Video Assisted Speech Technology to Enhance Motor Planning for Speech (VAST)

• ClinicalTrials.gov Identifier: NCT04764539
• Recruitment Status: Completed
• First Posted: February 21, 2021
• Results First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Sponsor: iTherapy, LLC
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Information provided by (Responsible Party): Lois Brady, iTherapy, LLC

Tracking Information

• First Submitted Date: February 9, 2021
• First Posted Date: February 21, 2021
• Results First Submitted Date: June 10, 2022
• Results First Posted Date: May 9, 2023
• Last Update Posted Date: May 9, 2023
• Actual Study Start Date: December 1, 2019
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2023)

• Change in Mean Length of Utterance (MLU) [ Time Frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment. ]
  Participants (aged 4 to 8 years) were given a pre- and post-test 15-minute language sample. MLU was calculated for tests and gain from pre-test to post-test was compared. NOTE: This measure is calculated based on a change in the number of morphemes per utterance during pre-test and post-test language samples. During a five-minute period, two licensed speech-language pathologists (SLP) observed a parent interacting and talking with their child. Parents Both SLPs transcribed the subjects' speech and calculated a mean length of utterance (MLU) for each subject. MLU was calculated by determining how many bound and free morphemes were included within every spoken utterance produced by a subject. The total number of morphemes produced within the 5-minute period were then divided by total number of utterances, which then produced the MLU for each subject. This procedure was use for determining MLU in both the pre- and post-testing procedures.
• Change in Percentage of Correctly Transcribed Words Using Automatic Speech Recognition [ Time Frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment. ]
  15-minute pre- and post-testing was performed using speech recognition software and transcribed by a licensed speech pathologist. Differences pre and post intervention were compared across group and within groups. NOTE: During our assessment, we used Google's native closed captioning function (a tool which uses machine learning to recognize and transcribe speech) and a third party app, Tactiq Pins, which allows users to keep a transcript of all speaker utterances during a call. We compared our video to the Tactiq Pin transcripts in order to measure any change in the amount of accurately transcribed spoken words between pre-test and post-test language samples. Specific transcription results for each group can be found in the data tables provided.
• Change in Articulation Accuracy [ Time Frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment. ]
  Change in % of correct phonemes in each attempted stimulus

Original Primary Outcome Measures (submitted: February 17, 2021)

• Increased mean length of utterance (MLU) [ Time Frame: 2 months ]
  Participants (aged 4 to 8 years) were given a pre and post test 15 minute language sample
• percentage of correctly transcribed words using automatic speech recognition [ Time Frame: 2 months ]
  15 minute pre and post testing was performed using speech recognition software and transcribed by a licensed speech pathologist
• change speech intelligibility [ Time Frame: 2 months ]
  Pre and Post test measures of % of speech intelligibility were given for each subject and transcribed by a licensed speech pathologist

Current Secondary Outcome Measures (submitted: April 16, 2023)

• Parent Perceptions of Communication Changes, Resulting From Study Participation. [ Time Frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment. ]
  Parent observations -- perceptions of changes in their children's motor-speech, behavioral, and social communication skills after having participated in the study Scale title: Net Positive Changes Score Maximum possible value: 18 Minimum possible value: -2 Higher score is better.
• Change in Type-Token Ratios [ Time Frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment. ]
  A type-token ratio measures the total number of unique words in a given segment of language.
• Increase in Response Rate to Treatment Stimuli [ Time Frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment. ]
  The change in response rate measures any significant differences in how often children responded to pre- and post-testing stimuli after having received treatment between the iPad Pro and VR goggles groups. A response is considered a verbal or non-verbal reaction (e.g., eye contact, gestures, vocalizations) to the stimuli presented during the therapy sessions. Higher response rates indicate better engagement and responsiveness to the treatment. The change in response rate is calculated as the value at the post-test time point minus the value at the pre-test time point, with positive numbers representing increases and negative numbers representing decreases in response rate.

