Finding the Right Words in Neurogenic Communication Disorders
Primary Purpose
Anomia, Stroke, Aphasia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Semantic feature analysis
Comprehension training
Sponsored by
About this trial
This is an interventional treatment trial for Anomia focused on measuring Anomia
Eligibility Criteria
Inclusion Criteria:
- Subjective experience of word finding difficulties
- Diagnosed left hemisphere stroke or Parkinson's disease or MS
- With correction, sufficient hearing and vision to be able to participate in the assessment
- Participants with stroke at least six months post-onset and documented location of injury.
Exclusion Criteria:
- Mother tongue other than Swedish
- Moderately or severely impaired comprehension
- Other neurological injury or disease
- Moderate-severe apraxia of speech or dysarthria
- Fatigue or impaired attention deficit which prevents participating in intensive training
Sites / Locations
- University of Gothenburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SFA treatment
Comprehension training
Arm Description
Semantic feature analysis
Comprehension training
Outcomes
Primary Outcome Measures
Naming ability in the Object & Action Naming Battery
A measure of change in ability to name forty pictures consisting of simple black and white drawings. There is a 20-second time limit for response for each picture. Number of correct objects and activities will be calculated separately (range 0-20) as well as summarized (range 0-40)
Secondary Outcome Measures
Sustained change in naming ability in the Object & Action Naming Battery
A measure of change in ability to name forty pictures consisting of simple black and white drawings. There is a 20-second time limit for response for each picture. Number of correct objects and activities will be calculated separately (range 0-20) as well as summarized (range 0-40)
Naming of 20 individually chosen training words
A measure of change in ability to name objects and action words participants have chosen to practice
Sustained change in naming of 20 individually chosen training words
A measure of change in ability to name objects and action words participants have chosen to practice
The Communication Outcome After Stroke (COAST) scale
A measure of change in participants perception of the communicative ability from baseline to after intervention. COAST comprises 20 items where participants rates themselves on a 5-graded likert scale. The scale is running from 1) "couldn't do it at all, through 2) "with a lot of difficulty", 3) "with some difficulty", 4) "quite well" to 5) "very well". The scoring of each item will be summarized and averaged (total range 0-5) and a higher score indicates perceptions of better communicative ability.
Sustained change in the Communication Outcome After Stroke (COAST) scale
A measure of change in participants perception of the communicative ability twelve weeks after intervention is completed. COAST comprises 20 items where participants rates themselves on a 5-graded likert scale. The scale is running from The scale is running from 1) "couldn't do it at all, through 2) "with a lot of difficulty", 3) "with some difficulty", 4) "quite well" to 5) "very well". The scoring of each item will be summarized and averaged (total range 0-5) and a higher score indicates perceptions of better communicative ability.
The Stroke Aphasia Quality of Life (SAQOL-39)
A measure of change after intervention 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. Scores range from 1 to 5 in each sub domain and are averaged; higher scores indicate better quality of life. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score (range 1-5).
Sustained change in the Stroke Aphasia Quality of Life (SAQOL-39)
A measure of change 12 weeks after intervention is completed 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. Scores range from 1 to 5 in each sub domain and are averaged; higher scores indicate better quality of life. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score (range 1-5).
The Communicative Participation Item Bank (CPIB)
A measure of change from baseline to after intervention in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used - participants rates their perception of degree of participation on a four-graded scale where higher scores indicate higher degree of participation. The scale runs from 0) "very much", through 1) "quite a bit", 2) "a little", to 3) "not at all". The scoring of each item will be summarized into a total score (range 0-30).
Sustained change in the Communicative Participation Item Bank (CPIB)
A measure of change 12 weeks after the completion of the intervention in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used - participants rates their perception of degree of participation on a four-graded scale where higher scores indicate higher degree of participation. The scale runs from 0) "very much", through 1) "quite a bit", 2) "a little", to 3) "not at all". The scoring of each item will be summarized into a total score (range 0-30).
