Examining Interactions Between PALS and Caregivers
ConditionAmyotrophic Lateral Sclerosis (ALS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPenn State University
About this trial
The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers.
The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time?
Participants will read words and sentences while they are interacting with their caregivers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
diagnosis of ALS following the revised EL Escorial criteria
no history of other neurological conditions (e.g., stroke)
no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)
detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R)
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Structured Communicative Interaction
BehavioralTwo interlocutors, one with ALS and their caregiver will work together. Each participant in the pair will view the same set of words on their screens. After one second, one of the words will be highlighted on the speaker's screen, they will say the word in the phrase "Click on the \_\_\_\_ this time", and the listener will click on it. After the listener has made their selection, both participants will receive feedback on trial success.
Unstructured communicative interaction
BehavioralTwo interlocutors, one with ALS and their caregiver will work together. The pairs will be presented with two different versions of the same picture with eight differences chosen to elicit the same target segments (e.g., "hid", "ship", "net"). These pictures will be modified from the LUCID corpus. In total, pairs will complete four picture sets per session. Pairs will be given 5 minutes for each picture set.
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: People with ALS and their caregiversExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Formant frequencies of speech sounds
Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task.
Time frame
two 60 minute sessions2
Intelligibility of recorded speech
Perceptual judgments will be provided by solo, naïve listeners who did not participate in the interactions. Listeners will hear recorded speech of PALS and age-matched speakers recorded across the different tasks and indicate what they heard. The score will be expressed in percent. The possible range is between 0-100%. The higher scores mean a better outcome.
Time frame
two 60 minute sessions3
Syntactic properties
Syntactic complexity in the unstructured communication task will be measured through mean length of grammatical units, clausal density, and clause type. Each variable will be assessed at both the dyadic level (e.g., clausal density for both interlocutors together) and at the level of the individual speaker (e.g., clausal density of each speaker). A composite of these measures will provide an index of the syntactic complexity of the conversation.
Time frame
Two 60 minute sessions4
Pragmatic Properties
The investigators will count the number and duration of silent portions of speech, filled pauses, linguistic mazes, speaking turns, and interruptions in the unstructured communication task. A composite measure of the individual measures will provide an index of an individual's contribution to the conversation.
Time frame
Two 60 minute sessionsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Penn State University
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov