Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687994
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-01-09
Brief Title:
Speech Entrainment Treatment for People With Aphasia
Sponsor:
Albert Einstein Healthcare Network
Organization:
Albert Einstein Healthcare Network
Study Overview
Official Title:
Efficacy and Optimization of Speech Entrainment Practice for People With Aphasia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this research is to experimentally delineate the direct effect of speech entrainment practice on independent speech production and identify practice conditions that enhance treatment benefits The primary outcome measure Correct Information Units per minute tallies informativeness and efficiency of independent speech in treated stories
Detailed Description:
Speech entrainment refers to speaking in unison with a model speaker by imitating the model in real time The objective of the study is to 1 experimentally establish the direct effect of speech entrainment practice on independent speech production post-treatment and 2 identify conditions that enhance treatment benefits These aims are addressed in a within-subject efficacy study where 40 people with aphasia produce different stories with entrainment support Speaking without entrainment is evaluated one day before and one day after speech entrainment practice Different practice stories will be randomized within participants to three experimental conditions to assess the effect of treatment trained vs untrained training schedule massed vs distributed presentation of stories and entrainment modality practice with auditory-only or audiovisual model Correct information units per minute for each story will be tallied to evaluate the differences between conditions and the associations with patient characteristics For consistency with prior research number of different words per minute will serve as a secondary outcome The proposed research addresses a clinical need by testing and optimizing a promising treatment technique for enhancing aphasia rehabilitation
This proof-of-concept study is the first to evaluate the direct effect of speech entrainment practice on independent speech Thus the effect size for accurate power estimation is not known The strategy for this study is to optimize experimental sensitivity by maximizing the number of observations per participants per condition within the constraints of feasibility The results from this study will provide critical information for evaluating the effect size for a subsequent phase Nevertheless to estimate an optimal sample size the investigators leveraged the data from our Pilot Study which examines the speech entrainment effect on immediate performance rather than learning With 13 participants the investigators estimated 80 power to detect the effect of 08 mean difference between groups divided by the pooled standard deviation observed in our pilot study for speaking with audiovisual speech entrainment vs independent speech Aim 1 The calculation is based on a paired t-test with an alpha of 05 two-tailed and a correlation of 05 between groups With 24 participants there is 80 power to detect the observed effect of 06 for speaking with audiovisual speech entrainment vs auditory-only speech entrainment alpha is set to 05 two-tailed correlation between groups is 57 Aim 2b The investigators have substantially increased the sample size N40 with the consideration that learning effects the focus of the present study are expected to be smaller than performance effects the focus of the Pilot Study
This proof-of-concept study is the first to evaluate the direct effect of speech entrainment practice on independent speech Thus the effect size for accurate power estimation is not known The strategy for this study is to optimize experimental sensitivity by maximizing the number of observations per participants per condition within the constraints of feasibility The results from this study will provide critical information for evaluating the effect size for a subsequent phase Nevertheless to estimate an optimal sample size the investigators leveraged the data from our Pilot Study which examines the speech entrainment effect on immediate performance rather than learning With 13 participants the investigators estimated 80 power to detect the effect of 08 mean difference between groups divided by the pooled standard deviation observed in our pilot study for speaking with audiovisual speech entrainment vs independent speech Aim 1 The calculation is based on a paired t-test with an alpha of 05 two-tailed and a correlation of 05 between groups With 24 participants there is 80 power to detect the observed effect of 06 for speaking with audiovisual speech entrainment vs auditory-only speech entrainment alpha is set to 05 two-tailed correlation between groups is 57 Aim 2b The investigators have substantially increased the sample size N40 with the consideration that learning effects the focus of the present study are expected to be smaller than performance effects the focus of the Pilot Study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21DC018893 | NIH | None | httpsreporternihgovquickSearchR21DC018893 |