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Trial registered on ANZCTR

Registration number

ACTRN12621000272897

Ethics application status

Approved

Date submitted

26/11/2020

Date registered

11/03/2021

Date last updated

11/03/2021

Date data sharing statement initially provided

11/03/2021

Date results provided

11/03/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Can an intensive voice treatment reduce drooling in children with cerebral palsy (CP)?

Scientific title

The effects of the Lee Silverman Voice Treatment LOUD (LSVT LOUD®) on drooling and related outcomes for children with Cerebral Palsy (CP): A single case experimental design (SCED) method

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1261-8856

Trial acronym

Linked study record

Health condition

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

Neurological

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A behavioural intervention, an intensive voice treatment called the Lee Silverman Voice Treatment LOUD approach (LSVT LOUD®), will be implemented with a group of children (7 yrs to 18 yrs) with cerebral palsy. This is a single case experimental design and therefore each individual serves as their own control within the experiment. Each participant will be randomly assigned to one of three treatment conditions:
1. Baseline period of 10 days, treatment commencing day 11.
2. Baseline period of 14 days, treatment commencing day 15.
3. Baseline period of 18 days, treatment commencing day 19.
The content of the treatment delivered to each participant is the same. The duration of participation therefore differs across these three different treatment conditions. The behavioural target of LSVT LOUD® is loudness (of voice).The treatment involves a number of voice exercises that are practised in isolation and in functional contexts four times a week for four weeks (16 treatment sessions in total over the course of one month). Each treatment sessions lasts for 60-minutes and can be offered either online or face-to-face. The interventionist is a speech pathologist who is certified in delivering LSVT LOUD®. The exercises are: 15 repetitions of 'ah', 'high- pitched ah' and 'low-pitched ah'; 5 repetitions x 10 functional phrases (using newer louder voice e.g. What is for dinner?); reading words, sentences, paragraphs using newer louder voice; and there is 10-15 minutes of homework daily. The homework entails 6 repetitions only of the core exercises (loud ah/ high-pitched ah/ low-pitched ah); and a carryover assignment in which the participant uses their newer louder voice in a functional way e.g. speaking with a grandparent on the phone. A self-monitoring strategy will be used by the interventionist to monitor treatment fidelity in which a daily LSVT LOUD®) treatment protocol sheet will be filled out. Each treatment session will be audio-video recorded for fidelity checks. Primary outcomes to be evaluated: drooling severity and impact of drooling. Secondary outcomes: swallowing and speech intelligibility.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Each participant serves as their own control. The individual's own performance is compared between the baseline, intervention and follow up phases.

Control group

Active

Outcomes

Primary outcome [1]

Drooling: 1) drooling severity (assessed using a validated outcome measure (Drooling Quotient, Van Hulst et al. 2011). No adverse effects from the intervention are known or anticipated.

Timepoint [1]

5 timepoints in each of the three phases (baseline, intervention and follow up) in keeping with a concurrent multiple baseline single case experimental design.
Baseline: day 1 pre-intervention, day 3 pre-intervention, day 6 pre-intervention, day 10 pre-intervention, day 14 pre-intervention.
Treatment: day 1 post-intervention, day 3 post-intervention, day 6 post-intervention, day 10 post-intervention, day 14 post-intervention.
Follow up (3 months after treatment phase ends): day 91 post-intervention, day 94 post-intervention, day 97 post-intervention, day 101 post-intervention, day 105 post-intervention.

Primary outcome [2]

2) impact of drooling (assessed using a validated parental completed questionnaire, the Drooling Impact Score (Reid et al, 2010).

Timepoint [2]

1 timepoint in each of the three phases (baseline, intervention and follow up).
Baseline: day 5 pre-intervention.
Treatment: day 8 post-intervention,
Follow up (3 months after treatment phase ends): day 98 post-intervention,

Secondary outcome [1]

Swallowing and feeding competency. The Dysphagia Disorders Survey (Sheppard, 2014) will be the validated scale used. This is an observational assessment of swallowing and feeding competency and will be completed by an independent trained assessor.

Timepoint [1]

3 sets of data will be taken in each of the baseline, treatment and follow up phases for each participant.
Baseline: day 1 pre-intervention, day 6 pre-intervention, day 14 pre-intervention.
Treatment: day 1 post-intervention, day 6 post-intervention, day 14 post-intervention.
Follow up (3 months after treatment phase ends): day 91 post-intervention, day 97 post-intervention, day 105 post-intervention.

Secondary outcome [2]

Speech intelligibility: The speech intelligibility sub-test of The Frenchay Dysarthria Assessment - 2nd edition (FDA-2) (Enderby, 2008), a validated assessment will be used.

Timepoint [2]

Eligibility

Key inclusion criteria

(i) confirmed diagnosis of CP;
(ii) aged 7 to 18 years;
(iii) intelligence Quotient (IQ) at or above the moderate range of disability;
(iv) evidence of frequent and severe drooling, with a stable presentation over the previous 3 months;
(v) level I to III communicators on the Communication Function Classification System (CFCS) (Hidecker et al., 2011);
(vi) verbal communicators who were able to produce an ‘ah’ vocalisation;
(vii) sufficient language skills to produce at least 3-4 worded utterances;
(viii) overall speech intelligibility greater than 30% and/or no greater than ‘moderate to severe’ dysarthria;
(ix) demonstrated high compliance with previous speech pathology interventions (as pre-determined by parent and/or speech pathologist);
(x) ability to maintain independent head control; and
(xi) hearing within normal limits/ no dual diagnosis of hearing impairment.

