- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474691
staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback (staRt)
April 27, 2023 updated by: New York University
Previous research suggests that biofeedback can outperform traditional interventions for RSE, but no controlled studies have tested this hypothesis in the context of app-delivered biofeedback.
The objective of this aim is to use the staRt app to test our working hypothesis that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates biofeedback, compared to a non-biofeedback condition.
With a network of cooperating SLPs, this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of intervention using staRt.
Individual sessions will be randomly assigned to include or exclude the visual biofeedback display.
Randomization tests will be used to evaluate, for each individual, whether larger increments of change are associated with biofeedback and non-biofeedback sessions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10012
- New York University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 15 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Normal performance on a pure-tone hearing screening at 20 dB HL, a screening examination of oral-motor structure and function, and a test of receptive language.
Exclusion Criteria:
- History of major behavioral, neurological, or hearing impairment, per parent and/or SLP report.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visual-acoustic biofeedback
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In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum generated by the staRt app.
Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency.
They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.
Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display.
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Active Comparator: Traditional articulation treatment
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Traditional articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice.
Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available.
Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
Time Frame: F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks.
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From recordings of words containing /r/ produced during treatment sessions, the sound /r/ was flagged for measurement and the first three formants (F1, F2, F3) were extracted from the center of the /r/ interval.
The distance between the second and third formants (F3-F2) was used as the index of rhoticity.
F3-F2 is small in perceptually accurate /r/, larger values indicate lower accuracy.
Summary statistics report the mean and standard deviation of normalized F3-F2 distance for each treatment condition, pooled across participants and sessions.
A two-tailed paired-samples t-test (superiority criterion) was used to compare mean F3-F2 distance for each treatment condition across subjects.
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F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2018
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
June 15, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 17, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
April 27, 2023
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- staRt single-case
- R41DC016778 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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