Effects of Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
Primary Purpose
Anomia, Aphasia, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Verb Network Strengthening Treatment (VNeST)
Sponsored by
About this trial
This is an interventional treatment trial for Anomia
Eligibility Criteria
Inclusion Criteria:
- Aphasia and subjective experience of word finding difficulties
- Diagnosed left-hemisphere stroke at least six months post-onset
- With correction, sufficient hearing and vision to be able to participate in training and assessment
- Primarily speaking Swedish for at least the last 15 years
Exclusion Criteria:
- Other neurological injury or disease
- Moderately or severely impaired comprehension
- Moderate-severe apraxia of speech or dysarthria which may interfere with assessment
- Participation in any other speech-language treatment during the study
- Active substance dependence
Sites / Locations
- University of Gothenburg, Västra GötalandsregionenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telepractice treatment (TP-T)
In-clinic treatment (IC-T)
Arm Description
Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST). Treatment will be done with a speech-language pathologist providing the therapy through an online platform.
Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST). Treatment will be done with a speech-language pathologist providing the therapy in person at a clinic.
Outcomes
Primary Outcome Measures
Change from baseline in naming ability of trained items at week 10.
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Change from baseline in naming ability of trained items at week 20.
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Secondary Outcome Measures
Change from baseline in naming ability of untrained items at week 10.
A measure of generalization of treatment effects to naming of ten untrained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Change from baseline in naming ability of untrained items at week 20.
A measure of generalization of treatment effects to naming of ten untrained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Change from baseline in confrontation naming of single words (objects and actions) at week 10.
The Object & Action Naming Battery (Masterson & Druks, 1998) is a measure of change in ability to name forty pictures consisting of simple black and white drawings of objects and actions. Possible score range: 0 (worst) to 40 (best).
Change from baseline in confrontation naming of single words (objects and actions) at week 20.
The Object & Action Naming Battery (Masterson & Druks, 1998) is a measure of change in ability to name forty pictures consisting of simple black and white drawings of objects and actions. Possible score range: 0 (worst) to 40 (best).
Change from baseline in confrontation naming of single words (objects) at week 10.
The Boston naming test (Goodglass et al, 1983) is a measure of change in ability to name sixty simple black and white drawings of objects. Possible score range 0 (worst) to 60 (best).
Change from baseline in confrontation naming of single words (objects) week 20.
The Boston naming test (Goodglass et al, 1983) is a measure of change in ability to name sixty simple black and white drawings of objects. Possible score range 0 (worst) to 60 (best).
Change from baseline in connected speech at week 10.
Connected speech tasks (Nicholas & Brookshire, 1993) measures of change in ability to retrieve words in a picture description tasks, a procedural information task and in sharing personal information tasks. The speech produced in each task is analysed and number of words and adequate information units produced is calculated and related to time taken to produce the information. Higher numbers are better results.
Change from baseline in connected speech at week 20.
Connected speech tasks (Nicholas & Brookshire, 1993) measures of change in ability to retrieve words in a picture description tasks, a procedural information task and in sharing personal information tasks. The speech produced in each task is analysed and number of words and adequate information units produced is calculated and related to time taken to produce the information. Higher numbers are better results.
Change from baseline in self reported communicative participation in everyday life at week 10.
The Communicative Participation Item Bank (CPIB; Baylor et al 2013) is a validated measure of change in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used. The scoring of each item will be summarized into a total score with the range 0 (worse) to 30 (best).
Change from baseline in self reported communicative participation in everyday life at week 20.
The Communicative Participation Item Bank (CPIB; Baylor et al 2013) is a validated measure of change in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used. The scoring of each item will be summarized into a total score with the range 0 (worse) to 30 (best).
Change from baseline in self reported quality of life at week 10.
The Stroke Aphasia Quality of Life (SAQOL-39, Hilari et al 2009) is a validated measure of change in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score. Possible score range is 1 (worse) to 5 (best).
Change from baseline in self reported quality of life at week 20.
The Stroke Aphasia Quality of Life (SAQOL-39, Hilari et al 2009) is a validated measure of change in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score. Possible score range is 1 (worse) to 5 (best).
Full Information
NCT ID
NCT05152979
First Posted
October 18, 2021
Last Updated
March 15, 2022
Sponsor
Göteborg University
Collaborators
The Swedish Research Council
1. Study Identification
Unique Protocol Identification Number
NCT05152979
Brief Title
Effects of Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
Official Title
Effects of On-line and In-clinic Intervention With Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
The Swedish Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although there is evidence that speech-language therapy may improve speech in language disorders following left hemisphere stroke there is still a lack of evidence for which types of therapy are effective. Furthermore, in Sweden, as well as in several other countries, access to speech-language therapy is limited. The purpose of this clinical trial is to compare outcome from Verb Network Strengthening Treatment (VNeST) provided as In-Clinic therapy (I-CT) or as synchronous telepractice therapy (TP-T).
