MIRAA - A National Study on Intensive Rehabilitation of Aphasia and Apraxia of Speech Following Stroke
Phase: NA
Conditions: Aphasia, Apraxia of Speech, Stroke
Sponsor: Karolinska Institutet

MIRAA – implementation of intensive rehabilitation  
of aphasia and/or apraxia of speech in Swedish healthcare 
 
Interventional Study Protocol 
NCT ID: 
DATE: 2021-06-29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Interventional Study Protocol 
 
1. STUDY IDENTIFICATION  
Unique Protocol Identification Number:  2020-07182 
Brief Title: MIRAA – implementation of intensive rehabilitation of aphasia and/or apraxia of 
speech in Swedish healthcare 
Official Title: MIRAA – A national study on intensive rehabilitation of aphasia and apraxia 
of speech following stroke 
 
2. STUDY STATUS 
Study Type: Interventional 
Record Verification: April 2021   
Overall Status: Recruiting 
Study Start: March 10, 2021 [Actual] 
Primary Completion: December, 2022 [Anticipated] 
Study Completion: December, 2024 [Anticipated] 
 
3. SPONSORS/COLLABORATORS 
Sponsor: Karolinska Institutet   
Responsible Party: Principal Investigator 
Investigator: Ellika Schalling [eschalling] 
Official Title: Associate professor, Speech Language Pathologist 
Affiliation: Karolinska Institutet 
 
4. OVERSIGHT 
Studies a U.S. FDA-regulated Drug:  No   
Studies a U.S. FDA-regulated Device: No   
Device Product Not Approved or Cleared by U.S. FDA: No   
U.S Food and Drug Administration IND or IDE: No 
HUMAN SUBJECTS REVIEW  
 
Human subjects Protection Review Board Status: Submitted, approved 
 
Board Approval Number: 2020-07182 
Board Name: Swedish Ethical Review Authority 
Board Affiliation: Etikprövningsmyndigheten 

Phone: +46104750800   Email: registrator@etikprovning.se 
Address: Box 2110, 750 02 Uppsala, Sweden 
Data Monitoring: Yes 
FDA Regulated Intervention: No   
Section 801 Clinical Trial: No 
 
5. STUDY DESCRIPTION 
Brief 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. 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 healthcare according to the 
updated national guidelines from the Swedish National Board of Health and Welfare 
(Socialstyrelsen, 2018).   
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 (Afasiförbundet, 
2015). People with aphasia are seldom offered long-term treatment and intensive therapy is 
rarely offered (Blom Johansson, Carlsson et al., 2011; Palmquist, 2018). 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. ”It is not completely clear in which 
phase after stroke the intensive treatment should be offered but it seems more adequate in the 
sub-acute or chronic phase since a number people will not be able to participate in intensive 
treatment in the acute phase.” (Socialstyrelsen, National guidelines for stroke care, p. 41–42).   
 
Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech, MIRAA, is a 
modified 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. 
     The SLPs participating in the study 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?    
 
Following clinics participate in the study:  
• Aleris Rehab Station, Stockholm 
• 
Dalen, Capio Rehab, Stockholm 
• 
Farsta logopedmottagning, SLSO, Stockholm 
• 
Fysrehab, Lidköping 
• 
Logopedmottagningen Helsingborg och Ängelholm 
• 
Logopedienheten, Södra Älvsborgs sjukhus, Borås 
• 
Logopedkliniken, Danderyds sjukhus, Stockholm 
• 
Logopedbyrån Dynamica AB, Stockholm, Gustavsberg och Södertälje 
• 
Neurologimottagningen, Skånes universitetssjukhus, Lund 

• 
Neurorehab, Vrinnevisjukhuset, Norrköping 
• 
Närhälsan Gamlestadstorgets rehab, Göteborg 
• 
Närhälsan Gibraltar rehabmottagning, Göteborg 
• 
Närhälsan Angered, Rehabmottagning, Göteborg 
• 
Närhälsan Frölunda Rehabmottagning, Göteborg 
• 
Olivia Rehabilitering, Danderyd  
• 
Rehab City Lidingö, Stockholms Läns sjukhusområde 
• 
Rehabiliteringscentrum, region Jönköping 
• 
Rehabenheten, Sjukhusen i väster, Göteborg och Kungälv 
• 
VO Neurologi, Skånes universitetssjukhus, Lund 
• 
Sävedalen rehabmottagning, Partille 
• 
Vällingby logopedmottagning, SLSO Västra, Stockholm 
• 
Specialistrehabiliteringsenheten, Uppsala 
• 
Rehabenheten, Kliniken för medicin och geriatrik, Karlskoga  
 
6. CONDITIONS AND KEYWORDS  
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study: 
1. Aphasia 
2. Apraxia of Speech 
 
 
Keywords:  
1. Intensive Rehabilitation 
2. Neuroplasticity  
3. Implementation in healthcare  
4. Stroke guidelines 
5. ICAP (Intensive Comprehensive Aphasia Program) 
6. MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech) 
 
7. STUDY DESIGN (INTERVENTIONAL)  
Primary Purpose: Treatment 
Study Phase: N/A  
Interventional Study Model: Parallell  
Model Description: Cluster randomized clinical trial with two parallel arms.    

