Communicative Interaction for ALS
Recruiting in Palo Alto (17 mi)
Overseen ByJimin Lee, Ph.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Penn State University
No Placebo Group
Trial Summary
What is the purpose of 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.
How does the treatment 'Communicative Interaction for ALS' differ from other treatments for ALS?
This treatment focuses on enhancing communication between people with ALS and their partners through structured and unstructured interactions, which is unique compared to other treatments that primarily address physical symptoms. It emphasizes the use of augmentative and alternative communication (AAC) strategies to maintain social connections and effectively convey important information, which is crucial for individuals with speech impairments due to ALS.
137910What data supports the effectiveness of the treatment Structured Communicative Interaction and Unstructured Communicative Interaction for ALS?
The research highlights the importance of timely communication support for ALS patients, as many experience severe speech difficulties. Augmentative and alternative communication (AAC) interventions are crucial, and their acceptance has increased, suggesting that structured communication strategies may help address communication needs in ALS.
24568Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Eligibility Criteria
This trial is for individuals with ALS (Lou Gehrig's disease) and their caregivers. It aims to understand how structured and unstructured communication affects verbal interaction over time. Participants will engage in reading tasks with their caregivers.Inclusion Criteria
I am a native American English speaker with ALS.
I have been diagnosed with ALS according to specific criteria.
I have ALS and no history of other neurological conditions.
I can speak single words despite having ALS.
I am a native American English speaker.
Participant Groups
The study examines two types of communicative interactions: structured, where specific guidelines are followed, and unstructured, which is more free-form. The impact on verbal communication between people with ALS and their caregivers is being measured.
1Treatment groups
Experimental Treatment
Group I: People with ALS and their caregiversExperimental Treatment2 Interventions
People with ALS and their caregivers will participate in structured communicative interaction.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Speech Core, Pennsylvania State UniversityUniversity Park, PA
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Who is running the clinical trial?
Penn State UniversityLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
Communication strategies of people with ALS and their partners. [2022]There are wider issues relating to the communication difficulties experienced by people with amyotrophic lateral sclerosis (ALS) than simply the physical problems caused by diminished oral control. In addition, existing literature on ALS rarely considers communication to be a joint interaction which depends on the strategies adopted by both communication partners, nor does it present communication in real life settings. This paper presents some of the findings from a 3-year research project which investigated the communication of people with ALS and their partners in their own homes. It discusses the purpose of human communication, and through examination of conversations in people's own homes has identified a range of strategies and techniques that families with ALS employ. For some people with ALS, although speech may deteriorate, they are still able to communicate closely and in a way that is more focused on topics that are particularly important to them. The findings from this study will be of interest to those who work with people with ALS.
Inter-evaluator reliability of the ALS functional rating scale. [2019]The ALS Functional Rating Scale-Revised (ALSFRS-R) is used in the clinic to chart progression and as a primary endpoint measure in clinical trials. In the original description of the scale, evaluations were to be performed by the patient or caregiver, but ratings are commonly performed by health care providers. We determined whether there are differences in scoring based on whether the provider, patient or caregiver performed the evaluation. Overall, all evaluators assessed similar changes in function over time, but significant visit-specific differences were found with higher scores when the patient and provider were the evaluators. We modeled how a change in evaluators at the end of a 9-month trial would influence statistical analysis, if the patient was unable to travel to the study site and the final assessment was performed by telephone. If 25% of the final visit assessments were performed by the patient, in place of the provider, the change in score is less than one point on the ALSFRS-R (-0.7: 95% Confidence Interval -2.1 to 0.3). We conclude that the ALSFRS-R can be successfully used even if evaluators change.
Purposes of AAC device use for persons with ALS as reported by caregivers. [2018]Thirty-four informal caregivers who support 26 persons with ALS reported on AAC technology use. Each caregiver completed the Communication Device Use Checklist, a survey tool developed for this study based on Light's (1988) classification of the purposes of social interaction (Augmentative and Alternative Communication, 4, 66-82). The checklist includes 17 purposes of communication and asks participants to judge importance, mode, and frequency of use for each purpose. Results show that the three communication purposes used most frequently and valued as important by caregivers involve regulating the behavior of others for basic needs and wants (getting needs met; giving instructions or directions to others; and clarifying needs). Consistent reports of use and frequency for the purposes of staying connected (social closeness) and discussing important issues (information transfer) indicate that AAC technology can assist the dyad in maintaining previous relationships. The face-to-face spontaneous conversation mode is used most frequently, despite the slow rate of production, the lack of permanence, and the demands on conversational partners during message generation. Clinical and research implications are discussed.
Outcome measures for early phase clinical trials. [2022]As the number of potential neuroprotective agents for ALS increases, the need for early phase trials that screen drugs before proceeding to efficacy trials also grows. However, it is not known which outcome measures perform best and also provide the most meaningful information in brief small trials. We assessed the performance of different outcome measures for use in early phase clinical trials in ALS, and determined what degree of change in the ALSFRS-R that patients could perceive. Thirty patients underwent six monthly ALS Functional Rating Scale (ALSFRS-R), forced vital capacity, manual muscle testing (MMT) and quality of life assessments. Patients rated their perceived level of change with algorithm scales. Linear mixed effects models assessed the associations among variables and Cox proportional-hazards models examined the ability to predict survival. The quantity of missing data was assessed using descriptive statistics. Correlations were found between all variables. The ALSFRS-R provided the most complete data (99.5%), showed a large within-subject correlation (0.91), and best predicted survival (p = 0.002). One-unit change in patient-perceived clinical function paralleled a 9-point decrease in the ALSFRS-R (p = 0.025; 95% CI 8, 10). This trial assessed just 30 patients over six months, but the standard outcome measures each performed dependably; all could be used in short-duration, early phase trials. The ALSFRS-R most strongly predicted survival and provided the most complete data, but large changes may be necessary before patients perceive treatment effects.