Minimum age

7 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria: (i) intellectual ability is greater than moderate-severe impairment (ii) presence of additional vocal pathology e.g. vocal nodules (iii) history of hoarse voice (iv) inconsistent drooling (periods when drooling is not present) (v) currently on medications that cause drooling e.g. clonazepam (vii) currently receiving other treatment for drooling e.g. block of oral sensory motor therapy.

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)

* Allocation was concealed using sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

3. simple randomisation procedure

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

The research design is a single experimental design (SCED) and therefore each participant serves as 'their own control' within the experiment. The type of SCED is a concurrent multiple baseline SCED in which there are three phases, baseline, intervention and follow up phase.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A systematic visual analysis (gold standard for data analysis when using SCEDs) will be completed, and supplemented with additional statistical techniques (Non overlap of all pairs(NAP)). Data on drooling (frequency and severity), swallowing and speech (word, sentence, conversational intelligibility) measures will be collected, entered into SPSS and plotted on graphic displays e.g., line graphs. A visual analysis includes the combined evaluation of level, trend, variability, immediacy of effect, data overlap in adjacent phases and consistency of data patterns in similar phases. Calculation of NAP will facilitate determining the size of treatment effect.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/11/2018

Date of last participant enrolment

Anticipated

Actual

23/01/2019

Date of last data collection

Anticipated

Actual

4/07/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment postcode(s) [1]

2060 - North Sydney

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

NHMRC Headquarters, 16 Marcus St, Canberra, ACT 2601.

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Centre of Research Excellence Cerebral Palsy (CRE CP)

Address

Murdoch Children's Research Institute, Royal Children's Hospital, Flemington Rd., Parkville, VIC 3052, Australia.

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Australian Catholic University

Address [1]

Australian Catholic University, Level 3, Tenison Woods House, 8-20 Napier St, North Sydney, NSW 2060.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University HREC

Ethics committee address [1]

Tenison Woods House, 8-20 Napier St, North Sydney, NSW 2060.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/07/2018

Approval date [1]

27/07/2018

Ethics approval number [1]

2018-142H

Ethics committee name [2]

Cerebral Palsy Alliance HREC

Ethics committee address [2]

187 Allambie Rd, Allambie Heights NSW 2100

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

02/07/2018

Approval date [2]

03/09/2020

Ethics approval number [2]

2018_08_03.

Summary

Brief summary

The focus of this research is on anterior drooling (spillage of saliva from the mouth that is clearly visible). Many children with cerebral palsy (CP)  experience difficulties controlling saliva. Potential reasons for this clinical feature of CP include: a reduction in swallowing ability; oral motor dysfunction, and hypersalivation; resulting in anterior loss of saliva from the mouth. Drooling can be a disabling condition for children with CP, adversely affecting physical health, emotional health, social interactions and self-esteem. These health impacts include skin maceration and skin breakdown; aspiration pneumonia and significant respiratory compromise; and social rejection from peers. Drooling has also been shown to increase the care needs of the child, putting families under increased stress. Thus, drooling has the potential reduce the quality of life of both children with CP and their families. A treatment approach that holds promise in improving swallowing and reducing swallowing in children with CP is the Lee Silverman Voice Treatment Approach (LSVT LOUD®), which is founded on neuroplasticity- and motor learning principles. This intensive voice treatment approach has level IV efficacy in improving speech, and has also resulted in significant improvement in swallowing in adults with Parkinson's Disease. Early phase I clinical outcome research has shown similar speech improvements in children with CP; and it is therefore reasonable to hypothesis that similar improvements in swallowing ability may occur, which in turn may facilitate a reduction in drooling.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michelle McInerney

Address

Australian Catholic University, Level 3, Tenison Woods House, 8-20 Napier St., North Sydney, NSW 2060.

Country

Australia

Phone

+61 2 94659118

Fax

[email protected]

Contact person for public queries

Name

Michelle McInerney

Address

Australian Catholic University, Level 3, Tenison Woods House, 8-20 Napier St., North Sydney, NSW 2060.

Country

Australia

Phone

+61 2 94659118

Fax

[email protected]

Contact person for scientific queries

Name

Michelle McInerney

Address

Australian Catholic University, Level 3, Tenison Woods House, 8-20 Napier St., North Sydney, NSW 2060.

Country

Australia

Phone

+61 2 94659118

Fax

[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?

Participant data underlying published data only (participants will be deidentified)

When will data be available (start and end dates)?

Immediately following publication, no end date.

Available to whom?

Case by case basis at the discretion of principal investigator/ lead researcher.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Access subject to approval by principal investigator/ lead researcher. Contact details of principal investigator: [email protected] or +61 2 9465 9118.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9878	Study protocol			[email protected]		381006-(Uploaded-29-01-2021-16-45-04)-Study-related document.pdf
9879	Ethical approval					381006-(Uploaded-29-01-2021-16-48-06)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically