MedPath

Speech Entrainment for Aphasia Recovery

Phase 2
Active, not recruiting
Conditions
Aphasia
Aphasia Non Fluent
Stroke
Interventions
Behavioral: SET (Speech Entrainment Therapy) 3 weeks
Behavioral: SET (Speech Entrainment Therapy) 4.5 weeks
Behavioral: SET (Speech Entrainment Therapy) 6 weeks
Other: No Therapy 6 Weeks
Registration Number
NCT04364854
Lead Sponsor
Medical University of South Carolina
Brief Summary

After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. The study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production.

Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SET (Speech Entrainment Therapy) 3 weeksSET (Speech Entrainment Therapy) 3 weeks-
SET (Speech Entrainment Therapy) 4.5 weeksSET (Speech Entrainment Therapy) 4.5 weeks-
SET (Speech Entrainment Therapy) 6 weeksSET (Speech Entrainment Therapy) 6 weeks-
No Therapy 6 weeksNo Therapy 6 Weeks-
Primary Outcome Measures
NameTimeMethod
Average Verbs Per Minute (VPM) Change From Baseline3 months after treatment (or no treatment)

VPM will be assessed through procedural storytelling and narrative storytelling tasks - with four items in each category. The procedural storytelling items are: 1) how to make a peanut butter and jelly sandwich, 2) how to make scrambled eggs, 3) how to brew coffee, and 4) how to wash dishes.

The narrative items will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks.

VPM is averaged between the procedural storytelling and narrative storytelling tasks.

Secondary Outcome Measures
NameTimeMethod
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline3 months after treatment (or no treatment)

Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) is a health-related quality of life measure that evaluates a participant's physical, psychosocial, and communication functioning. The final score is a decimal number between 0 and 5 with 5 indicating the best quality of life.

Narrative Verbs Per Minute (VPM)3 months after treatment (or no treatment)

VPM will be assessed through narrative storytelling tasks - with four different stories. The narrative stories will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks.

Procedural Verbs Per Minute (VPM) Change From Baseline3 months after treatment (or no treatment)

Verbs per minute (VPM) will be assessed through procedural storytelling - with four different stories. The procedural storytelling items are: 1) how to make a peanut butter and jelly sandwich, 2) how to make scrambled eggs, 3) how to brew coffee, and 4) how to wash dishes.

Trial Locations

Locations (3)

University of South Carolina

🇺🇸

Columbia, South Carolina, United States

University of Utah

🇺🇸

Salt Lake City, Utah, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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