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临床试验/NCT06467136
NCT06467136招募中不适用

Motor Imagery for Treatment Enhancement and Efficacy (MI-TEE) in Persons With Apraxia of Speech

University of Central Florida2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
2
主要终点
Adherence rates

研究概览

简要总结

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.

详细描述

This R21 Proposal will employ a mixed-methods design in 18 individuals with apraxia of speech and mild-moderate co-occurring aphasia to examine two Aims:

Aim 1. Evaluate the acceptability and feasibility of MI-TEE as an adjunct to speech therapy for the rehabilitation of AOS. This Aim will Incorporate observational data, survey responses (self-report) and semi-structured interviews. Specifically, mixed quantitative and qualitative methods will be employed to assess the acceptability and feasibility of MI-TEE. Quantitative data will include observational data and results of survey responses. Qualitative data will include themes that emerge from open-ended survey items and semi-structured interviews. Assessment of acceptability will occur after completion of the 12-week treatment program. Participants will meet individually with a member of the research team to complete acceptability surveys and semi-structured interviews. Acceptability data will include perceived satisfaction, perceived appropriateness, and intent to continue use. Assessment of feasibility will determine the extent to which the treatment, including study design and procedures, is executed effectively. Feasibility data will be collected by research staff and will include recruitment feasibility (percent of eligible individuals agreeing to participate), retention rate, and adherence rates (ability of participants to adhere to MI-TEE).

Aim 2. Compare the efficacy of adjunctive MI-TEE to standard speech therapy (Sound Production Treatment) alone. This aim will employ a single subject experimental design (SSED) with multiple baselines across participants and probes across behaviors will be used to explore the effects of speech therapy alone compared to speech therapy with MI-TEE in 15 stroke survivors with AOS. The treatment design will include multiple phases: (A) no treatment; (B) speech therapy alone; (C) speech therapy plus MI-TEE. The first "A" will consist of pre-treatment baseline testing, while the second will consist of maintenance testing. Following baseline probes, treatment probes will be extended sequentially to each of the two lists of stimuli, which are described in the following section (Experimental Stimuli). Probing will continue throughout the treatment phases. After cessation of all treatment, follow-up probes will be conducted at 2, 6, and 10 weeks. Accuracy of articulation of two lists of experimental stimuli will be measured repeatedly via probes.

This proposal will include 18 adult (≥18 years of age) stroke patients. No subpopulation of adults with apraxia of speech and aphasia will be excluded (see Inclusion of Women and Minorities).

Potential participants will have had a left hemisphere stroke (documented by imaging with either CT or MRI) and be 6 months or more post-stroke, right handed, English as a primary language, high-school education or equivalent, between the ages of 18 and 90, pass a hearing screening at 35 dB hearing level (HL) at 500, 1K, and 2K Hz for at least one ear, and have normal or corrected to normal visual acuity as determined by a vision screen (Tumbling E eye chart).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

A research assistant will be blind to study condition and time point

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Adherence rates

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

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.

Acceptability

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

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.

Recruitment feasibility

时间窗: Through study completion, up to 24 weeks.

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.

Retention rate

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

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.

Rate of change

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Bislick Wilson

Associate Professor; Director UCF Aphasia House

University of Central Florida

研究点 (2)

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