Motor Imagery for Treatment Enhancement and Efficacy in Persons With Apraxia of Speech

NCT06467136 | Recruiting

• 2 other identifiers: AWD000057141R21DC020548-01A1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of post-stroke apraxia of speech (AOS) requires frequent and ongoing practice with a speech-language pathologist to facilitate lasting behavioral change, which is costly and, therefore, inaccessible to many patients. Thus, there is a critical need to identify novel, cost-effective ways to supplement speech therapy to increase opportunities for practice and optimize treatment outcomes. Our long-term goal is to develop an effective, home-practice, computer-based, motor imagery protocol Motor Imagery for Treatment Enhancement and Efficacy (MI-TEE) which will serve as an adjunct to routine speech therapy to optimize treatment response in persons with AOS. The overall objectives of this application are to (i) evaluate the acceptability and feasibility of MI-TEE as a home practice program and (ii) determine the efficacy of MI-TEE with speech therapy, compared to speech therapy alone, in improving speech production in people with AOS. Our central hypothesis is that MI-TEE will be an accessible, feasible, and efficacious adjunct to speech therapy. To attain our objectives, the following specific aims will be pursued using two single-subject experimental designs with multiple baselines across participants (n=18): 1) Evaluate the acceptability and feasibility of MI-TEE as an adjunct to speech therapy for the rehabilitation of AOS; and 2) Compare the efficacy of adjunctive MI-TEE plus standard speech therapy to standard speech therapy alone. Under the first aim, observational data, surveys, and semi-structured interviews will be employed to assess the acceptability (perceived satisfaction, appropriateness, and intent to continue use) and feasibility (recruitment, retention, and intervention adherence rates) of MI-TEE. For the second aim, accuracy of articulation for trained words and untrained words (generalization) will be measured pre-treatment, repeatedly during the treatment phase, and post-treatment. Improvements in speech accuracy will be documented using a binary scoring system (correct/incorrect). Multilevel analyses will be used to address rate of acquisition, overall change, and response variation across participants.

Conditions

Apraxia, Oral; Apraxia of Speech

Keywords

Treatment of Apraxia of Speech; Home Practice for Apraxia of Speech; AOS; Apraxia of speech

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Participants will complete acceptability surveys and meet individually with a member of the research team to engage in semi-structured interviews.82 Acceptability data will include perceived satisfaction and appropriateness, experience with MI-TEE, and intent to continue use.

  Assessment of acceptability will occur after completion of the 8.3 week treatment program

• Recruitment feasibility

  Feasibility data will be collected by research staff throughout the study and will include recruitment feasibility, the percent of eligible individuals agreeing to participate in the MI-TEE program.

  Through study completion, up to 24 weeks.

• Adherence rates

  Feasibility data will be collected by research staff throughout the study and will include adherence rates, the participants ability to adhere to the MI-TEE protocol.

  Start of MI-TEE program to the end of the 8.3 week treatment program for each participant.

• Retention rate

  Feasibility data will be collected by research staff throughout the study and will include retention rates, the percent of participants who complete the entire MI-TEE program.

  Start of MI-TEE enrollment to the end of the 8.3 week treatment program for each participant.

• Rate of change

  The dependent variable is rate of change for accuracy of sound production in experimental words produced during probes.

  From enrollment to the end of maintenance at 10 weeks, total of up to 23 weeks.

Study Arms (2)

Condition 1

EXPERIMENTAL

Condition 1 will have three phases: (A) no treatment; (B) speech therapy alone; (C) speech therapy plus MI-TEE (the home practice program).

Behavioral: Sound production treatment; Behavioral: Motor Imagery Practice

Condition 2

EXPERIMENTAL

Condition 2 will include two phases: (A) no treatment; (C) speech therapy plus MI-TEE (the home practice program).

Behavioral: Sound production treatment; Behavioral: Motor Imagery Practice

Interventions

Sound production treatment BEHAVIORAL

Evidence based treatment for apraxia of speech, developed by Julie Wambaugh.

Also known as: SPT

Condition 1; Condition 2

Motor Imagery Practice BEHAVIORAL

Practice of target items using motor imagery during home practice

Condition 1; Condition 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18 and 90 yrs. old
• At least 6 months post left hemisphere stroke
• Demonstrate AOS
• Speak English as their primary language
• Pass a hearing screening at 35 dB HL at 500, 1K, and 2K Hz for at least one ear
• Normal or corrected to normal visual acuity

You may not qualify if:

• Unable to follow two-step commands and greater than moderate aphasia
• Moderate - severe dysarthria
• Untreated depression or other psychiatric illness
• Degenerative neurological illnesses
• Less than 3 on the MIQ-RS77
• Less than a 4 on 3/5 domains on the FACETS
• Less than a 23 on the Raven's Coloured Progressive Matrices
• Receive other speech therapy while participating in the study

Sponsors & Collaborators

• University of Central Florida: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Central Florida Innovation Rehabilitation Center

Orlando, Florida, 32826, United States

RECRUITING

MeSH Terms

Conditions

Apraxias

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren Bislick Wilson, Ph.D.

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Bislick Wilson, Ph.D.

CONTACT

407-823-4768; Lauren.Bislick@ucf.edu

Stephanie Eaton, MA

CONTACT

407-823-4768; Stephanie.Eaton@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant will be blind to study condition and time point
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Director UCF Aphasia House

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: December 11, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion. Available via supplemental materials in publications.
• Access Criteria: Access to peer-reviewed/published manuscripts

Locations

US (1)