Number of Arms: 2 
Masking: Investigator 
Masking description: Block randomized sealed envelopes handled by external coordinator. 
Allocation:  Randomized 
Enrollment: 70 participants with aphasia and/or AOS [Anticipated] 
 
8. ARMS, GROUPS, AND INTERVENTIONS  
Arm 1:  Direct intervention Arm Type: Experimental  
Arm Title: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech (MIRAA) 
Arm description: Goal level 60 hours of intensive treatment during 6 weeks. Intensive 
treatment of aphasia and AOS in ICAP-format (MIRAA). 
Arm 2:  Control Arm Type: No Intervention  
Arm Title: Waiting group 
Arm description: 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. 
 
9. OUTCOME MEASURES  
Primary Outcome Measures 
1. Evaluation of training, questionnaire to participating SLPs  
Minimum score 0, maximum score 12. Higher scores mean better outcome on satisfaction 
with intensive training and effects on speech, language and functional communication. 
[Time Frame: Directly after intensive treatment]  
 
2. 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. 
[Time Frame: Directly after intensive treatment]  
Secondary Outcome Measures 
3. 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. [Time Frame: Changes from baseline in language battery scores at 6 and 16 (+-2) 
weeks.]  
 
 

4. Boston Naming Test (BNT)  
Minimum score 0, maximum score 60. Higher scores mean better outcome in naming ability. 
[Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.]  
 
5. 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. 
[Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.]  
 
6. Protocol for Apraxia of Speech (TAX)  
Minimum score 0, maximum score 30. Lower scores mean better outcome in speech functions 
and non-verbal oral apraxia. [Time Frame: Changes from baseline scores at 6 and 16 (+-2) 
weeks.]  
 
7. Comprehensive Aphasia Test (CAT), subtest cognitive screening  
Minimum score 0, maximum score 38. Higher scores mean better outcome in cognitive 
functions. [Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.]  
 
8. Communicative Effectiveness Index (CETI)  
Minimum score 0, maximum score 100. Higher scores mean better outcome in 
communicative effectiveness. [Time Frame: Changes from baseline scores at 6 and 16 (+-2) 
weeks.]  
 
9. General Health Questionnaire 12 questions (GHQ-12)  
Minimum score 0, maximum score 36. Lower scores mean mean better outcome in general 
health. [Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.]  
 
10. ELIGIBILITY  
Sex/Gender: 
Sex: All 
Gender Based: No   
Minimum Age: 18  
Unit of time: Years   
Maximum Age: No limit  
Unit of time: Years 
Accepts Healthy Volunteers: No   
Eligibility Criteria:  
Inclusion Criteria: 
• 
Aphasia 3 months post stroke diagnosed by SLP 
• 
Apraxia of Speech 3 months post stroke diagnosed by SLP 
• 
Being able to participate in rehabilitation in Swedish (not in need of translator to take 
part in treatment). 
 
 

Exclusion Criteria: 
• 
Advanced cognitive decline 
• 
Severe visual impairment  
• 
Severe hearing-impairment 
 
11. CONTACTS, LOCATIONS, AND INVESTIGATOR INFORMATION  
Central Contact Person: Marika J Schütz, Ph.D student 
Telephone: 0046737570430 
Email: marika.schutz@ki.se   
Study Officials: Ellika Schalling, Associate professor, SLP 
Official’s Role: Study Principal Investigator 
Facility information:  
Facility name: Karolinska Institutet, CLINTEC, Division of Speech and Language 
Pathology, F67, Karolinska University Hospital, Huddinge 
City: Stockholm 
ZIP/Postal Code: 141 86 
Individual Site Status: Recruiting  
Facility Contact:  
Name: Marika Schütz 
Degree: Doctoral student 
Phone: 0046737570430 
Email: marika.schutz@ki.se 
 
12. INDIVIDUAL PARTICIPANT DATA (IPD) SHARING STATEMENT  
Plan to Share IPD: Yes, all individual patient data (IPD) that underlie results in a 
publication. 
Supporting Information:  
Study Protocol 
Statistical Analysis Plan (SAP) 
Informed Consent Form (ICF) 
Time Frame: 2021-2031 
Access Criteria: Swedish National Data Service open source  
http://snd.gu.se