Changes in Neuroplasticity Following Intensive Rehabilitation of Aphasia and/or Apraxia of Speech

NCT04604444 | Recruiting DMC

• 1 other identifier: 2016/1651-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Aphasia; Apraxia of Speech; Dysarthria

Keywords

Intensive Aphasia Rehabilitation; Intensive Apraxia of Speech Rehabilitation; Neuroplasticity

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Changes from baseline at week 18.

Secondary Outcomes (4)

• Barrow Neurological Institute Screening for Higher Cerebral Function (BNIS)

  Changes from baseline at week 2

• Boston Naming Test (BNT)

  Changes from baseline at week 2 and week 18.

• Protocol for Apraxia of Speech (TAX)

  Changes from baseline at week 2 and week 18.

• Comprehensive Aphasia Test (CAT), subtest cognitive screening

  Changes from baseline in Comprehensive Aphasia Test cognitive screening scores at 2 and 18 weeks.

Study Arms (1)

Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA)

EXPERIMENTAL

A minimum of 3 hour speech-language training daily during 10 days.

Behavioral: Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech

Interventions

Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech BEHAVIORAL

Intensive Comprehensive Aphasia (ICAP) and Apraxia of Speech Program

Multimodal Intensive Rehabilitation of Aphasia/AOS (MIRAA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aphasia 7 months post stroke diagnosed by SLP
• Apraxia of Speech 7 months post stroke diagnosed by SLP

You may not qualify if:

• Dementia
• Severe loss of sight
• Severe loss of hearing
• Metal implants (preventing fMRI)
• Claustrophobia (preventing fMRI)

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Malaga: collaborator

Study Sites (1)

Uppsala Universitet

Uppsala, 141 86, Sweden

RECRUITING

MeSH Terms

Conditions

Aphasia; Apraxias; Dysarthria

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; Articulation Disorders

Study Officials

• Ellika Schalling, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marika J Schütz, Ph.D student

CONTACT

0046737570430; marika.schutz@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Speech Language Pathologist

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 27, 2020
• Study Start: February 2, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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

Locations

SE (1)