Detailed Description
Every year thousands of persons in Sweden suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia is one of the most common and persistent symptoms of aphasia following a left hemisphere stroke, but it is also common in in progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). There is evidence that more intensive speech language therapy may improve speech even in a chronic (> six month post stroke) phase of aphasia. However, access to the necessary amount of speech language therapy is limited due to lack of financial resources as well as to limitations to service providers in more rural areas.
It has been suggested that telepractice may increase the access to speech-language therapy for more people but there is a lack of knowledge of whether there is a difference in outcome from interventions provided as In-Clinic therapy (I-CT) or as telepractice therapy (TP-T).
Verb Network Strengthening Treatment (VNeST) is an anomia therapy focused on the production of short phrases. The participants generate thematically related verbs and nouns to strengthen the neural connections between the action (verb) and related thematic roles (agents and patients). From orally and written stimuli, the participants are asked to tell whom (subject) may do something (verb) with what (object) and then to do short expansions from this basic phrase. So far, results from single-case experimental design studies performed by Edmonds and colleagues are promising, showing generalization of outcomes to untrained items. Moreover, improvement in word finding was observed in other tasks like object and verb naming as well as sentence production and partly to connected speech.
The present project explores the effectiveness of VNeST, first in a small pilot study, then in a clinical trial including 80 participants. Participants with left hemisphere aphasia will be randomized to either an in-clinic therapy (I-CT) group or a telepractice therapy (TP-T) group and provided VNeST following the same treatment protocol based on Edmonds (2014).
Outcome measure include measures of naming ability on word- and phrase levels as well as in discourse. Measures of participant reported perceptions of functional communication and communicative participation as well as health related quality of life (PROMs) are also included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anomia, Aphasia, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
Outcomes Assessor
Masking Description
The results are assessed by independent assessors blinded to in which phase (pre-post-follow up) the data is obtained, and partly to conditions for therapy (In-Clinic or Telepractice).
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telepractice treatment (TP-T)
Arm Type
Experimental
Arm Description
Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST).
Treatment will be done with a speech-language pathologist providing the therapy through an online platform.
Arm Title
In-clinic treatment (IC-T)
Arm Type
Active Comparator
Arm Description
Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST).
Treatment will be done with a speech-language pathologist providing the therapy in person at a clinic.
Intervention Type
Behavioral
Intervention Name(s)
Verb Network Strengthening Treatment (VNeST)
Intervention Description
Participants are presented with a verb (representing an activity, for example, driving) orally and in writing. The participants are first asked to name someone who may perform the given activity (an agent, for example, a chauffeur), then to name an object which the given activity may be performed with (a patient, for example, a limousine). Several types of semantic clues and assistance are provided if the participant is having difficulties finding adequate nouns. This procedure is repeated for three different agents and objects related to the given verb. The participants are then asked to choose one of the three phrases participants have created and expand on it by telling where, when and why the agent is performing the activity. After this the participant are given sentences (with several foils) including the activity as well as agents and patients, and are asked to indicate whether the sentences are correct or not.
Primary Outcome Measure Information:
Title
Change from baseline in naming ability of trained items at week 10.
Description
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in naming ability of trained items at week 20.
Description
Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Time Frame
Baseline, 20 weeks.
Secondary Outcome Measure Information:
Title
Change from baseline in naming ability of untrained items at week 10.
Description
A measure of generalization of treatment effects to naming of ten untrained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in naming ability of untrained items at week 20.
Description
A measure of generalization of treatment effects to naming of ten untrained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).
Time Frame
Baseline, 20 weeks.
Title
Change from baseline in confrontation naming of single words (objects and actions) at week 10.
Description
The Object & Action Naming Battery (Masterson & Druks, 1998) is a measure of change in ability to name forty pictures consisting of simple black and white drawings of objects and actions. Possible score range: 0 (worst) to 40 (best).
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in confrontation naming of single words (objects and actions) at week 20.
Description
The Object & Action Naming Battery (Masterson & Druks, 1998) is a measure of change in ability to name forty pictures consisting of simple black and white drawings of objects and actions. Possible score range: 0 (worst) to 40 (best).
Time Frame
Baseline, 20 weeks.
Title
Change from baseline in confrontation naming of single words (objects) at week 10.
Description
The Boston naming test (Goodglass et al, 1983) is a measure of change in ability to name sixty simple black and white drawings of objects. Possible score range 0 (worst) to 60 (best).
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in confrontation naming of single words (objects) week 20.
Description
The Boston naming test (Goodglass et al, 1983) is a measure of change in ability to name sixty simple black and white drawings of objects. Possible score range 0 (worst) to 60 (best).
Time Frame
Baseline, 20 weeks.
Title
Change from baseline in connected speech at week 10.