Original Secondary Outcome Measures (submitted: February 17, 2021)

Generalization of skills [ Time Frame: 2 months post research study ]

Follow-up survey, at 2 months post research, with therapists who provide services once weekly

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Video Assisted Speech Technology to Enhance Motor Planning for Speech
• Official Title: Video Assisted Speech Technology to Enhance Functional Language Abilities in Individuals With Autism Spectrum Disorder
• Brief Summary: Nearly 3.5 million Americans are diagnosed with Autistic Spectrum Disorder (ASD), a communication disorder that causes skill limitations in the areas of language acquisition, sensory integration, and behavior. This lack of functional language ability limits conversation to its most basic parts, making daily tasks difficult for minimally to non-verbal individuals to achieve. iTherapy is developing the VAST platform, a personalized educational experience for students with ASD by creating a virtual reality-based video-modeling program to stimulate engagement and speech production practice, ultimately providing those with ASD an opportunity to enhance their quality of life by increasing their speech abilities which will enable them to build social networks and handle the events of daily life.

Detailed Description

Autism Spectrum Disorder (ASD) is a neurodevelopmental communication disorder resulting in functional language and behavioral delays affecting over 3.5 million Americans. These delays vary with the severity of symptoms that present in ASD but often result in limited speech and increased communication challenges. Alongside linguistic acquisition, oral motor coordination is a crucial part of speech production.

Current clinical techniques have shown varying degrees of efficacy in improving functional language proficiency. Most techniques follow a drill-like procedure, where the child is made to repeat various sounds and phrases until they are retained. However, such a process requires potentially over twenty therapy sessions to show improvement which may then only be focused on one aspect of speech. This significantly limits the linguistic and social skills a student will acquire. To improve the efficacy of these therapy sessions, new technology must be developed to provide the most effective educational experience.

Video-assisted speech technology (VAST) is a method of using a video of a close-up model of the mouth and speaking simultaneously with it. Rather than present the individual with a static photograph of the initial phoneme, the entire sequence of oral movements can be presented sequentially via video-recorded segments of the orofacial area producing connected speech, combining best practices, video modeling, and literacy with auditory cues to provide unprecedented support the development of vocabulary, word combinations and communication.

In this SBIR Phase I proposal, iTherapy will develop a personalized educational experience for students with ASD by creating a virtual reality (VR) based VAST program to stimulate engagement and speech production practice. VR offers several benefits as a therapy technique: overcoming sensory difficulties, more effectively generalizing information, employing visual learning, and providing individualized treatment. As a user moves through the stages of the program, they will be immersed in a proactive environment where they will engross themselves with continuous content.

Rather than present the individual with a static photograph of the initial phoneme, the entire sequence of oral movements can be presented sequentially via VR-modelled segments of the orofacial area producing connected speech, combining best practices, video modeling, music therapy, and literacy with auditory cues to provide unprecedented support the development of vocabulary, word combinations and communication. The innovation will be a video series of a realistic VR mouth which will require the use of an app on a tablet or a smartphone, VR goggles, and bone conduction headphones.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Six children with ASD, between the ages of 4 and 8, were recruited to participate in a 12-sessions-long study that utilized the Video-Assisted Speech Therapy (VAST) application. The participants were divided into two groups: one which received the VR-integrated prototype, and one that received a 2D application on a tablet. Each session was approximately 15 minutes long (+/- 5 minutes), occurring twice per week.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Autism Spectrum Disorder
• Apraxia of Speech

Intervention

Behavioral: Video Assisted Speech Therapy (VAST)

Six children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized the VR-integrated and the tablet-based VAST application. Three subjects received a 3D VR-integrated, bone conduction VAST prototype, while the remaining group of three received a tablet with a 2D version of the software. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).

Study Arms

• Active Comparator: Stimuli administered via 2D format on an iPad Pro
  Participants were given the Video-Assisted Speech Therapy (VAST) video-modeling stimuli in a 2D format (iPad Pro). Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized the tablet-based VAST application. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).
  Intervention: Behavioral: Video Assisted Speech Therapy (VAST)
• Active Comparator: Stimuli administered in 3D format via VR goggles and bone conduction headphones
  Participants were given the Video-Assisted Speech Therapy (VAST) video-modeling stimuli in a VR format paired with a custom 3D-printed VR headset. Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized a 3D VR-integrated VAST prototype with bone conduction audio. Sessions were held twice a week with each lasting approximately 15 min (i.e. +/- 5 minutes).
  Intervention: Behavioral: Video Assisted Speech Therapy (VAST)

Publications *

• Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1. Erratum In: MMWR Morb Mortal Wkly Rep. 2018 May 18;67(19):564. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1280.
• Autism Spectrum Disorder: Communication Problems in Children. (2018, August 30). Retrieved from https://www.nidcd.nih.gov/health/autism-spectrum-disorder-communication-problems-children
• Maas E, Robin DA, Austermann Hula SN, Freedman SE, Wulf G, Ballard KJ, Schmidt RA. Principles of motor learning in treatment of motor speech disorders. Am J Speech Lang Pathol. 2008 Aug;17(3):277-98. doi: 10.1044/1058-0360(2008/025).
• Bent S, Hendren RL. Complementary and alternative treatments for autism part 1: evidence-supported treatments. AMA J Ethics. 2015 Apr 1;17(4):369-74. doi: 10.1001/journalofethics.2015.17.4.sect1-1504. No abstract available.
• Lord, C., & Paul, R. (1997). Language and communication in autism. In D. Cohen & F. Volkmar (Eds.), Handbook of autism and pervasive developmental disorders (pp. 195-225). New York, NY: Wiley.
• Jang J, Matson JL, Williams LW, Tureck K, Goldin RL, Cervantes PE. Rates of comorbid symptoms in children with ASD, ADHD, and comorbid ASD and ADHD. Res Dev Disabil. 2013 Aug;34(8):2369-78. doi: 10.1016/j.ridd.2013.04.021. Epub 2013 May 22.
• Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
• Symptoms and Diagnosis of ADHD | CDC. (n.d.). Retrieved from https://www.cdc.gov/ncbddd/adhd/diagnosis.html.
• Sarah Parsons & Sue Cobb (2011) State-of-the-art of virtual reality technologies for children on the autism spectrum, European Journal of Special Needs Education, 26:3, 355-366, DOI: 10.1080/08856257.2011.593831
• Strickland DC, McAllister D, Coles CD, Osborne S. An Evolution of Virtual Reality Training Designs for Children With Autism and Fetal Alcohol Spectrum Disorders. Top Lang Disord. 2007 Jul 1;27(3):226-241. doi: 10.1097/01.tld.0000285357.95426.72.
• Evers, K., Noens, I., Steyaert, J., & Wagemans, J. (2011). Combining strengths and weaknesses in visual perception of children with an autism spectrum disorder: Perceptual matching of facial expressions. Research in Autism Spectrum Disorders,5(4), 1327-1342. doi:10.1016/j.rasd.2011.01.004
• Strickland D, Marcus LM, Mesibov GB, Hogan K. Brief report: two case studies using virtual reality as a learning tool for autistic children. J Autism Dev Disord. 1996 Dec;26(6):651-9. doi: 10.1007/BF02172354.
• Handbook of Sensory Physiology - rd.springer.com. (n.d.). Retrieved from https://rd.springer.com/content/pdf/bfm:978-3-642-88658-4/1.pdf
• Why Speech Rate? Why are results inconclusive? (n.d.). Retrieved from https://www.asha.org/Events/convention/handouts/2007/1337_Chon_Hee_Cheong/ Brown, R. (1973) A First Language London: Allen and Unwin.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 17, 2021): 6
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 30, 2020
• Actual Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Nonverbal-minimally verbal children (0-5 words)
• Diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

• No history of seizures for participating with VR goggles.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 8 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04764539
• Other Study ID Numbers: 1R43DC018447-01( U.S. NIH Grant/Contract ); 1R43DC018447-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: All data from individual participants will be kept private.

• Current Responsible Party: Lois Brady, iTherapy, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: iTherapy, LLC
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Not Provided
• PRS Account: iTherapy, LLC
• Verification Date: April 2023