None listed
Conditions
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.
Interventions
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 d
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.
Sponsors
Centre of Research Excellence Cerebral Palsy (CRE CP)
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 18 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed