AphasiaNCT04604444
Changes in Neuroplasticity Following Intensive Rehabilitation of Aphasia and/or Apraxia of Speech
A study testing Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech in people with Aphasia and Apraxia of Speech, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The present study aims to investigate the short- and long-term effects of two weeks of intensive speech-language pathology intervention with additional physiotherapy, on aphasia and apraxia of speech (AOS) and their neural correlates in thirty persons with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aphasia, Apraxia of Speech, Dysarthria
- What is being tested?
- Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 2 Feb 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aphasia 7 months post stroke diagnosed by SLP
- Apraxia of Speech 7 months post stroke diagnosed by SLP
Who cannot join
- Dementia
- Severe loss of sight
- Severe loss of hearing
- Metal implants (preventing fMRI)
- Claustrophobia (preventing fMRI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala Universitet
Uppsala, 141 86
Marika Schütz, Ph.D student, 0046737570430, marika.schutz@uu.se
About this study
Official title: Evaluating the Effects of Intensive Speech and Language Rehabilitation Regarding Neuroplasticity, Speech, Language, Communication Skills and Quality of Life for People With Acquired Aphasia and/or Apraxia of Speech in the Chronic Phase
The present study aims to investigate the short- and long-term effects of two weeks of intensive speech-language pathology intervention with additional physiotherapy, on aphasia and apraxia of speech (AOS) and their neural correlates in thirty persons with chronic stroke. Changes are studied following intensive treatment of aphasia and AOS with standardised speech-language testing and testing of communication and with voxel-based morphometry (VBM) analysis and resting state functional connectivity (rsFC).
Read the detailed description
This study explores structural and functional brain changes in relation to effects on speech, language, communication and quality of life following an intensive speech-language program with additional physiotherapy for persons with chronic aphasia and/or apraxia of speech. The participants are consecutively recruited from a rehabilitation centre providing intensive treatment for chronic conditions following stroke or other neurological injuries. The speech-language pathologists (SLPs) involved in the rehabilitation programs perform the testing directly before and after intensive intervention with an additional follow up after 16 weeks (+-2) with testing of speech-language, communication and quality of life. The SLPs have more than five years of experience of working with aphasia and are specialised in working with intensive treatment, they have acquired in-depth knowledge on how to evaluate and treat aphasia and apraxia of speech in lectures and workshops. The test procedure is recorded with camcorder and voice recorder to provide the opportunity to access data retrospectively and to minimize bias by including an external SLP who makes a second blinded evaluation on randomized participants' performance in ASRS, BNT and CAT by studying the video and voice material. Structural and functional neuroplasticity is also investigated with voxel-based morphometry (VBM) analysis, resting state functional connectivity (rsFC) in domain-specific (language processing) and domain-general (executive and attention processing). This intensive neuro-rehabilitation program for speech and language deficits named Multimodal Intensive Rehabilitation for Aphasia and Apraxia of Speech (MIRAA) is defined as an ICAP (Intensive Comprehensive Aphasia Program) with focus on both speech and language function and communicative activity and participation. The program is intensive: consisting of ten days of training (5 hours/day), with a minimum of three hours dedicated to speech and language rehabilitation with additional physical therapy. The program includes both individual treatment, group therapy and computer-based therapy. The therapy is individually set up after the participant's goals together with the team including SLPs, physiotherapists and a board-certified neurologist and/or specialist in rehabilitation medicine. The goals are set by the participants, family members and clinicians the first day of the program. The participant and their significant other are offered education with the aim to enhance the knowledge on communication, the key concepts of neuroplasticity and other functions and strategies important in everyday life. The treatment methods being used are evidence-based and/or widely used multimodal programs covering the need for extensive training programs targeting both impairment-based therapy and functional communication. The specific questions are: Does ten days of with an intensive comprehensive aphasia/AOS program result in any clinical significant improvements in speech and/or language function and other cognitive skills for participants with chronic aphasia and/or apraxia of speech? Does the intensive intervention have any effect on the quality of everyday life concerning speech and language functions, activity and communicative participation for people with chronic aphasia and apraxia of speech? Can functional and anatomical brain changes be detected following ten days of intensive speech and language intervention for these participants?
- Conditions
- Aphasia, Apraxia of Speech, Dysarthria
- Being tested
- Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech
- Keywords
- Intensive Aphasia Rehabilitation, Intensive Apraxia of Speech Rehabilitation, Neuroplasticity
- Medical subject headings
- Aphasia, Apraxias, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Intensive Rehabilitation of Aphasia and Apraxia of SpeechBehavioural
Intensive Comprehensive Aphasia (ICAP) and Apraxia of Speech Program
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA) | Experimental | A minimum of 3 hour speech-language training daily during 10 days. Receives: Behavioral: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Aphasia Test (CAT) language battery, in pilot Swedish test A-ning.
Comprehension of spoken language: minimum score 0, maximum score 66; Comprehension of written langugage: minimum score 0, maximum score 62; Repetition: minimum score 0, maximum score 74; Naming: minimum score 0, maximum score no limit; Reading: minimum score 0, maximum score 70; Writing: minimum score 0, maximum score 76. Higher scores mean better outcome in language functions.
Measured: Changes from baseline in language battery scores at 2 and 18 weeks.
Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)
Minimum score 0, maximum score 52. Lower scores mean better outcome in speech functions.
Measured: Changes from baseline scores at 2 and 18 weeks.
Communication Outcome After Stroke (COAST)
Minimum score 0, maximum score 100. Higher scores mean better outcome in communication.
Measured: Changes from baseline scores at 2 and 18 weeks.
Goal Attainment Scaling (GAS), International Classification of Functioning, Disability and Health (ICF). Aphasia adapted GAS scales for self-evaluation of communication functions, participation and activity.
Minimum score -2, maximum score +2. Higher scores mean better outcome in quality of life.
Measured: Changes from baseline at week 18.
Secondary outcomes (4)
Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)
Minimum score 0, maximum score 50. Higher scores mean better outcome in cognition.
Measured: Changes from baseline at week 2
Boston Naming Test (BNT)
Minimum score 0, maximum score 60. Higher scores mean better outcome in naming ability.
Measured: Changes from baseline at week 2 and week 18.
Protocol for Apraxia of Speech (TAX)
Minimum score 0, maximum score 30. Lower scores mean mean better outcome in speech functions and non verbal oral apraxia.
Measured: Changes from baseline at week 2 and week 18.
Comprehensive Aphasia Test (CAT), subtest cognitive screening
Minimum score 0, maximum score 38. Higher scores mean better outcome in cognitive functions.
Measured: Changes from baseline in Comprehensive Aphasia Test cognitive screening scores at 2 and 18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start2 Feb 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Principal investigator, Ellika Schalling, Karolinska Institutet
- Investigators
- Ellika Schalling, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604444
- Sponsor's protocol ID
- 2016/1651-31
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2020
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data (IPD) that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Intensive Speech and Language Rehabilitation Regarding Neuroplasticity, Speech, Language, Communication Skills and Quality of Life for People With Acquired Aphasia and/or Apraxia of Speech in the Chronic Phase
- ClinicalTrials.gov ID
- NCT04604444
- Acronym / sponsor ID
- 2016/1651-31
- Conditions
- Aphasia, Apraxia of Speech, Dysarthria
- Keywords
- Intensive Aphasia Rehabilitation, Intensive Apraxia of Speech Rehabilitation, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to investigate the short- and long-term effects of two weeks of intensive speech-language pathology intervention with additional physiotherapy, on aphasia and apraxia of speech (AOS) and their neural correlates in thirty persons with chronic stroke. Changes are studied following intensive treatment of aphasia and AOS with standardised speech-language testing and testing of communication and with voxel-based morphometry (VBM) analysis and resting state functional connectivity (rsFC).
