PCT for Speech, Language, and Cognitive Intervention in Stroke Patients

Aphasia, Acquired Clinical Trial

Official title:

A Parallel, Virtual, Randomized Trial of PCT for Speech, Language, and Cognitive Intervention in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488029
• Other study ID #: TLC-PCT-Pilot
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: July 2020
• Source: The Learning Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Acquired

Intervention

Other:
• PCT
PCT is designed to deliver similar therapy as is conventionally provided in-clinic by a Speech Language Pathologist (SLP), which the patient can access from any location using the application installed on a supported tablet. The device functions by allowing clinicians to create a personalized therapy program for each patient from 75 categories of clinical therapies, which patients may access from their tablet device remotely. The PCT software is comprised primarily of authentication and an algorithm that suggests advancement of the therapy program based on observed patient deficits and progress.
• Workbooks
Subjects in this group will be provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia: Exercises for Expressive and Receptive Language Functioning; Brubaker, 2006) that are typically used by clinicians to practice therapy tasks with individuals. Notably, the control procedure employed here is similar to that employed on a large-scale study examining technology as a treatment option and involved usual care control group by Palmer and colleagues (2015).

Locations

Country	Name	City	State
United States	The Learning Corp	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The Learning Corp

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Epub 2006 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)	The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.	Baseline assessment
Primary	Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)	The WAB-R is a standardized tool that assesses language and cognitive skills and provides scores quantifying the impact of a stroke on those skills. The Aphasia Quotient from the WAB-R includes segments from Part 1 of the assessment, evaluating spontaneous speech including fluency and information content, auditory comprehension, naming, and repetition.	Follow-up assessment 10-12 weeks post baseline
Secondary	Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)	The Cortical Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R includes reading, writing, apraxia, constructional, visuospatial, and calculation sections.	Baseline assessment
Secondary	Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)	The Cortical Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R includes reading, writing, apraxia, constructional, visuospatial, and calculation sections.	Follow-up assessment 10-12 weeks post baseline
Secondary	Western Aphasia Battery Revised, Language Quotient (WAB-LQ)	The Language Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R informing the Language Quotients includes reading and writing sections.	Baseline assessment
Secondary	Western Aphasia Battery Revised, Language Quotient (WAB-LQ)	The Language Quotient as obtained from the WAB-R Parts 1 and 2 was utilized as secondary outcome measures. Part 2 of the WAB-R informing the Language Quotients includes reading and writing sections.	Follow-up assessment 10-12 weeks post baseline
Secondary	Brief Test of Adult Cognition by Telephone (BTACT)	The BTACT is a brief, remote, cognitive assessment that evaluates memory for and judgments about words and numbers. It includes tasks such as recall tasks, both immediate and short term, category fluency, and number reasoning and manipulation tasks.	Baseline assessment
Secondary	Brief Test of Adult Cognition by Telephone (BTACT)	The BTACT is a brief, remote, cognitive assessment that evaluates memory for and judgments about words and numbers. It includes tasks such as recall tasks, both immediate and short term, category fluency, and number reasoning and manipulation tasks.	Follow-up assessment 10-12 weeks post baseline
Secondary	Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)	The SAQOL-39 is a structured quality of life questionnaire administered to either a patient or a caregiver. It assesses the impact of a stroke on daily activities, communication, emotions, and family and social life by asking patients or caregivers to complete a 5 point rating scale in response to specific questions focusing on the past week alone.	Baseline assessment
Secondary	Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)	The SAQOL-39 is a structured quality of life questionnaire administered to either a patient or a caregiver. It assesses the impact of a stroke on daily activities, communication, emotions, and family and social life by asking patients or caregivers to complete a 5 point rating scale in response to specific questions focusing on the past week alone.	Follow-up assessment 10-12 weeks post baseline