NCT07173049

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
39mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

April 15, 2026

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

September 8, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

Cerebral PalsySpeechIntelligibilitySpeech supplementationAugmentative and alternative communication

Outcome Measures

Primary Outcomes (1)

  • Change in speech intelligibility scores from pre- to post- intervention as measured by listener transcription of speech samples

    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.

    Before and after intervention within one session in a single day 1

Secondary Outcomes (1)

  • Perceived change in intelligibility from pre- to post-intervention as measured by listener ratings of the magnitude of difference between pre- and post- intervention speech samples.

    Before and after intervention within one session in a single day 1

Other Outcomes (1)

  • Exploratory: Change in speech rate from pre- to post- intervention as measured by difference in words per minute produced between pre- and post- intervention speech samples

    Before and after intervention within one session in a single day 1

Study Arms (1)

speech supplementation

EXPERIMENTAL

Children will complete a pre-test on their speech prior to learning speech supplementation strategy use, and will be taught to use speech supplementation through one-on-one teaching. They will then complete a post test on their speech while using speech supplementation.

Behavioral: AAC Speech supplementation

Interventions

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.

speech supplementation

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Medical diagnosis of cerebral palsy, or a similar, related condition that affects early motor development and presents as a chronic motor disability
  • Age between 7 and 17 years
  • Clinical dysarthria with speech intelligibility between 10-85 percent
  • Able to produce connected speech in English, with a minimum utterance length of 3 words
  • Able to use hands to point to items on a communication board
  • Cognitive/language skills that enable basic picture identification on a communication board
  • Pass pure tone hearing screening

You may not qualify if:

  • Vision impairment that precludes being able to see items on a communication board.
  • Not suitable for participation due to other reasons at the discretion of the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison Waisman Center

Madison, Wisconsin, 53705, United States

Location

Related Publications (6)

  • Sakash A, Mahr TJ, Natzke PEM, Hustad KC. Effects of Rate Manipulation on Intelligibility in Children With Cerebral Palsy. Am J Speech Lang Pathol. 2020 Feb 7;29(1):127-141. doi: 10.1044/2019_AJSLP-19-0047. Epub 2019 Dec 23.

    PMID: 31869242BACKGROUND
  • Korkalainen J, McCabe P, Smidt A, Morgan C. Motor Speech Interventions for Children With Cerebral Palsy: A Systematic Review. J Speech Lang Hear Res. 2023 Jan 12;66(1):110-125. doi: 10.1044/2022_JSLHR-22-00375. Epub 2023 Jan 9.

    PMID: 36623233BACKGROUND
  • Levy ES, Chang YM, Ancelle JA, McAuliffe MJ. Acoustic and Perceptual Consequences of Speech Cues for Children With Dysarthria. J Speech Lang Hear Res. 2017 Jun 22;60(6S):1766-1779. doi: 10.1044/2017_JSLHR-S-16-0274.

    PMID: 28655046BACKGROUND
  • Hustad KC, Lee J. Changes in speech production associated with alphabet supplementation. J Speech Lang Hear Res. 2008 Dec;51(6):1438-50. doi: 10.1044/1092-4388(2008/07-0185). Epub 2008 Jul 29.

    PMID: 18664687BACKGROUND
  • Hustad KC, Jones T, Dailey S. Implementing speech supplementation strategies: effects on intelligibility and speech rate of individuals with chronic severe dysarthria. J Speech Lang Hear Res. 2003 Apr;46(2):462-74.

    PMID: 14700386BACKGROUND
  • Stipancic KL, Yunusova Y, Berry JD, Green JR. Minimally Detectable Change and Minimal Clinically Important Difference of a Decline in Sentence Intelligibility and Speaking Rate for Individuals With Amyotrophic Lateral Sclerosis. J Speech Lang Hear Res. 2018 Nov 8;61(11):2757-2771. doi: 10.1044/2018_JSLHR-S-17-0366.

    PMID: 30383220BACKGROUND

MeSH Terms

Conditions

Cerebral PalsySpeech IntelligibilitySpeech

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVerbal BehaviorCommunicationBehavior

Study Officials

  • Katherine C Hustad, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

April 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 9 months after publication of primary outcomes, and ending 5 years after that date.
Access Criteria
Data will be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for the following types of analyses: Independent verification of study outcomes or to conduct subsequent clinical research. Proposals should be directed to kchustad@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

Locations