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

NCT04957225 | Completed DMC

• 1 other identifier: 2020-07182
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Apraxia of Speech; Stroke

Keywords

Intensive rehabilitation; Neuroplasticity; Implementation in healthcare; Stroke guidelines; ICAP; MIRAA

Outcome Measures

Primary Outcomes (2)

• Evaluation of training, questionnaire to participating Speech and Language Pathologists

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

  Directly after intensive treatment

• Evaluation of training, questionnaire to participants

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

  Directly after intensive treatment

Secondary Outcomes (7)

• Comprehensive Aphasia Test (CAT)

  Changes from baseline in language battery scores at 6 and 16 (+-2) weeks.

• Boston Naming Test (BNT)

  Changes from baseline scores at 6 and 16 (+-2) weeks.

• Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)

  Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.

• Protocol for Apraxia of Speech (TAX)

  Changes from baseline scores at 6 and 16 (+-2) weeks.

• Comprehensive Aphasia Test (CAT), subtest cognitive screening

  Changes from baseline scores at 6 and 16 (+-2) weeks.

Study Arms (2)

Direct intervention

EXPERIMENTAL

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)

Waiting group

NO INTERVENTION

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.

Interventions

MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech) BEHAVIORAL

Multimodal intensive treatment of aphasia and AOS

Also known as: Modified ICAP (Intensive Comprehensive Aphasia Program)

Direct intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Severe loss of sight
• Severe loss of hearing
• Severe cognitive decline

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, CLINTEC, Division of Speech and Language Pathology, F67, Karolinska University Hospital, Huddinge

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Aphasia; Apraxias; Stroke

Interventions

GAT

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ellika Schalling, Ph.D, SLP

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block randomized sealed envelopes handled by external coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Speech Language Pathologist

Model Details: Cluster randomized clinical trial with two parallel arms.

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 12, 2021
• Study Start: March 10, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2021-2031
• Access Criteria: Swedish National Data Service open source

Locations

SE (1)