Description
Connected speech tasks (Nicholas & Brookshire, 1993) measures of change in ability to retrieve words in a picture description tasks, a procedural information task and in sharing personal information tasks. The speech produced in each task is analysed and number of words and adequate information units produced is calculated and related to time taken to produce the information. Higher numbers are better results.
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in connected speech at week 20.
Description
Connected speech tasks (Nicholas & Brookshire, 1993) measures of change in ability to retrieve words in a picture description tasks, a procedural information task and in sharing personal information tasks. The speech produced in each task is analysed and number of words and adequate information units produced is calculated and related to time taken to produce the information. Higher numbers are better results.
Time Frame
Baseline, 20 weeks.
Title
Change from baseline in self reported communicative participation in everyday life at week 10.
Description
The Communicative Participation Item Bank (CPIB; Baylor et al 2013) is a validated measure of change in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used. The scoring of each item will be summarized into a total score with the range 0 (worse) to 30 (best).
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in self reported communicative participation in everyday life at week 20.
Description
The Communicative Participation Item Bank (CPIB; Baylor et al 2013) is a validated measure of change in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used. The scoring of each item will be summarized into a total score with the range 0 (worse) to 30 (best).
Time Frame
Baseline, 20 weeks.
Title
Change from baseline in self reported quality of life at week 10.
Description
The Stroke Aphasia Quality of Life (SAQOL-39, Hilari et al 2009) is a validated measure of change in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score. Possible score range is 1 (worse) to 5 (best).
Time Frame
Baseline, 10 weeks.
Title
Change from baseline in self reported quality of life at week 20.
Description
The Stroke Aphasia Quality of Life (SAQOL-39, Hilari et al 2009) is a validated measure of change in participant reported health related quality of life in a questionnaire with 39 items where participants evaluate of their everyday functioning in three domains: physical, psychosocial and communication. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score. Possible score range is 1 (worse) to 5 (best).
Time Frame
Baseline, 20 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aphasia and subjective experience of word finding difficulties
Diagnosed left-hemisphere stroke at least six months post-onset
With correction, sufficient hearing and vision to be able to participate in training and assessment
Primarily speaking Swedish for at least the last 15 years
Exclusion Criteria:
Other neurological injury or disease
Moderately or severely impaired comprehension
Moderate-severe apraxia of speech or dysarthria which may interfere with assessment
Participation in any other speech-language treatment during the study
Active substance dependence
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotta Saldert, Prof
Phone
+46317865662
Email
charlotta.saldert@neuro.gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Longoni, Dr
Phone
+46317866886
Email
francesca.longoni@neuro.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotta Saldert, Prof
Organizational Affiliation
Inst of Neurosci & Physiology, Speech & Language Pathology Unit, University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Gothenburg, Västra Götalandsregionen
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
40530
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joana Kristensson, Dr
Phone
+46313425560
Email
joana.kristensson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Charlotta Saldert
Phone
+46317865662
Email
charlotta.saldert@neuro.gu.se
12. IPD Sharing Statement
Citations:
PubMed Identifier
23816661
Citation
Baylor C, Yorkston K, Eadie T, Kim J, Chung H, Amtmann D. The Communicative Participation Item Bank (CPIB): item bank calibration and development of a disorder-generic short form. J Speech Lang Hear Res. 2013 Aug;56(4):1190-208. doi: 10.1044/1092-4388(2012/12-0140). Epub 2013 Jul 1.
Results Reference
background
Citation
Edmonds LA. Tutorial for Verb Network Strengthening Treatment (VNeST): Detailed Description of the Treatment Protocol with Corresponding Theoretical Rationale. Perspectives on Neurophysiology & Neurogenic Speech & Language Disorders. 2014; 24(3): 78-88
Results Reference
background
Citation
Goodglass H, Kaplan E, Weintraub S. Boston Naming Test. Philadelphia, PA: Lea & Febiger. 1983.
Results Reference
background
PubMed Identifier
19447841
Citation
Hilari K, Lamping DL, Smith SC, Northcott S, Lamb A, Marshall J. Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population. Clin Rehabil. 2009 Jun;23(6):544-57. doi: 10.1177/0269215508101729. Epub 2009 May 15.
Results Reference
background
PubMed Identifier
19052247
Citation
Long A, Hesketh A, Paszek G, Booth M, Bowen A. Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale. Clin Rehabil. 2008 Dec;22(12):1083-94. doi: 10.1177/0269215508090091.
Results Reference
background
Citation
Masterson J, Druks J. Description of a set of 164 nouns and 102 verbs matched for printed word frequency, familiarity and age-of-acquisition. Journal of Neurolinguistics. 1998; 11: 331-54.
Results Reference
background
PubMed Identifier
8487525
Citation
Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
Results Reference
background
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Effects of Verb Network Strengthening Treatment (VNeST) on Word Finding in Aphasia
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