Retelling of events in video clips
A measure of change in ability to retell and describe events from baseline to after intervention is completed.The participants view short video clips with a character involved with different activities including objects and are asked to retell what happened every tenth second.
Sustained change in retelling of events in video clips
A measure of change in ability to retell and describe events from after the completion of intervention to a 12 weeks follow up. The participants view short video clips with a character involved with different activities including objects and are asked to retell what happened every tenth second.
Full Information
NCT ID
NCT03568760
First Posted
May 21, 2018
Last Updated
March 15, 2022
Sponsor
Göteborg University
Collaborators
The Swedish Research Council, Swedish Council for Working Life and Social Research
1. Study Identification
Unique Protocol Identification Number
NCT03568760
Brief Title
Finding the Right Words in Neurogenic Communication Disorders
Official Title
Finding the Right Words in Neurogenic Communication Disorders: Naming of Objects and Actions, Communicative Strategies in Conversation and Effects of Training
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
The Swedish Research Council, Swedish Council for Working Life and Social Research
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
Every year thousands of persons suffer from brain damage resulting in anomia, that is, word finding difficulties affecting their ability to talk to other people. Anomia may be a result of stroke or of progressive neurological diseases such as Parkinson's disease or multiple sclerosis (MS). Word retrieval is dependent on a complex system of different neural networks and to name objects and activities can be affected to different degrees. The present project explores different aspects of naming ability in altogether 90 persons that has anomia related to stroke or to Parkinson's disease or MS. Furthermore, the communicative strategies and resources used by conversation partners in everyday conversational interaction and in care situations, affected by anomia are studied. Finally, the project includes a study of the effectiveness of a word finding training program based on stimulation of semantic and phonological networks in the brain, involved in the production of words. There is a lack of research on effects on communication from anomia in Parkinson's disease and MS and there is no research on anomia that investigates both object and action naming using a material adapted to the Swedish language. In the project quantitative and qualitative methods are used to explore and describe how persons with different neurogenic communication disorders can use different resources and communicative strategies to express themselves.
Detailed Description
Project out line
The main project consists of:
A descriptive study of the occurrence and type of naming difficulties in people with stroke, Parkinson's disease or Multiple sclerosis (MS) where quantitative data is compared at group level, (study 1).
A descriptive study in which word search strategies are investigated with both quantitative and qualitative methods (study 2).
A series of three intervention studies examining the effect of treatment of anomia (studies 3-5).
Study 1: The relation between type of injury and ability to name objects and actions and complex semantic-pragmatic word fluency
Participants The project includes a total of 90 people with anomia: 50 subjects with anomia after stroke, 20 individuals with Parkinson's disease and 20 individuals with MS are recruited are recruited through patient associations and health care facilities in Västra Götaland and included consecutively.
In the study confrontation naming ability, and word fluency is explored. In addition, the type of naming difficulties and consequences of anomia in everyday communication are examined with a questionnaire and communication analysis.
1) Confrontation naming ability is examined with a material consisting of 42 images representing 21 nouns and 21 verbs. The selection of images comes from The Object & Action Naming Battery and is adapted to Swedish linguistic and cultural conditions. The images consist of simple black and white drawings. There is a 20-second time limit for response for each image. In addition to scoring, an analysis and categorization of the response according to the coding scheme is performed; 2) Word fluency is examined with semantic (animals and activities) and phonological (F, A and S) word fluency tests where the participant will produce as many words as possible for each category during one minute. The results are compared with reference data for healthy participants and the use of strategies is analyzed by calculating cluster size and number of switches between different categories; a more complex semantic-pragmatic word fluency task is also administrated.
Participants' experience of their communication skills in everyday life and quality of life is gathered in a questionnaire with image support: The Communication Outcome After Stroke (COAST) scale. COAST consists of 20 questions where participants estimate themselves on a 5-degree likert scale. Stroke and Aphasia Quality of Life Scale (SAQOL-39) and Communicative Participation Item Bank (CPIB) are also administrated as well as a formalized interview.
Study 2: Word search strategies in naming difficulties in people with different types of neurogenic communication disorders
Participants In this descriptive study fifteen participants with Parkinson's disease and fifteen participants with MS are included.
Material and methods Word search strategies in ten-twenty minutes of naturally occurring conversations are assessed through communication analysis. Sequences where participants are involved in repair due to difficulties to express themselves are analyzed with the qualitative method Conversation Analysis in combination med Aktivity based communication analysis.
Studies 3-4: Training with semantic feature analysis to improve naming
Participants Six participants with MS and six participants with Parkinson's disease and 40 participants with anomia due to stroke will be included.
Intervention Participants receive training in semantic feature analysis (SFA) for naming of objects and activities. The training is administered by presenting an image representing either an object or an activity are presented to the participant. The participant is encouraged to try to produce the target word as well as a number of words semantically related to the target word. The related words are listed in a certain order and describe different semantic aspects of the target word. The participants get to choose a number of words which they want to practice.
The participants receive training at 20 occasions, three times a week. The training is delivered during one hour each session in individual training for the participants with MS and in a group setting for two hours, including 30 minutes pause for participants with stroke
Study 3-4 - training anomia due to Parkinson's disease and MS Since semantic feature analysis has not previously been used as treatment for people with Parkinson's disease or MS, the effect is evaluated in using time series design with multiple baselines. Three-five baseline measures of the dependent variable is collected before start of training and then every fourth training session.
Study 5 - training anomia due to stroke In study 5 the effect of intervention for participants with anomia due to stroke is assessed in a randomized group study with a control group. The control group receives training in comprehension. The groups are matched in terms of age, severity of anomia time since onset and level of education. Before and after the intervention, as well as at a twelve week follow up, the effects are assessed in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anomia, Stroke, Aphasia, Parkinson Disease, Multiple Sclerosis
Keywords
Anomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The results are assessed by independent assessors blinded to when the data is obtained and from which group.
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SFA treatment
Arm Type
Experimental
Arm Description
Semantic feature analysis
Arm Title
Comprehension training
Arm Type
Placebo Comparator
Arm Description
Comprehension training
Intervention Type
Behavioral
Intervention Name(s)
Semantic feature analysis
Intervention Description
Confrontation naming training and training in doing circumlocutions
Intervention Type
Behavioral
Intervention Name(s)
Comprehension training
Intervention Description
Reading and hearing comprehension
Primary Outcome Measure Information:
Title
Naming ability in the Object & Action Naming Battery
Description
A measure of change in ability to name forty pictures consisting of simple black and white drawings. There is a 20-second time limit for response for each picture. Number of correct objects and activities will be calculated separately (range 0-20) as well as summarized (range 0-40)
Time Frame
At baseline before start of intervention and after 21 days, at completion the intervention program
Secondary Outcome Measure Information:
Title
Sustained change in naming ability in the Object & Action Naming Battery
Description
A measure of change in ability to name forty pictures consisting of simple black and white drawings. There is a 20-second time limit for response for each picture. Number of correct objects and activities will be calculated separately (range 0-20) as well as summarized (range 0-40)
Time Frame
At a twelve week follow up after the completion of the intervention
Title
Naming of 20 individually chosen training words
Description
A measure of change in ability to name objects and action words participants have chosen to practice
Time Frame
At baseline before start of intervention and after 21 days, at completion the intervention program
Title
Sustained change in naming of 20 individually chosen training words
Description
A measure of change in ability to name objects and action words participants have chosen to practice
Time Frame
At a twelve week follow up after the completion of the intervention
Title
The Communication Outcome After Stroke (COAST) scale
Description
A measure of change in participants perception of the communicative ability from baseline to after intervention. COAST comprises 20 items where participants rates themselves on a 5-graded likert scale. The scale is running from 1) "couldn't do it at all, through 2) "with a lot of difficulty", 3) "with some difficulty", 4) "quite well" to 5) "very well". The scoring of each item will be summarized and averaged (total range 0-5) and a higher score indicates perceptions of better communicative ability.
Time Frame
At baseline before start of intervention and after 21 days, at completion the intervention program
Title
Sustained change in the Communication Outcome After Stroke (COAST) scale
Description
A measure of change in participants perception of the communicative ability twelve weeks after intervention is completed. COAST comprises 20 items where participants rates themselves on a 5-graded likert scale. The scale is running from The scale is running from 1) "couldn't do it at all, through 2) "with a lot of difficulty", 3) "with some difficulty", 4) "quite well" to 5) "very well". The scoring of each item will be summarized and averaged (total range 0-5) and a higher score indicates perceptions of better communicative ability.
Time Frame
At a twelve week follow up after the completion of the intervention
Title
The Stroke Aphasia Quality of Life (SAQOL-39)
Description
A measure of change after intervention 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. Scores range from 1 to 5 in each sub domain and are averaged; higher scores indicate better quality of life. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score (range 1-5).
Time Frame
At baseline before start of intervention and after 21 days, at completion the intervention program
Title
Sustained change in the Stroke Aphasia Quality of Life (SAQOL-39)
Description
A measure of change 12 weeks after intervention is completed 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. Scores range from 1 to 5 in each sub domain and are averaged; higher scores indicate better quality of life. Scoring in each domain will be summarized and averaged and presented separately as well as in a compound averaged score (range 1-5).
Time Frame
At a follow up twelve weeks after completion of intervention
Title
The Communicative Participation Item Bank (CPIB)
Description
A measure of change from baseline to after intervention in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used - participants rates their perception of degree of participation on a four-graded scale where higher scores indicate higher degree of participation. The scale runs from 0) "very much", through 1) "quite a bit", 2) "a little", to 3) "not at all". The scoring of each item will be summarized into a total score (range 0-30).
Time Frame
At baseline before start of intervention and after 21 days, at completion the intervention program
Title
Sustained change in the Communicative Participation Item Bank (CPIB)
Description
A measure of change 12 weeks after the completion of the intervention in participants' perceptions of their communicative participation in everyday life activities. A short form of the item bank with ten items are used - participants rates their perception of degree of participation on a four-graded scale where higher scores indicate higher degree of participation. The scale runs from 0) "very much", through 1) "quite a bit", 2) "a little", to 3) "not at all". The scoring of each item will be summarized into a total score (range 0-30).
Time Frame
At a 12 week follow up after the completion of the intervention
Title
Retelling of events in video clips
Description
A measure of change in ability to retell and describe events from baseline to after intervention is completed.The participants view short video clips with a character involved with different activities including objects and are asked to retell what happened every tenth second.
Time Frame
At baseline before start of intervention and after 21 days, at completion the intervention program
Title
Sustained change in retelling of events in video clips
Description
A measure of change in ability to retell and describe events from after the completion of intervention to a 12 weeks follow up. The participants view short video clips with a character involved with different activities including objects and are asked to retell what happened every tenth second.
Time Frame
At a 12 week follow up after the completion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjective experience of word finding difficulties
Diagnosed left hemisphere stroke or Parkinson's disease or MS
With correction, sufficient hearing and vision to be able to participate in the assessment
Participants with stroke at least six months post-onset and documented location of injury.
Exclusion Criteria:
Mother tongue other than Swedish
Moderately or severely impaired comprehension
Other neurological injury or disease
Moderate-severe apraxia of speech or dysarthria
Fatigue or impaired attention deficit which prevents participating in intensive training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotta Saldert
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
City
Gothenburg
State/Province
Västra Göraland
ZIP/Postal Code
405 30
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18452499
Citation
Tallberg IM, Ivachova E, Jones Tinghag K, Ostberg P. Swedish norms for word fluency tests: FAS, animals and verbs. Scand J Psychol. 2008 Oct;49(5):479-85. doi: 10.1111/j.1467-9450.2008.00653.x. Epub 2008 Apr 29.
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
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
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
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Finding the Right Words in Neurogenic Communication Disorders
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