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

NCT04488029 | Completed Phase 2

• 1 other identifier: TLC-PCT-Pilot
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Aphasia, Acquired

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)

  Baseline assessment

• Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)

  Follow-up assessment 10-12 weeks post baseline

• Western Aphasia Battery Revised, Language Quotient (WAB-LQ)

  Baseline assessment

• Western Aphasia Battery Revised, Language Quotient (WAB-LQ)

  Follow-up assessment 10-12 weeks post baseline

• Brief Test of Adult Cognition by Telephone (BTACT)

  Baseline assessment

Study Arms (2)

Experimental Group

EXPERIMENTAL

At the start of the study, subjects will be provided with a tablet with videoconferencing software and the PCT app pre-installed. Research staff will remotely setup a PCT account for the subjects, and provide instructions for logging into the PCT application. During the treatment period, patients will be instructed to use PCT for at least 30 minutes a day and at least 5 days a week. Performance data (accuracy and latency) will be reported by the PCT software to the treating clinician and will be used to modify task assignment over time. PCT tracks usage of the program so that research staff can access automated reporting of subject use to monitor participant adherence to the treatment program.

Other: PCT

Control Group 1 [Conventional Workbook Therapy]

ACTIVE COMPARATOR

At the start of the study, subjects will be provided with a tablet with videoconferencing software and the PCT app pre-installed. Subjects in the control group will be told they will have access to 3-months of PCT after their participation in the study has concluded. Subjects in this group will be provided with a standard regime of paper workbooks and instructions to complete approximately 30 minutes a day at least 5 days a week.

Other: Workbooks

Interventions

PCT OTHER

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.

Experimental Group

Workbooks OTHER

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).

Control Group 1 [Conventional Workbook Therapy]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Learning Corp: lead

Study Sites (1)

The Learning Corp

Newton, Massachusetts, 02458, United States

Location

Related Publications (5)

• 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.

  PMID: 29990345 BACKGROUND

• 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.

  PMID: 16943264 BACKGROUND

• 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.

  PMID: 32191122 BACKGROUND

• 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.

  PMID: 22472032 BACKGROUND

• 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.

  PMID: 33643204 DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Swathi Kiran, PhD, CCC-SLP

  The Learning Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator/Senior Manager of Clinical Science

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: March 18, 2019
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)