An interventional study of Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech in Aphasia, Apraxia of Speech and Dysarthria, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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).
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?
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
A minimum of 3 hour speech-language training daily during 10 days.
Behavioral: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech
Intensive Comprehensive Aphasia (ICAP) and Apraxia of Speech Program
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Changes from baseline at week 18.
Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)
Minimum score 0, maximum score 50. Higher scores mean better outcome in cognition.
Time frame: Changes from baseline at week 2
Boston Naming Test (BNT)
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.
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.
Time frame: 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.
Time frame: Changes from baseline in Comprehensive Aphasia Test cognitive screening scores at 2 and 18 weeks.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual patient data (IPD) that underlie results in a publication.
Supporting information: Study protocol, Informed consent form, 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
Started Feb 2017 (actual). Primary completion is estimated for Dec 2026, 118 months after the start.
Of 183 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 118 months is above that.
Counting every sponsor, half of 185 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
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