Trial Outcomes & Findings for Video Assisted Speech Technology to Enhance Motor Planning for Speech (NCT NCT04764539)
NCT ID: NCT04764539
Last Updated: 2023-05-09
Results Overview
Change in % of correct phonemes in each attempted stimulus
COMPLETED
NA
6 participants
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.
2023-05-09
Participant Flow
Participant milestones
| Measure |
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).
|
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).
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|---|---|---|
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Overall Study
STARTED
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3
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3
|
|
Overall Study
COMPLETED
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3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Video Assisted Speech Technology to Enhance Motor Planning for Speech
Baseline characteristics by cohort
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized the tablet-based Video-Assisted Speech Therapy (VAST) application. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized a 3D VR-integrated Video-Assisted Speech Therapy (VAST) application, which paired bone conduction audio within a 3D-printed headset prototype. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).
|
Total
n=6 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
5.75 years
STANDARD_DEVIATION 2.113 • n=5 Participants
|
6 years
STANDARD_DEVIATION 1.938 • n=7 Participants
|
5.875 years
STANDARD_DEVIATION 1.818 • n=5 Participants
|
|
Sex: Female, Male
Female
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3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.Population: All participants for each respective group.
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.
Outcome measures
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
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).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
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).
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|---|---|---|
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Change in Mean Length of Utterance (MLU)
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0.5387 Morphemes per utterance
Standard Deviation 0.4119
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0.2987 Morphemes per utterance
Standard Deviation 0.4977
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PRIMARY outcome
Timeframe: 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.Population: All participants for each respective group.
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.
Outcome measures
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
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).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
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).
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|---|---|---|
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Change in Percentage of Correctly Transcribed Words Using Automatic Speech Recognition
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1.388 % of correctly transcribed words
Standard Deviation 1.966
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0 % of correctly transcribed words
Standard Deviation 0
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PRIMARY outcome
Timeframe: 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.Population: All participants for each respective group.
Change in % of correct phonemes in each attempted stimulus
Outcome measures
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
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).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
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).
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|---|---|---|
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Change in Articulation Accuracy
|
19.75 percentage of correct phonemes
Standard Deviation 28.71
|
16.24 percentage of correct phonemes
Standard Deviation 2.36
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SECONDARY outcome
Timeframe: 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.Population: All participants for each respective group.
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.
Outcome measures
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
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).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
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).
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|---|---|---|
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Parent Perceptions of Communication Changes, Resulting From Study Participation.
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11 Score on a scale
Standard Deviation 2.45
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9.67 Score on a scale
Standard Deviation 4.18
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SECONDARY outcome
Timeframe: 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.Population: All participants for each respective group.
A type-token ratio measures the total number of unique words in a given segment of language.
Outcome measures
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
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).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
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).
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|---|---|---|
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Change in Type-Token Ratios
|
30.158 number of unique words in a segment
Standard Deviation 24.5
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22.26 number of unique words in a segment
Standard Deviation 41.18
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SECONDARY outcome
Timeframe: 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.Population: All participants for each respective group.
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.
Outcome measures
| Measure |
Stimuli Administered Via 2D Format on an iPad Pro
n=3 Participants
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).
|
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
n=3 Participants
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).
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|---|---|---|
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Increase in Response Rate to Treatment Stimuli
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5.67 Number of responses
Standard Deviation 3.4
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3.33 Number of responses
Standard Deviation 4.03
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Adverse Events
Stimuli Administered Via 2D Format on an iPad Pro
Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place