AphasiaMIRAANCT04957225
MIRAA - Implementation of Intensive Rehabilitation of Aphasia and/or Apraxia of Speech in Swedish Healthcare
A study testing MIRAA (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
Positive outcomes have been shown following intensive treatment of speech and/or language impairment post stroke, but how to design intensive treatment programs to achieve optimal recovery and neuroplasticity changes needs to be further researched. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Apraxia of Speech, Stroke
- What is being tested?
- MIRAA (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
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 10 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aphasia minimum 3 months post stroke
- Apraxia of Speech minimum 3 months post stroke
- Being able to participate in rehabilitation in Swedish (not in need of translator to partake).
Who cannot join
- Severe loss of sight
- Severe loss of hearing
- Severe cognitive decline
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, CLINTEC, Division of Speech and Language Pathology, F67, Karolinska University Hospital, Huddinge
Stockholm, 141 86
About this study
Official title: MIRAA - A National Study on Intensive Rehabilitation of Aphasia and Apraxia of Speech Following Stroke
Positive outcomes have been shown following intensive treatment of speech and/or language impairment post stroke, but how to design intensive treatment programs to achieve optimal recovery and neuroplasticity changes needs to be further researched. The purpose of the MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech) project is to study feasibility of intensive intervention for acquired aphasia and apraxia of speech (AOS) after stroke in the regular Swedish health-care according to the updated national guidelines from the Swedish National Board of Health and Welfare.
Read the detailed description
According to the Swedish National Board of Health and Welfare's guidelines for stroke care, persons with aphasia shall be offered intensive rehabilitation by speech-language pathologists. The aphasia rehabilitation is however sparse and unevenly distributed over the country as reported by the Swedish Aphasia Foundation. People with aphasia are seldom offered long-term treatment and intensive therapy is rarely offered. Intensive treatment is defined as at least 4h/week by the National Board of Health and Welfare, but higher intensity can be beneficial if tolerated by the patient.
Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech, MIRAA, is a modified Intensive Comprehensive Aphasia Program (ICAP) intervention program developed in the applicant's research group. MIRAA consists of a selection of evidence-based and/or well-established methods for speech and language rehabilitation as well as computer training. The training is both individual and group based, including communication between participants to promote transfer to real-life situations. Rehabilitation is based on principles that have been shown to promote neuroplasticity changes, such as high training intensity and multiple repetitions of tasks, for learning and relearning after brain injury. The intervention is goal-driven and individualized for high saliency, with focus on each participant's difficulties with language, speech and communication.
Speech and Language Pathologists (SLPs) all over Sweden working with aphasia and/or AOS following stroke are offered to participate in the study. At the time of recruitment, SLPs are invited to respond to a questionnaire about their current practice. SLPs accepting to participate are offered a 2-day workshop and recurring sessions containing introduction to and training in the MIRAA program as well as information about the logistics of the study.
42 SLPs from 23 clinics over the country participate in the study. The SLPs recruit participants with aphasia/AOS from their waiting and offer them a six-week MIRAA rehabilitation program consisting of a combination of individual treatment and group session and computer-assisted/homework training, with the goal level of 60 hours. The content of the program is individually adapted to clinics and participants. Participation in the study is consecutively offered to all individuals with speech language impairment post stroke that meet the inclusion criteria.
Following administration of the MIRAA-program including pre- and post-testing, participating SLPs will complete a questionnaire on their experiences of delivering the intensive intervention and factors hindering and facilitating implementation. Participants with aphasia/AOS and their next of kin will also provide information about their experiences through questionnaires and semi structured interviews, focus groups interviews and participant observations.
All participants are tested pre- post and at follow-up by a speech and language pathologist. Behavioral tests consist of quantitative measurements of speech, language, communication, cognition and quality of life. Part of the testing (TAX and CAT informative speech) is video- recorded for analysis after testing.
Background data are obtained noting sex, age, handedness, education level, language history aphasia type and severity and AOS, time since onset, mental fatigue, social life, number of strokes and earlier intensive rehabilitation at the time of the first assessment.
A subgroup of participants and SLPs from five clinics distributed over varying types of clinics reflecting the diversity among the clinics (inpatient care, primary care) take part in semi-structured interviews based on interview guides combined with focus group interviews and participant observations during one day of the last week of the intensive program focusing on facilitating and hindering factors for complying with an intensive intervention program like MIRAA.
A group consisting of SLPs not being able to participate in the study will form a focus group and discuss the specific factors hindering participation in the study in their respective settings.
The primary aim of this project is to explore the feasibility for national implementation of an intensive comprehensive intervention program for aphasia and AOS following stroke (MIRAA) in Swedish health care.
- What are facilitating or hindering factors for SLPs and their patients in the subacute and chronic phase post stroke with aphasia and/or AOS to comply with an intensive intervention program like MIRAA?
