Clinical trial NCT04604444: 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
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia
Apraxia of Speech
Dysarthria
Keywords: Intensive Aphasia Rehabilitation
Intensive Apraxia of Speech Rehabilitation
Neuroplasticity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2020-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?

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)

Primary outcomes:
measure: Comprehensive Aphasia Test (CAT) language battery, in pilot Swedish test A-ning.
timeFrame: Changes from baseline in language battery scores at 2 and 18 weeks.
measure: Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)
timeFrame: Changes from baseline scores at 2 and 18 weeks.
measure: Communication Outcome After Stroke (COAST)
timeFrame: Changes from baseline scores at 2 and 18 weeks.
measure: 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.
timeFrame: Changes from baseline at week 18.
Secondary outcomes:
measure: Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)
timeFrame: Changes from baseline at week 2
measure: Boston Naming Test (BNT)
timeFrame: Changes from baseline at week 2 and week 18.
measure: Protocol for Apraxia of Speech (TAX)
timeFrame: Changes from baseline at week 2 and week 18.
measure: Comprehensive Aphasia Test (CAT), subtest cognitive screening
timeFrame: Changes from baseline in Comprehensive Aphasia Test cognitive screening scores at 2 and 18 weeks.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala Universitet
Study officials:
affiliation: Uppsala University
name: Ellika Schalling, Professor
role: PRINCIPAL_INVESTIGATOR
References: