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
Phase: NA
Conditions: Aphasia, Apraxia of Speech, Dysarthria
Sponsor: Karolinska Institutet

Changes in Neuroplasticity Following Intensive Rehabilitation 
of Aphasia and/or Apraxia of Speech 
 
Interventional Study Protocol 
NCT ID: 
DATE: 2020-09-30 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Interventional Study Protocol 
 
1. STUDY IDENTIFICATION  
Unique Protocol Identification Number:  2016/1651-31 
Brief Title: Changes in Neuroplasticity Following Intensive Rehabilitation of Aphasia and/or 
Apraxia of Speech 
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 
 
2. STUDY STATUS 
Study Type: Interventional 
Record Verification: September 2020   
Overall Status: Recruiting 
Study Start: February 2, 2017 [Actual] 
Primary Completion: December 31, 2023 [Anticipated] 
Study Completion: July 31, 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 
Collaborators:  University of Malaga 
 
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: 2016/1651-31 

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: 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 assement of communication as well as 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 impairments 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 intensive intervention during ten days, with the MIRAA program result in any clinically 
significant improvements in speech and/or language functions and other cognitive skills for 
participants with chronic aphasia and/or apraxia of speech?  
Does the intensive intervention have an effect on the quality of everyday life related to 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?    
  
 
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 
3. Dysarthria  
Keywords:  
1. Intensive Aphasia Rehabilitation 
2. Intensive Apraxia of Speech Rehabilitation 
3. Neuroplasticity 
 

7. STUDY DESIGN (INTERVENTIONAL)  
Primary Purpose: Treatment 
Study Phase: N/A  
Interventional Study Model: Single Group  
Number of Arms: 1 
Masking:  
None (Open Label) 
Allocation:  N/A 
Enrollment: 30 [Anticipated] 
 
8. ARMS, GROUPS, AND INTERVENTIONS  
Arm 1:  Arm Type: Experimental:  
Arm Title: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech (MIRAA) 
Arm description: A minimum of 3 hours speech-language training daily during 10 days. 
Intervention 1: Intervention Type: Behavioural 
Intervention Name: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech 
(MIRAA) 
Intervention Description: Intensive Comprehensive Aphasia (ICAP) and Apraxia of Speech 
Program 
Arm/Interventional Cross-Reference: Only one arm (arm 1, intervention 1). 
 
9. OUTCOME MEASURES  
Primary Outcome Measures 
Outcome 1: Primary Outcome Measure: 
Title: Comprehensive Aphasia Test (CAT) language battery, in pilot Swedish test A-ning. 
Time Frame: Changes from baseline in Comprehensive Aphasia Test language battery scores 
at 2 and 18 weeks.  
Description: 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 for language functions.   
 
Outcome 2. Primary Outcome Measure: 
Title: Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS) 
Time Frame: Changes from baseline scores at 2 and 18 weeks. 

Description: Minimum score 0, maximum score 52. Lower scores mean better outcome for 
speech functions.   
 
Outcome 3. Primary Outcome Measure: 
Title: Communication Outcome After Stroke (COAST) 
Time Frame: Changes from baseline at scores 2 and 18 weeks. 
Description: Minimum score 0, maximum score 100. Higher scores mean better outcome for 
communication.   
 
Outcome 4. Primary Outcome Measures: 
Title: 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. 
Description: Minimum score -2, maximum score +2. Higher scores can mean better outcome 
for quality of life.  
 
Secondary Outcome Measures 
Outcome 5. Secondary Outcome Measure: 
Title: Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS) 
Time Frame: Changes from baseline at week 2. 
Description: Minimum score 0, maximum score 50. Higher scores mean better outcome for 
cognition. 
 
Outcome 6: Secondary Outcome Measure: 
Title: Boston Naming Test (BNT) 
Time Frame: Changes from baseline at week 2 and week 18. 
Description: Minimum score 0, maximum score 60. Higher scores mean better outcome for 
naming ability.  
 
Outcome 7. Secondary Outcome Measure: 
Title: Test for Apraxia of Speech (TAX) 
Time Frame: Changes from baseline at week 2 and week 18. 
Description: Minimum score 0, maximum score 30. Lower scores mean better outcome for 
speech functions and non-verbal oral apraxia.  
 
 

Outcome 8. Secondary Outcome Measure: 
Title: Comprehensive Aphasia Test (CAT), subtest cognitive screening 
Time Frame: Changes from baseline in Comprehensive Aphasia Test cognitive screening 
scores at 2 and 18 weeks.  
Description: Minimum score 0, maximum score 38. Higher scores mean better outcome for 
cognitive functions.   
 
10. ELIGIBILITY  
Sex/Gender: 
Sex: All 
Gender Based: No   
Minimum Age: 18  
Unit of time: Years   
Maximum Age: 75  
Unit of time: Years 
Accepts Healthy Volunteers: No   
Eligibility Criteria:  
Inclusion Criteria: 
• 
Aphasia 7 months post stroke diagnosed by SLP 
• 
Apraxia of Speech 7 months post stroke diagnosed by SLP 
Exclusion Criteria: 
• 
Dementia 
• 
Severe visual impairment  
• 
Severe hearing-impairment 
• 
Metal implants (preventing fMRI) 
• 
Claustrophobia (preventing fMRI) 
 
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, Ph.D, SLP 
Official’s Role: Study Principal Investigator 
Facility information:  

Facility name: Karolinska Institutet, CLINTEC, Enheten för logopedi, F67, Karolinska 
University Hospital, Huddinge 
City: Stockholm 
ZIP/Postal Code: 141 86 
Individual Site Status: Recruiting  
Facility Contact:  
Name: Marika Schütz 
Degree: Ph.D 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 
Informed Consent Form (ICF) 
Analytic Code 
Time Frame: 2020-2030 
Access Criteria: Swedish National Data Service open source 
http://snd.gu.se/sv/dashboard/data-description/0a1f0ee0-454e-4d66-b43f-
b235bfe821a6#publications