University of Wisconsin-Madison Waisman Center
Madison, Wisconsin, 53705, United States
Location status: Recruiting
NCT Number: NCT07173049
The goal of this clinical trial is to learn if speech supplementation can improve speech intelligibility in children ages 7 to 17 years with cerebral palsy. The main questions it aims to answer are:
* To what extent can speech supplementation improve intelligibility in children with CP compared with habitual speech produced without speech supplementation? * How much intelligibility change is necessary for meaningful improvement when children use speech supplementation strategies?
Participants will:
* complete speech and language assessments * complete a speech pre-test using habitual speech * learn a speech supplementation strategy with training from a speech-language pathologist * complete a speech post-test using the speech supplementation strategy * complete a speech repetition task where specific words are emphasized (emphatic stress) * use the previously learned speech supplementation strategy + emphasis on specific words while producing a set of sentences
Interested in participating?
Request Info7 year–17 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Location status: Recruiting
This study uses a pre-/post- test design to test the effects of a one-session intervention to improve speech intelligibility in 100 children with cerebral palsy and dysarthria. The intervention involves the augmentative and alternative communication (AAC) strategy known as speech supplementation. Specifically, children will learn how to simultaneously speak and point to the first letter of each word on a communication board, or to speak and point to a topical picture on a communication board. The strategy serves to provide listeners with context cues for spoken words, and it also serves to impact temporo-acoustic features of speech by reducing rate of speech and making word boundaries clear.
In this study, children will first participate in a set of baseline assessment measures, which will include the production of a corpus of 60 sentences (referred to as "habitual speech"). Then, children will learn to use the speech supplementation strategy through one-on-one clinician modeling, teaching, and practice. When children have mastered the strategy on a set of practice sentences, they will complete a post-test in which they produce the same set of elicited sentences a second time using speech supplementation.
Pre-test and post-test speech samples will then be played to two groups of listeners. One group will orthographically transcribe the words produced by children in both conditions (habitual and supplemented). Listener transcriptions in each condition will be scored as correct or incorrect based on whether they matched the intended word. Average percent of words identified correctly will be obtained from 2 listener for each child and each speaking condition as measures of speech intelligibility. The difference between habitual speech (pre-test) and supplemented speech (post-test) will be examined to quantify the effects of the speech supplementation on intelligibility.
The second set of listeners will hear the same speech samples as the first set (habitual speech and supplemented speech), but they will make ratings of whether one of the conditions seems more understandable than the other, and if so, they will rate how much better using a 7-point Likert scale.
These two sets of data from listeners will enable us to measure the minimum detectable difference in speech intelligibility and then the minimal clinically important difference based on listener ratings. Together these measures will enable us to determine how much change in intelligibility is necessary in order for clinically meaningful improvement.
The hypotheses are as follows:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The speech supplementation intervention involves learning to point to pictures, words, or letters on a communication board while simultaneously producing speech. Children will spend up to 30 minutes learning to use the strategy in one- on-one interaction with a speech therapist and demonstrate mastery by using the strategy successfully on a series of test stimuli.
Time frame: Before and after intervention within one session in a single day 1
Quantify the change in speech intelligibility associated with the use of speech supplementation strategies by having listeners orthographically transcribe speech samples. Intelligibility scores are percentage calculations of the number of words identified correctly by listeners, ranging from 0 to 100 percent. Higher percentages reflect greater intelligibility, or a better understanding of what the speaker said by naive listeners.
Time frame: Before and after intervention within one session in a single day 1
Listener ratings of their perception of the magnitude of change in intelligibility between pre- and post-test speaking conditions. Listeners will hear pre- and post-intervention speech samples and will indicate whether they can hear a differences and if so, how large the differences was using a 5-point likert rating scale. Higher values on the scale reflect larger perceived differences.
Time frame: Before and after intervention within one session in a single day 1
The duration of each utterance produced, inclusive of pauses, will be measured as the total time between the onset of the first word and the offset of the last word. The number of words in each utterance will be divided by the utterance duration, which will be averaged across all utterances pre- intervention and post- intervention at the child level.
Time frame: Before and after intervention within one session in a single day 1
Children will be divided into severity groups based on intelligibility scores obtained in pre-test condition. Three severity groups will be operationally defined: mild, moderate, and severe. The investigators will complete analyses of differences in treatment effects for children in the different severity groups to determine if the treatment is more effective for some severity groups than others.
Contact information is provided by the study sponsor or research team.
Heather Mabie
CONTACT
WISC Lab
CONTACT
University of Wisconsin, Madison
Other
Speech Supplementation Strategies for Improving Intelligibility in Children With Cerebral Palsy (CP)
Acronym: SPEAK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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