the therapy. Patients learn the skills needed to undertake the program and implementation of the exercises. Using the computer program will be reviewed and practiced together on the first visit.

Phase II: Instatement and Rehabilitation
Therapy is completed in the home by the patient over 20 sessions within one month. Each session consists of exercises aiming to improve vocal quality and control, articulation, prosody and intelligibility. Self-evaluation skills are refined by the use of visual, aural and performance feedback and personalised problem-solving strategies. Clinicians monitor patient progress and provide support during this stage through weekly skype or phone calls.

On each treatment day, the patient is required to complete seven exercises outlined in the SpeechAtax software and treatment manual:
i) Long vowel x 10 repetitions
ii) Loudness exercise: crescendo/decrescendo x 10 repetitions
iii) Pitch glide x 10 repetitions
iv) Emphasis/Stress: Short phrases with target word designed to improve prosody x 15
v) Articulation: words and short phrases to practice over-enunciation
vi) Reading task
vii) Transfe

Primary Outcome(s)

Intelligibility: To be rated via expert perceptual judgement (blinded assessors) of the first 30 seconds from the monologue using direct magnitude estimation (DME). [Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment [primary timepoint], and again 4 weeks post completion of treatment for both groups. ]

Secondary Outcome(s)

Communication partner perception (Communicative Effectiveness Survey, CES) The CES is a standardised survey describing domains of communication beyond intelligibility. Disorder-specific patient-reported outcomes will address issues unique to the condition being studied.[Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Paired comparison ratings of conversation by naïve listeners. Listeners are asked to decide which of two audio-recorded samples (pre- and post-treatment, played in random order) is clearer. Informal objective rating scale will be used. [Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Carer survey. An informal survey of carer time will provide data on healthcare-related costs. This survey has been designed specifically for this study. [Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Oral motor function derived from Frenchay Dysarthria Profile - 2 which examines muscles and functions relevant for speech including lips, tongue, breathing, palate.[Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Overall disease severity. Scale for the assessment and rating of ataxia (SARA) score[Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Speech-related quality of life (Dysarthria Impact Profile, DIP). The DIP is a standardised survey on the psychosocial impact of acquired dysarthria from the speaker’s perspective.[Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Health utility score (SF-36). The SF-36 will inform economic quality of life outcomes[Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Objective measures of speech, including acoustic measures of timing (eg. pause length in reading and monologue tasks), vocal control (eg. fundamental frequency and loudness variation from vowel and monologue), and vocal quality (eg. dysphonia measures derived from sustained vowel). This is a composite secondary outcome. [Baseline assessment (week 1), post baseline assessment at week 4 (and 8 weeks for group B). Then assessment immediately post treatment, and again 4 weeks post completion of treatment for both groups. ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Australian Government, Department of Health

Secondary Sponsor(s)

Friedreich Ataxia Research Association (FARA)

Royal Brisbane and Women's Hospital

Universitatsklinikum Tuebingen

Ethics review

Status: Approved
Approval date:
Contact:

Medical Ethics Board, University Hospital Tübingen, Germany (Az. 003/2015BO2

Status: Approved
Approval date:
Contact:

The University of Melbourne Psychology Health and Applied Sciences Human Ethics Committee