Clinical Trials Logo

Clinical Trial Summary

The proposed research will test the efficacy of group conversation treatment for people with aphasia and explore whether the effects of treatment differ as a result of the following factors: 1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people with aphasia demonstrate different levels of improvement with this treatment? 2. Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia? 3. Aphasia severity: Do effects of conversation group treatment differ if the individuals within the group have mild-moderate or moderate-severe profiles of aphasia? Treatment sessions will occur in groups of 6-8 people with aphasia or with 2 people with aphasia. During treatment sessions, discourse will be facilitated on a focused set of every day topics, such as current events or travel. Linguistic and multi modal cueing hierarchies will be tailored to individual client goals and used to maximize communication success. The prediction is that conversation treatment is an effective method for improving communication in people with aphasia, but that specific benefits may differ based on variables such as group size, group composition, and aphasia severity. The results will help inform best practices for aphasia treatment and refine a hypothesized model about the mechanisms underlying conversation treatment.


Clinical Trial Description

Aphasia is a language disorder that affects approximately two million Americans. The communication barriers associated with aphasia limit the ability to return to work and hobbies, worsen social relationships, and lead to social isolation. Social isolation is correlated with many negative health outcomes, including mortality. As a result, the consequences of aphasia can be wide reaching and severe. Group treatment has the potential to improve communication and reduce social isolation, while also reducing medical costs. However, this treatment format lacks a strong evidence base. This research uses a hypothesis-driven approach to test the efficacy of conversation treatment and develop and refine a mechanistic pathway of how conversation treatment leads to behavioral changes in communication ability. We will systematically explore whether the effects of treatment differ as a result of number of participants (large group or dyad), group composition (heterogenous versus homogenous profiles of aphasia), and severity of aphasia. The study will enroll a total of 168 participants with aphasia across three sites. In cycle one, 72 participants will be randomly assigned to one of three conditions: dyad treatment, traditional group treatment or delayed control group. In cycles two and three, 48 participants with severe aphasia and 48 participants with mild-moderate aphasia will be randomly assigned to either large group or dyad conditions. In all cycles, treatment will occur for 60 minutes, twice per week for 10 weeks. During treatment sessions, a speech pathologist will facilitate discourse on a focused set of salient topics, such as current events, using individualized, linguistic and multimodal cueing hierarchies. The primary outcome measure is a functional measure of communication (Aphasia Communication Outcome Measure, ACOM; Hula et al., 2015). Secondary outcome measures will include standardized tests and patient reported outcome measures, and examine linguistic and functional communication abilities. All participants will be assessed pre-, post-, 4 weeks post- and 12 weeks post-treatment. The proposed research will address the following specific aims. Specific Aim 1 is to examine efficacy of conversation treatment delivered in dyads and large groups compared to a delayed-treatment control group. Specific Aim 2 is to determine optimal parameters for conversation treatment by testing whether the treatment effects differ as a function of aphasia severity (2A) or group composition (2B). Specific Aim 3 will test a hypothesized model of the pathway by which conversation treatment effects behavioral change. The results will provide further efficacy for conversation treatment and inform about the optimal parameters and outcomes of this intervention. This work takes a vital first step towards elucidating the mechanisms of change in conversation group treatment, with a long-term goal of ensuring access to cost-effective care for people with aphasia. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05113160
Study type Interventional
Source Boston University Charles River Campus
Contact Elizabeth Hoover, PhD
Phone (617) 353-8967
Email ehoover@bu.edu
Status Recruiting
Phase N/A
Start date April 15, 2022
Completion date April 30, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT05455463 - Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia N/A
Recruiting NCT05443633 - Enhancing Language Function in Aphasia N/A
Completed NCT04623125 - Spaced Retrieval as Treatment for Aphasia N/A
Not yet recruiting NCT04080817 - Neolexon® Aphasia-App in Acute Aphasia After Stroke N/A
Completed NCT02554513 - Apraxia of Speech: Comparison of EPG Treatment (Tx) and Sound Production Treatment (SPT) N/A
Completed NCT04488029 - PCT for Speech, Language, and Cognitive Intervention in Stroke Patients Phase 2
Completed NCT03287544 - Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke N/A
Not yet recruiting NCT05572385 - Clinic and Neurophysiology of Aphasia Treatment N/A
Recruiting NCT05687994 - Speech Entrainment Treatment for People With Aphasia N/A
Not yet recruiting NCT05667480 - VR and Script Training of PWA N/A
Completed NCT03292471 - Effects of rTMS on Brain Activation in Aphasia N/A
Completed NCT05338216 - Word Retrieval in the Wild in People With Post-Stroke Aphasia N/A
Recruiting NCT06185023 - Effects of High-intensity Exercise Training on Physical Fitness, Cognition, Language in Post-stroke Aphasia N/A
Completed NCT06068296 - Short-term Memory Assessment in Patients With Poststroke Aphasia N/A
Not yet recruiting NCT06092814 - tACS to Enhance Language Abilities N/A
Not yet recruiting NCT04828759 - Virtual Reality in Aphasia Telerehabilitation N/A