Communication Support for People with ALS. [2021]Almost all people with amyotrophic lateral sclerosis (ALS) experience a motor speech disorder, such as dysarthria, as the disease progresses. At some point, 80 to 95% of people with ALS are unable to meet their daily communication needs using natural speech. Unfortunately, once intelligibility begins to decrease, speech performance often deteriorates so rapidly that there is little time to implement an appropriate augmentative and alternative communication (AAC) intervention; therefore, appropriate timing of referral for AAC assessment and intervention continues to be a most important clinical decision-making issue. AAC acceptance and use have increased considerably during the past decade. Many people use AAC until within a few weeks of their deaths.
[Communication disorder in amyotrophic lateral sclerosis after ventilation--a proposal of staging and a study of predictive factor]. [2019]ALS patients supported by a ventilator often suffered from difficulty in communicating with others. We herein proposed a new classification of clinical stages of advanced ALS focusing on the degree of communication disturbance. We analyzed the relationship between clinical findings and the prognosis for communication disturbance. Twenty-nine ALS patients without dementia were enrolled in the study. The proposed classification consisted of five stages. Stage I: communicate in sentences, stage II: communicate with one word answers only, stage III: communicate with nonverbal yes/no response only, stage IV: cannot communicate occasionally due to uncertain yes/no responses, stage V: cannot communicate by any means. Clinical analysis showed that patients who reached stage V had begun to use the ventilator significantly earlier than patients with the final stages of IV or less. In addition, patients in stage V frequently had a family history of ALS. Rapid disease progression before ventilator use in patients with a family history might predict a poor long-term prognosis for communication disorder after using the ventilator.
Handwriting-in-interaction between people with ALS/MND and their conversation partners. [2022]The aim of this study was to examine the use and practices of handwriting-in-interaction by people with amyotrophic lateral sclerosis/motor neuron disease (ALS/MND). Handwriting has previously been described as a viable and practical means of augmentative and alternative communication, particularly for adults with acquired progressive dysarthria and intact upper limb control. To date, however, there is extremely limited evidence documenting how handwriting is used within a conversational context. The analysis in this paper features data from two people with ALS/MND in conversation at home with their spouses. It is shown how recipient animation of an authored written contribution is an important element of handwriting-in-interaction, particularly in how the recipient reveals his or her stance or reaction to whatever has been written.
Compliance with recommendations made in a multidisciplinary ALS clinic. [2016]Multidisciplinary ALS clinics provide recommendations at each visit, but these do little good unless recalled and followed. This study was conducted to determine recall of, and compliance with, these recommendations, and to study factors affecting compliance. Patients were contacted by telephone six weeks after their ALS clinic visit and asked about recommendations made by the multidisciplinary team. Themes for recall and compliance were generated by three coders using qualitative analysis, and validated using triangulation and consensual validation. Pearson correlation coefficients were calculated for the relationship of function and quality of life to recommendation categories. Results demonstrated that most recommendations centered around physical needs, whereas few were provided for Caregiver Support and Mental Health. Fewer than 40% of all recommendations were recalled, with the highest category being Physical Function. Compliance was highest for this category as well (mean 4.27/5). Monitoring of patients between clinic visits appeared to enhance compliance. In conclusion, for ALS clinic teams seeking to maximize the impact of recommendations, discussions to facilitate understanding, instruction in problem-solving skills, and closer follow-up between clinic visits should facilitate better recall and compliance, and thus improve care. The potential benefits of greater emphasis on mental health and caregiver well-being should be explored.
Characterizing social communication changes in amyotrophic lateral sclerosis. [2018]Speech and language impairments are well-established in individuals with amyotrophic lateral sclerosis (ALS). However, knowledge about particular aspects of social communication and everyday conversational abilities is limited.
"Augmentative and Alternative Communication (AAC) Will Give You a Voice": Key Practices in AAC Assessment and Intervention as Described by Persons with Amyotrophic Lateral Sclerosis. [2019]The purpose of this study was to describe the perceptions of persons with amyotrophic lateral sclerosis (pALS) who use augmentative and alternative communication (AAC) with the AAC assessment and intervention process. Twenty-one pALS with complex communication needs participated in a multipart survey (and follow-up e-mails) to provide information on their experiences with AAC assessment and intervention. A majority of the participants agreed with the importance of three key AAC intervention principles: appropriate staging of the timing of assessment and intervention activities, inclusion of communication partners, and the use of multiple modalities and strategies as communication supports. Most participants reported that their assessment and intervention experiences included at least some aspect of these three key practices. The results of this study suggest that the identified best practices in AAC should be reviewed and implemented on an individualized basis for pALS with complex communication needs.