Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000737639p
Ethics application status
Submitted, not yet approved
Date submitted
8/02/2023
Date registered
7/07/2023
Date last updated
7/07/2023
Date data sharing statement initially provided
7/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Group therapy for dysarthria following stroke and brain injury compared to individual therapy
Scientific title
Comparing the effect of group therapy compared to individual therapy on communication for adults with non-progressive dysarthria: A pilot randomised controlled trial
Secondary ID [1] 308280 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysarthria 328059 0
stroke 328060 0
traumatic brain injury 328061 0
Condition category
Condition code
Physical Medicine / Rehabilitation 325121 325121 0 0
Speech therapy
Neurological 325122 325122 0 0
Other neurological disorders
Stroke 326020 326020 0 0
Haemorrhagic
Stroke 326021 326021 0 0
Ischaemic
Injuries and Accidents 326022 326022 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pre-assessment will include outcome measures listed (i.e., Frenchay Dysarthria Assessment, Assessment of Intelligibility in Dysarthric speech (ASSIDS), self-report questionnaires) and be conducted face to face, one on one, by a speech pathologist not involved in the participant's treatment in a quiet room, with consistent audio recording procedures including using a mp3 audio recorder and condenser headset microphone positioned at a 5cm mouth-to-microphone distance.

Following this, the treating Speech Pathologist (SP) will use pre-assessment results to inform identification of an externally focussed, tailored clear speech strategy for each participant targeting speech intelligibility. Each participant will then undergo two one-on-one sessions scheduled with their treating SP involving instatement of the clear speech strategies, using principles of motor learning as per Park et al’s ‘Be clear’ treatment. These will aim to be on two separate days (across two consecutive days) for approximately 50min in duration and take place approximately 1-2 days prior to commencing either individual or group therapy participants.

Group therapy:
Participants allocated to receive group therapy will receive 12 sessions of group therapy delivered for 50 min, 4 days/week for 3 weeks by an SP based on the “Be clear” dysarthria treatment protocol, consistent with principles of motor learning and neuroplasticity principles of intensity, repetition, specificity and saliency. Group therapy will consist of a maximum of four participants with dysarthria and may also include other patients not part of the research study (i.e., outpatients). Sessions will take place in a group room face to face in the Speech Pathology department of the Gold Coast University Hospital. Tasks each group session will include:
- reminder of clear speech strategies (i.e., written on white board)
- practicing clear speech strategies in spoken functional phrases (developed collaboratively for each individual), service requests and functional speech tasks (alternating between reading, picture description and conversational speech tasks with self-ratings). Tasks are practiced in a combination of alternating turns, group speaking and in pairs with feedback provided by other pair members and SP in accordance with principles of motor learning.
-Homework tasks to transfer practice outside the therapy environment will also be provided (e.g., making phone calls).


- Treatment adherence:
Up to 10% of sessions (of both group and individual therapy) will be randomly video-recorded and reviewed according to a prescribed data coding tool to measure adherence to key elements of the programme.

-Participant attendance & recruitment:
The treating SP will record attendance across both models.

As active participation is required for treatment, participant and SP blinding to treatment allocation is not possible. SPs undertaking everyday communication and speech intelligibility measures however will be blinded to treatment allocation and the assessment time-point.
Intervention code [1] 324733 0
Rehabilitation
Comparator / control treatment
The control group will include treatment provided by a speech pathologist individually to the participant. Approximately 1-2 days after completing the instatement phase, individual treatment will begin. Treatment will use the same “clear speech” strategies identified by the SP in the instatement phase practised in functional phrases, service requests, and connected speech tasks with training of self-monitoring skills to promote self-efficacy and self-management also incorporated, Treatment will be offered at the same frequency (i.e., for 50 min, 4 days/week for 3 weeks) and delivered by a speech pathologist face to face in a speech pathology treatment room at Gold Coast University Hospital.
A total of 14 individual sessions will be provided (i.e., two one on one sessions during the instatement phase and 12 one one one sessions as part of the comparator intervention).
Control group
Active

Outcomes
Primary outcome [1] 333782 0
Everyday communication rating using the Activity scale of the Australian Therapy Outcome Measure (AusTOMs)
Timepoint [1] 333782 0
2 x baseline sessions (completed pre-commencement on 2 consecutive days prior to treatment)
2 x post assessment sessions (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [1] 418282 0
Frenchay Dysarthria Assessment
Timepoint [1] 418282 0
1x Baseline session (completed prior to treatment)
1 x post assessment session (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [2] 418283 0
The Assessment of Intelligibility of Dysarthric Speech
Timepoint [2] 418283 0
2 x baseline sessions (completed pre-commencement on 2 consecutive days prior to treatment)
2 x post assessment sessions (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [3] 418284 0
Paired comparison intelligibility rating
Timepoint [3] 418284 0
1x Baseline session (completed prior to treatment)
1 x post assessment session (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [4] 418285 0
Communication Effective Index- Modified
Timepoint [4] 418285 0
1x Baseline session (completed prior to treatment)
1 x post assessment session (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [5] 418286 0
Dysarthria Impact Profile
Timepoint [5] 418286 0
1x Baseline session (completed prior to treatment)
1 x post assessment session (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [6] 418287 0
EuroQol-5D-5L
Timepoint [6] 418287 0
1x Baseline session (completed prior to treatment)
1 x post assessment session (i.e., within approximately 2-3 days of completing the final therapy session for 2 consecutive day)
Secondary outcome [7] 418288 0
Patient and carer satisfaction questionnaire designed specifically for the study.
Timepoint [7] 418288 0
Participant and carer questionnaire- upon completion of final therapy session
Secondary outcome [8] 418289 0
Acceptability assessed through a focus group of participants and carers
Timepoint [8] 418289 0
Upon completion of data collection (i.e., all treatment sessions completed).
Secondary outcome [9] 418290 0
Health resource utilisation

Health resources used including consumables and staff labour directly (e.g., providing therapy) or indirectly (e.g., planning sessions, documentation) attributable to the study treatments for each patient will also be collected by treating speech pathologists completing a daily log inputted into and a password protected spreadsheet
Timepoint [9] 418290 0
Collected throughout treatment
Secondary outcome [10] 418291 0
Treatment adherence assessed by up to 10% of sessions will be randomly video-recorded and reviewed according to a prescribed data coding tool to measure adherence to key elements of the programme.
Timepoint [10] 418291 0
Throughout treatment
Secondary outcome [11] 418292 0
Participant attendance across both group and individual therapy collected through patient attendance logs competed by the treating SP.
Timepoint [11] 418292 0
Collected throughout trial
Secondary outcome [12] 418772 0
Participant recruitment rates assessed through recruitment logs and reasons for non-consent will be kept.
Timepoint [12] 418772 0
Throughout trial
Secondary outcome [13] 422695 0
Staff satisfaction through questionnaire designed specifically for the study
Timepoint [13] 422695 0
Upon completion of data collection (i.e., all treatment sessions completed).
Secondary outcome [14] 422696 0
Acceptability assessed through a focus group of staff
Timepoint [14] 422696 0
At the end of trial completion (once all therapy sessions are complete)

Eligibility
Key inclusion criteria
There are three participant groups:

1)Dysarthria participants:
Adult inpatients with dysarthria from stroke or acquired brain injury (as diagnosed by a speech pathologist [SP]).

2)Caregiver participants:
Caregivers of participants who have consented to receive treatment in the study and who are proficient in English will be invited to complete two questionnaires.

3) Speech Pathologists:
Approximately 6-8 SPs employed by GCH providing or assessment in the study at the time of the research will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Dysarthria participants:
Significant aphasia or apraxia of speech that would preclude participation in dysarthria therapy, as judged by the treating SP based on completion of routine language screening. As a guide, participants who have greater than a mild aphasia (i.e., <76 on the Western Aphasia Battery bedside screener) will be excluded.
Diagnosis of dementia, currently in post-traumatic amnesia as documented in the patient’s medical record.
Cognitive impairment impacting on their ability to participate in dysarthria therapy as judged by the treating multi-disciplinary team. As a guide, scores <22 on the Montreal Cognitive Assessment (MOCA) indicating impairments greater than a mild cognitive impairment will be excluded.
Significant hearing loss (i.e., profound deafness) or perceptual impairment as documented in the medical record that would preclude the participant from interacting in dysarthria therapy.
Very severe dysarthria or anarthria (total loss of speech) which would preclude ability to participate in group-based therapy based on clinical judgement of a SP. As per definition of severe dysarthria from the AUsTOMs, this may include extremely restricted range of phoneme production (e.g., only one sound class such as vowels or extremely limited strength, range and/or rate of oral movements or control.
Not proficient in English prior to onset of dysarthria.

2)Caregiver participants:
Caregivers <18 years or who self-report any health issue which would prevent them from completing a questionnaire will be excluded.

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)
The study statistician, who is blinded to participant identification, will undertake the randomization and provide treatment allocation to a SP researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An adaptive randomisation method will be used which enables groups to be filled randomly but with greatest efficiency while also ensuring a balanced design. This method was designed specifically for this study using the random number generator function of Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Being a pilot study, descriptive statistics (means, 95% CIs) will be reported across outcome measures including health resource utilisation and cost measures. Qualitative content analysis will be used for the free-form questionnaire responses and transcribed focus group interviews. This will involve two members of the research team grouping related meaning units into categories and subcategories in NVivo. Any coding discrepancies will be reviewed by a third member of the research team.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23954 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 39444 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 312527 0
Hospital
Name [1] 312527 0
Gold Coast University Hospital
Country [1] 312527 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard, Southport Qld 4215
Country
Australia
Secondary sponsor category [1] 314853 0
None
Name [1] 314853 0
None
Address [1] 314853 0
N/A
Country [1] 314853 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311862 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 311862 0
Ethics committee country [1] 311862 0
Australia
Date submitted for ethics approval [1] 311862 0
01/11/2022
Approval date [1] 311862 0
Ethics approval number [1] 311862 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122634 0
Dr Rachel Wenke
Address 122634 0
Gold Coast University Hospital
Allied Health Services
D block Ground Floor
1 Hospital boulevard, Southport, Qld 4215
Country 122634 0
Australia
Phone 122634 0
+61403808931
Fax 122634 0
Email 122634 0
[email protected]
Contact person for public queries
Name 122635 0
Rachel Wenke
Address 122635 0
Gold Coast University Hospital
Allied Health Services
D block Ground Floor
1 Hospital boulevard, Southport, Qld 4215
Country 122635 0
Australia
Phone 122635 0
+61403808931
Fax 122635 0
Email 122635 0
[email protected]
Contact person for scientific queries
Name 122636 0
Rachel Wenke
Address 122636 0
Gold Coast University Hospital
Allied Health Services
D block Ground Floor
1 Hospital boulevard, Southport, Qld 4215
Country 122636 0
Australia
Phone 122636 0
+61403808931
Fax 122636 0
Email 122636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data will be available upon request of individual participant assessment results
When will data be available (start and end dates)?
At the end of the trial, likely to be around late 2024, which will be available for 5 years after the end of the trial.
Available to whom?
To researchers who want to synthesis data for systematic reviews or studies that pool data to answer specific research questions.
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Upon request from PI via email [email protected]


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.