Changes in Neuroplasticity Following Intensive Rehabilitation of Aphasia and/or Apraxia of Speech
Primary Purpose
Aphasia, Apraxia of Speech, Dysarthria
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Intensive Aphasia Rehabilitation, Intensive Apraxia of Speech Rehabilitation, Neuroplasticity
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 loss of sight
- Severe loss of hearing
- Metal implants (preventing fMRI)
- Claustrophobia (preventing fMRI)
Sites / Locations
- Uppsala UniversitetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA)
Arm Description
A minimum of 3 hour speech-language training daily during 10 days.
Outcomes
Primary Outcome Measures
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.
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.
Communication Outcome After Stroke (COAST)
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.
Minimum score -2, maximum score +2. Higher scores mean better outcome in quality of life.
Secondary Outcome Measures
Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)
Minimum score 0, maximum score 50. Higher scores mean better outcome in cognition.
Boston Naming Test (BNT)
Minimum score 0, maximum score 60. Higher scores mean better outcome in naming ability.
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.
Comprehensive Aphasia Test (CAT), subtest cognitive screening
Minimum score 0, maximum score 38. Higher scores mean better outcome in cognitive functions.
Full Information
NCT ID
NCT04604444
First Posted
September 11, 2020
Last Updated
October 5, 2023
Sponsor
Karolinska Institutet
Collaborators
University of Malaga
1. Study Identification
Unique Protocol Identification Number
NCT04604444
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
University of Malaga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
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 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Apraxia of Speech, Dysarthria
Keywords
Intensive Aphasia Rehabilitation, Intensive Apraxia of Speech Rehabilitation, Neuroplasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA)
Arm Type
Experimental
Arm Description
A minimum of 3 hour speech-language training daily during 10 days.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech
Intervention Description
Intensive Comprehensive Aphasia (ICAP) and Apraxia of Speech Program
Primary Outcome Measure Information:
Title
Comprehensive Aphasia Test (CAT) language battery, in pilot Swedish test A-ning.
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 in language functions.
Time Frame
Changes from baseline in language battery scores at 2 and 18 weeks.
Title
Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)
Description
Minimum score 0, maximum score 52. Lower scores mean better outcome in speech functions.
Time Frame
Changes from baseline scores at 2 and 18 weeks.
Title
Communication Outcome After Stroke (COAST)
Description
Minimum score 0, maximum score 100. Higher scores mean better outcome in communication.
Time Frame
Changes from baseline scores at 2 and 18 weeks.
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.
Description
Minimum score -2, maximum score +2. Higher scores mean better outcome in quality of life.
Time Frame
Changes from baseline at week 18.
Secondary Outcome Measure Information:
Title
Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)
Description
Minimum score 0, maximum score 50. Higher scores mean better outcome in cognition.
Time Frame
Changes from baseline at week 2
Title
Boston Naming Test (BNT)
Description
Minimum score 0, maximum score 60. Higher scores mean better outcome in naming ability.
Time Frame
Changes from baseline at week 2 and week 18.
Title
Protocol for Apraxia of Speech (TAX)
Description
Minimum score 0, maximum score 30. Lower scores mean mean better outcome in speech functions and non verbal oral apraxia.
Time Frame
Changes from baseline at week 2 and week 18.
Title
Comprehensive Aphasia Test (CAT), subtest cognitive screening
Description
Minimum score 0, maximum score 38. Higher scores mean better outcome in cognitive functions.
Time Frame
Changes from baseline in Comprehensive Aphasia Test cognitive screening scores at 2 and 18 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 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 loss of sight
Severe loss of hearing
Metal implants (preventing fMRI)
Claustrophobia (preventing fMRI)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marika J Schütz, Ph.D student
Phone
0046737570430
Email
marika.schutz@uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellika Schalling, Professor
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala Universitet
City
Uppsala
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marika Schütz, Ph.D student
Phone
0046737570430
Email
marika.schutz@uu.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual patient data (IPD) that underlie results in a publication.
IPD Sharing Time Frame
2020-2030
IPD Sharing Access Criteria
Swedish National Data Service open source http://snd.gu.se/sv/dashboard/data-description/0a1f0ee0-454e-4d66-b43f-b235bfe821a6#publications
Learn more about this trial
Changes in Neuroplasticity Following Intensive Rehabilitation of Aphasia and/or Apraxia of Speech
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