Detailed description
This study explores structural and functional brain changes in relation to effects on speech, language, communication and quality of life following an intensive speech-language program with additional physiotherapy for persons with chronic aphasia and/or apraxia of speech. The participants are consecutively recruited from a rehabilitation centre providing intensive treatment for chronic conditions following stroke or other neurological injuries. The speech-language pathologists (SLPs) involved in the rehabilitation programs perform the testing directly before and after intensive intervention with an additional follow up after 16 weeks (+-2) with testing of speech-language, communication and quality of life. The SLPs have more than five years of experience of working with aphasia and are specialised in working with intensive treatment, they have acquired in-depth knowledge on how to evaluate and treat aphasia and apraxia of speech in lectures and workshops. The test procedure is recorded with camcorder and voice recorder to provide the opportunity to access data retrospectively and to minimize bias by including an external SLP who makes a second blinded evaluation on randomized participants' performance in ASRS, BNT and CAT by studying the video and voice material. Structural and functional neuroplasticity is also investigated with voxel-based morphometry (VBM) analysis, resting state functional connectivity (rsFC) in domain-specific (language processing) and domain-general (executive and attention processing). This intensive neuro-rehabilitation program for speech and language deficits named Multimodal Intensive Rehabilitation for Aphasia and Apraxia of Speech (MIRAA) is defined as an ICAP (Intensive Comprehensive Aphasia Program) with focus on both speech and language function and communicative activity and participation. The program is intensive: consisting of ten days of training (5 hours/day), with a minimum of three hours dedicated to speech and language rehabilitation with additional physical therapy. The program includes both individual treatment, group therapy and computer-based therapy. The therapy is individually set up after the participant's goals together with the team including SLPs, physiotherapists and a board-certified neurologist and/or specialist in rehabilitation medicine. The goals are set by the participants, family members and clinicians the first day of the program. The participant and their significant other are offered education with the aim to enhance the knowledge on communication, the key concepts of neuroplasticity and other functions and strategies important in everyday life. The treatment methods being used are evidence-based and/or widely used multimodal programs covering the need for extensive training programs targeting both impairment-based therapy and functional communication. The specific questions are: Does ten days of with an intensive comprehensive aphasia/AOS program result in any clinical significant improvements in speech and/or language function and other cognitive skills for participants with chronic aphasia and/or apraxia of speech? Does the intensive intervention have any effect on the quality of everyday life concerning speech and language functions, activity and communicative participation for people with chronic aphasia and apraxia of speech? Can functional and anatomical brain changes be detected following ten days of intensive speech and language intervention for these participants?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA) | Experimental | Behavioral: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of SpeechA minimum of 3 hour speech-language training daily during 10 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aphasia 7 months post stroke diagnosed by SLP
- Apraxia of Speech 7 months post stroke diagnosed by SLP
Key exclusion criteria (5 listed)
- Dementia
- Severe loss of sight
- Severe loss of hearing
- Metal implants (preventing fMRI)
- Claustrophobia (preventing fMRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Intensive Rehabilitation of Aphasia and Apraxia of SpeechIntensive Comprehensive Aphasia (ICAP) and Apraxia of Speech Program | Behavioural | Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA) |
Primary outcome
Comprehensive Aphasia Test (CAT) language battery, in pilot Swedish test A-ning.
Time frame: Changes from baseline in language battery scores at 2 and 18 weeks.
Comprehension of spoken language: minimum score 0, maximum score 66; Comprehension of written langugage: minimum score 0, maximum score 62; Repetition: minimum score 0, maximum score 74; Naming: minimum score 0, maximum score no limit; Reading: minimum score 0, maximum score 70; Writing: minimum score 0, maximum score 76. Higher scores mean better outcome in language functions.
Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)
Time frame: Changes from baseline scores at 2 and 18 weeks.
Minimum score 0, maximum score 52. Lower scores mean better outcome in speech functions.
Communication Outcome After Stroke (COAST)
Time frame: Changes from baseline scores at 2 and 18 weeks.
Minimum score 0, maximum score 100. Higher scores mean better outcome in communication.
Goal Attainment Scaling (GAS), International Classification of Functioning, Disability and Health (ICF). Aphasia adapted GAS scales for self-evaluation of communication functions, participation and activity.
Time frame: Changes from baseline at week 18.
Minimum score -2, maximum score +2. Higher scores mean better outcome in quality of life.
4 secondary outcomes
Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)
Time frame: Changes from baseline at week 2
Boston Naming Test (BNT)
Time frame: Changes from baseline at week 2 and week 18.
Protocol for Apraxia of Speech (TAX)
Time frame: Changes from baseline at week 2 and week 18.
Comprehensive Aphasia Test (CAT), subtest cognitive screening
Time frame: Changes from baseline in Comprehensive Aphasia Test cognitive screening scores at 2 and 18 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. All individual patient data (IPD) that underlie results in a publication.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellika Schalling, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech in people with Aphasia and Apraxia of Speech, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marika J Schütz, Ph.D student (0046737570430, marika.schutz@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Aphasia Test (CAT) language battery, in pilot Swedish test A-ning. (time frame: Changes from baseline in language battery scores at 2 and 18 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.