- How do participants, next of kin and SLPs experience intensive training in terms of effects and satisfaction with the program and with the implementation?
A secondary aim is to examine whether short-term and / or long-term effects on language, speech, communication and quality of life after intensive rehabilitation can be demonstrated.
- Can treatment effects regarding speech and/or language be detected when comparing the control group with the intervention group after six weeks of intensive intervention?
- Can treatment effects regarding communication and quality of life be detected when comparing the control group with the intervention group after six weeks of intensive intervention?
- Can long-term treatment effects on speech, language, communication and quality of life four months post intervention be detected?
- Conditions
- Aphasia, Apraxia of Speech, Stroke
- Being tested
- MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)
- Keywords
- Intensive rehabilitation, Neuroplasticity, Implementation in healthcare, Stroke guidelines, ICAP, MIRAA
- Medical subject headings
- Aphasia, Apraxias, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)Behavioural
Also called Modified ICAP (Intensive Comprehensive Aphasia Program)
Multimodal intensive treatment of aphasia and AOS
| Study group | Role | What they receive |
|---|---|---|
| Direct intervention | Experimental | Goal level 60 hours of intensive treatment during 6 weeks. Intensive treatment of aphasia and AOS in ICAP-format (MIRAA). Receives: Behavioral: MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech) |
| Waiting group | No intervention | No intervention during 6 weeks, testing directly before and after the waiting period. After the waiting period the participants receives the same intervention as the direct intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of training, questionnaire to participating Speech and Language Pathologists
Minimum score 0, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.
Measured: Directly after intensive treatment
Evaluation of training, questionnaire to participants
Minimum score 3, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.
Measured: Directly after intensive treatment
Secondary outcomes (7)
Comprehensive Aphasia Test (CAT)
Comprehensive Aphasia Test (CAT) language battery. Comprehension of spoken language: minimum score 0, maximum score 66; Comprehension of written language: 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 6 and 16 (+-2) weeks.
Boston Naming Test (BNT)
Minimum score 0, maximum score 60. Higher scores mean better outcome in naming ability.
Measured: Changes from baseline scores at 6 and 16 (+-2) 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: Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
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 scores at 6 and 16 (+-2) weeks.
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 scores at 6 and 16 (+-2) weeks.
Communicative Effectiveness Index (CETI)
Minimum score 0, maximum score 100. Higher scores mean better outcome in communicative effectiveness.
Measured: Changes from baseline scores at 6 and 16 (+-2) weeks.
General Health Questionnaire 12 questions (GHQ-12)
Minimum score 0, maximum score 36. Lower scores mean mean better outcome in general health.
Measured: Changes from baseline scores at 6 and 16 (+-2) weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start10 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized clinical trial with two parallel arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellika Schalling, Karolinska Institutet
- Investigators
- Ellika Schalling, Ph.D, SLP, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957225
- Sponsor's protocol ID
- 2020-07182
- Acronym
- MIRAA
- Status last verified
- Mar 2023
- First submitted
- 21 Jun 2021
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRAA - A National Study on Intensive Rehabilitation of Aphasia and Apraxia of Speech Following Stroke
- ClinicalTrials.gov ID
- NCT04957225
- Acronym / sponsor ID
- MIRAA / 2020-07182
- Conditions
- Aphasia, Apraxia of Speech, Stroke
- Keywords
- Intensive rehabilitation, Neuroplasticity, Implementation in healthcare, Stroke guidelines, ICAP, MIRAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Jul 2021 (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.
Positive outcomes have been shown following intensive treatment of speech and/or language impairment post stroke, but how to design intensive treatment programs to achieve optimal recovery and neuroplasticity changes needs to be further researched. The purpose of the MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech) project is to study feasibility of intensive intervention for acquired aphasia and apraxia of speech (AOS) after stroke in the regular Swedish health-care according to the updated national guidelines from the Swedish National Board of Health and Welfare.
Detailed description
According to the Swedish National Board of Health and Welfare's guidelines for stroke care, persons with aphasia shall be offered intensive rehabilitation by speech-language pathologists. The aphasia rehabilitation is however sparse and unevenly distributed over the country as reported by the Swedish Aphasia Foundation. People with aphasia are seldom offered long-term treatment and intensive therapy is rarely offered. Intensive treatment is defined as at least 4h/week by the National Board of Health and Welfare, but higher intensity can be beneficial if tolerated by the patient.
Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech, MIRAA, is a modified Intensive Comprehensive Aphasia Program (ICAP) intervention program developed in the applicant's research group. MIRAA consists of a selection of evidence-based and/or well-established methods for speech and language rehabilitation as well as computer training. The training is both individual and group based, including communication between participants to promote transfer to real-life situations. Rehabilitation is based on principles that have been shown to promote neuroplasticity changes, such as high training intensity and multiple repetitions of tasks, for learning and relearning after brain injury. The intervention is goal-driven and individualized for high saliency, with focus on each participant's difficulties with language, speech and communication.
Speech and Language Pathologists (SLPs) all over Sweden working with aphasia and/or AOS following stroke are offered to participate in the study. At the time of recruitment, SLPs are invited to respond to a questionnaire about their current practice. SLPs accepting to participate are offered a 2-day workshop and recurring sessions containing introduction to and training in the MIRAA program as well as information about the logistics of the study.
42 SLPs from 23 clinics over the country participate in the study. The SLPs recruit participants with aphasia/AOS from their waiting and offer them a six-week MIRAA rehabilitation program consisting of a combination of individual treatment and group session and computer-assisted/homework training, with the goal level of 60 hours. The content of the program is individually adapted to clinics and participants. Participation in the study is consecutively offered to all individuals with speech language impairment post stroke that meet the inclusion criteria.
Following administration of the MIRAA-program including pre- and post-testing, participating SLPs will complete a questionnaire on their experiences of delivering the intensive intervention and factors hindering and facilitating implementation. Participants with aphasia/AOS and their next of kin will also provide information about their experiences through questionnaires and semi structured interviews, focus groups interviews and participant observations.
All participants are tested pre- post and at follow-up by a speech and language pathologist. Behavioral tests consist of quantitative measurements of speech, language, communication, cognition and quality of life. Part of the testing (TAX and CAT informative speech) is video- recorded for analysis after testing.
Background data are obtained noting sex, age, handedness, education level, language history aphasia type and severity and AOS, time since onset, mental fatigue, social life, number of strokes and earlier intensive rehabilitation at the time of the first assessment.
A subgroup of participants and SLPs from five clinics distributed over varying types of clinics reflecting the diversity among the clinics (inpatient care, primary care) take part in semi-structured interviews based on interview guides combined with focus group interviews and participant observations during one day of the last week of the intensive program focusing on facilitating and hindering factors for complying with an intensive intervention program like MIRAA.
A group consisting of SLPs not being able to participate in the study will form a focus group and discuss the specific factors hindering participation in the study in their respective settings.
The primary aim of this project is to explore the feasibility for national implementation of an intensive comprehensive intervention program for aphasia and AOS following stroke (MIRAA) in Swedish health care.
- What are facilitating or hindering factors for SLPs and their patients in the subacute and chronic phase post stroke with aphasia and/or AOS to comply with an intensive intervention program like MIRAA?
- How do participants, next of kin and SLPs experience intensive training in terms of effects and satisfaction with the program and with the implementation?
A secondary aim is to examine whether short-term and / or long-term effects on language, speech, communication and quality of life after intensive rehabilitation can be demonstrated.
- Can treatment effects regarding speech and/or language be detected when comparing the control group with the intervention group after six weeks of intensive intervention?
- Can treatment effects regarding communication and quality of life be detected when comparing the control group with the intervention group after six weeks of intensive intervention?
- Can long-term treatment effects on speech, language, communication and quality of life four months post intervention be detected?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized clinical trial with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Direct intervention | Experimental | Behavioral: MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)Goal level 60 hours of intensive treatment during 6 weeks. Intensive treatment of aphasia and AOS in ICAP-format (MIRAA). |
| Waiting group | No intervention | –No intervention during 6 weeks, testing directly before and after the waiting period. After the waiting period the participants receives the same intervention as the direct intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aphasia minimum 3 months post stroke
- Apraxia of Speech minimum 3 months post stroke
- Being able to participate in rehabilitation in Swedish (not in need of translator to partake).
Key exclusion criteria (3 listed)
- Severe loss of sight
- Severe loss of hearing
- Severe cognitive decline
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 |
|---|---|---|
| MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)Also: Modified ICAP (Intensive Comprehensive Aphasia Program)Multimodal intensive treatment of aphasia and AOS | Behavioural | Direct intervention |
Primary outcome
Evaluation of training, questionnaire to participating Speech and Language Pathologists
Time frame: Directly after intensive treatment
Minimum score 0, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.
Evaluation of training, questionnaire to participants
Time frame: Directly after intensive treatment
Minimum score 3, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.
7 secondary outcomes
Comprehensive Aphasia Test (CAT)
Time frame: Changes from baseline in language battery scores at 6 and 16 (+-2) weeks.
Boston Naming Test (BNT)
Time frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)
Time frame: Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
Protocol for Apraxia of Speech (TAX)
Time frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
Comprehensive Aphasia Test (CAT), subtest cognitive screening
Time frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
Communicative Effectiveness Index (CETI)
Time frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
General Health Questionnaire 12 questions (GHQ-12)
Time frame: Changes from baseline scores at 6 and 16 (+-2) weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- 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. This study is not recruiting at the moment.
Ellika Schalling, Ph.D, SLP principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRAA (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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of training, questionnaire to participating Speech and Language Pathologists (time frame: Directly after intensive treatment). The study lists 2 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 9 Mar 2023.