Clinical trial NCT04488029: PCT for Speech, Language, and Cognitive Intervention in Stroke Patients
Official title: A Parallel, Virtual, Randomized Trial of PCT for Speech, Language, and Cognitive Intervention in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aphasia, Acquired
Lead sponsor: The Learning Corp
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Final study eligibility will be assessed after administration of the Western Aphasia Battery, Revised (WAB-R). Eligible subjects will be pseudorandomly assigned to the experimental group OR the control group, while trying to balance for aphasia severity (WAB-R Aphasia Quotient, WAB-AQ). Subjects in the experimental group will receive therapy via the PCT app during the treatment period. Subjects in the control arm will receive conventional workbook therapy. Subjects in both groups will be asked to refrain from obtaining one-on-one individual aphasia or cognitive therapy. Subjects may participate in organized social groups, such as community aphasia groups.
Primary purpose: TREATMENT

Brief summary: Given the evolving uses of technology in rehabilitation, the investigators aimed to measure the change in aphasia severity using PCT App, a digital therapeutic adapted from Constant Therapy (CT), a dynamic, personalized therapy program for people with cognitive, speech, or language disorders.

The entire study, including recruitment, enrollment, assessment and treatment were conducted remotely.

The proposed pilot study seeks to compare performance of PCT therapy vs. conventional workbook intervention for stroke patients. The investigators hypothesize that the experimental (PCT) group will experience greater gains on the WAB-AQ at follow-up compared to baseline compared to a control (workbook) group.

Subjects were prospectively assigned to an experimental or active control group in a random order with both groups balanced for their baseline level of speech, language and/or cognitive ability:

1. Experimental Group: Participants were instructed to use PCT for at least 30 minutes/day, 5 days/week. Performance and usage data were automatically reported by the PCT software to the treating clinician and was used to modify task assignment over time and monitor participant adherence to the treatment program.
2. Active Control Group: Participants were provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia; Brubaker, 2006) that are typically used by clinicians with persons with aphasia (PWA) for at least 30 minutes/day, 5 days/week. Notably, the control procedure employed here is similar to a large-scale study examining technology as a treatment option by Palmer and colleagues (2015).

The treatment period was 10 weeks. All participants received a bimonthly check-in through video-chat with a member of the research staff during the treatment period.


Eligibility criteria: Inclusion criteria:

* Have diagnosis of stroke involving a hemorrhage or ischemic event, resulting in speech, language, and/or cognitive deficits
* Have time post-stroke of at least 4 months prior to enrollment
* Have been discharged from rehabilitation hospital
* Are adults (aged 18 years or older) at the time of consent
* Exhibit clinically confirmed speech, language, and/or cognitive deficits based on medical records
* Are fluent English speakers
* Have confirmed aphasia using the WAB-R Aphasia Quotient (score of 90 or lower; 93.8 is cutoff for normal scores)
* Have a presence of a family member or caregiver who is willing and able to provide assistance during the duration of study period

Exclusion Criteria:

* Have comorbid neurological conditions that could impair study participation in the opinion of the investigator, such as dementia or Parkinson's disease
* Currently require inpatient care or acute care
* Are currently undergoing related one-on-one individual therapy at a hospital, rehabilitation facility, university, or at home
* Exhibit severe apraxia of speech or severe dysarthria of speech, as verified by a clinician and confirmed by the WAB-R (and the Screen for Dysarthria and Apraxia of Speech if necessary), and/or medical records
* Have comorbid psychiatric conditions that could impair study participation in the opinion of the investigator, including such as schizophrenia or major depressive disorder, as indicated by medical records
* Have uncorrected hearing or vision loss

Primary outcomes:
measure: Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
timeFrame: Baseline assessment
measure: Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
timeFrame: Follow-up assessment 10-12 weeks post baseline
Secondary outcomes:
measure: Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
timeFrame: Baseline assessment
measure: Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
timeFrame: Follow-up assessment 10-12 weeks post baseline
measure: Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
timeFrame: Baseline assessment
measure: Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
timeFrame: Follow-up assessment 10-12 weeks post baseline
measure: Brief Test of Adult Cognition by Telephone (BTACT)
timeFrame: Baseline assessment
measure: Brief Test of Adult Cognition by Telephone (BTACT)
timeFrame: Follow-up assessment 10-12 weeks post baseline
measure: Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
timeFrame: Baseline assessment
measure: Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
timeFrame: Follow-up assessment 10-12 weeks post baseline
Other outcomes:
Locations:
city: Newton
country: United States
facility: The Learning Corp
state: Massachusetts
Study officials:
affiliation: The Learning Corp
name: Swathi Kiran, PhD, CCC-SLP
role: STUDY_DIRECTOR
References:
citation: Palmer R, Witts H, Chater T. What speech and language therapy do community dwelling stroke survivors with aphasia receive in the UK? PLoS One. 2018 Jul 10;13(7):e0200096. doi: 10.1371/journal.pone.0200096. eCollection 2018.
citation: Tun PA, Lachman ME. Telephone assessment of cognitive function in adulthood: the Brief Test of Adult Cognition by Telephone. Age Ageing. 2006 Nov;35(6):629-32. doi: 10.1093/ageing/afl095. Epub 2006 Aug 30. No abstract available.
citation: Dekhtyar M, Braun EJ, Billot A, Foo L, Kiran S. Videoconference Administration of the Western Aphasia Battery-Revised: Feasibility and Validity. Am J Speech Lang Pathol. 2020 May 8;29(2):673-687. doi: 10.1044/2019_AJSLP-19-00023. Epub 2020 Mar 19.
citation: Caute A, Northcott S, Clarkson L, Pring T, Hilari K. Does mode of administration affect health-related quality-of-life outcomes after stroke? Int J Speech Lang Pathol. 2012 Aug;14(4):329-37. doi: 10.3109/17549507.2012.663789. Epub 2012 Apr 4.
citation: Braley M, Pierce JS, Saxena S, De Oliveira E, Taraboanta L, Anantha V, Lakhan SE, Kiran S. A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia. Front Neurol. 2021 Feb 12;12:626780. doi: 10.3389/fneur.2021.626780. eCollection 2021.