MIRAA - Implementation of Intensive Rehabilitation of Aphasia and/or Apraxia of Speech in Swedish Healthcare

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT04957225
Collaborator
(none)
70
1
2
44.7
1.6

Study Details

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 health-care according to the updated national guidelines from the Swedish National Board of Health and Welfare.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)
N/A

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. People with aphasia are seldom offered long-term treatment and intensive therapy is rarely offered. 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.

Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech, MIRAA, is a modified Intensive Comprehensive Aphasia Program (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.

42 SLPs from 23 clinics over the country participate in the study. The SLPs 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?

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster randomized clinical trial with two parallel arms.Cluster randomized clinical trial with two parallel arms.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Block randomized sealed envelopes handled by external coordinator.
Primary Purpose:
Treatment
Official Title:
MIRAA - A National Study on Intensive Rehabilitation of Aphasia and Apraxia of Speech Following Stroke
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Direct intervention

Goal level 60 hours of intensive treatment during 6 weeks. Intensive treatment of aphasia and AOS in ICAP-format (MIRAA).

Behavioral: MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)
Multimodal intensive treatment of aphasia and AOS
Other Names:
  • Modified ICAP (Intensive Comprehensive Aphasia Program)
  • No Intervention: Waiting group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of training, questionnaire to participating Speech and Language Pathologists [Directly after intensive treatment]

      Minimum score 0, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.

    2. Evaluation of training, questionnaire to participants [Directly after intensive treatment]

      Minimum score 3, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.

    Secondary Outcome Measures

    1. Comprehensive Aphasia Test (CAT) [Changes from baseline in language battery scores at 6 and 16 (+-2) weeks.]

      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.

    2. Boston Naming Test (BNT) [Changes from baseline scores at 6 and 16 (+-2) weeks.]

      Minimum score 0, maximum score 60. Higher scores mean better outcome in naming ability.

    3. Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS) [Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.]

      Minimum score 0, maximum score 52. Lower scores mean better outcome in speech functions.

    4. Protocol for Apraxia of Speech (TAX) [Changes from baseline scores at 6 and 16 (+-2) weeks.]

      Minimum score 0, maximum score 30. Lower scores mean mean better outcome in speech functions and non verbal oral apraxia.

    5. Comprehensive Aphasia Test (CAT), subtest cognitive screening [Changes from baseline scores at 6 and 16 (+-2) weeks.]

      Minimum score 0, maximum score 38. Higher scores mean better outcome in cognitive functions.

    6. Communicative Effectiveness Index (CETI) [Changes from baseline scores at 6 and 16 (+-2) weeks.]

      Minimum score 0, maximum score 100. Higher scores mean better outcome in communicative effectiveness.

    7. General Health Questionnaire 12 questions (GHQ-12) [Changes from baseline scores at 6 and 16 (+-2) weeks.]

      Minimum score 0, maximum score 36. Lower scores mean mean better outcome in general health.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Aphasia minimum 3 months post stroke

    • Apraxia of Speech minimum 3 months post stroke

    • Being able to participate in rehabilitation in Swedish (not in need of translator to partake).

    Exclusion Criteria:
    • Severe loss of sight

    • Severe loss of hearing

    • Severe cognitive decline

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska Institutet, CLINTEC, Division of Speech and Language Pathology, F67, Karolinska University Hospital, Huddinge Stockholm Sweden 141 86

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Ellika Schalling, Ph.D, SLP, Karolinska Institutet

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ellika Schalling, Associate professor, Speech Language Pathologist, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT04957225
    Other Study ID Numbers:
    • 2020-07182
    First Posted:
    Jul 12, 2021
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ellika Schalling, Associate professor, Speech Language Pathologist, Karolinska Institutet
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2021