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

Primary Purpose

Aphasia, Acquired

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PCT
Workbooks
Sponsored by
The Learning Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Learning Corp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group 1 [Conventional Workbook Therapy]

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 22, 2020
Last Updated
July 24, 2020
Sponsor
The Learning Corp
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1. Study Identification

Unique Protocol Identification Number
NCT04488029
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Learning Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Acquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group 1 [Conventional Workbook Therapy]
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PCT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Workbooks
Intervention Description
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).
Primary Outcome Measure Information:
Title
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
Description
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.
Time Frame
Baseline assessment
Title
Western Aphasia Battery Revised, Aphasia Quotient (WAB-AQ)
Description
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.
Time Frame
Follow-up assessment 10-12 weeks post baseline
Secondary Outcome Measure Information:
Title
Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
Description
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.
Time Frame
Baseline assessment
Title
Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ)
Description
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.
Time Frame
Follow-up assessment 10-12 weeks post baseline
Title
Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
Description
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.
Time Frame
Baseline assessment
Title
Western Aphasia Battery Revised, Language Quotient (WAB-LQ)
Description
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.
Time Frame
Follow-up assessment 10-12 weeks post baseline
Title
Brief Test of Adult Cognition by Telephone (BTACT)
Description
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.
Time Frame
Baseline assessment
Title
Brief Test of Adult Cognition by Telephone (BTACT)
Description
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.
Time Frame
Follow-up assessment 10-12 weeks post baseline
Title
Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
Description
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.
Time Frame
Baseline assessment
Title
Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39)
Description
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.
Time Frame
Follow-up assessment 10-12 weeks post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swathi Kiran, PhD, CCC-SLP
Organizational Affiliation
The Learning Corp
Official's Role
Study Director
Facility Information:
Facility Name
The Learning Corp
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02458
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified, aggregate only. Data will be available at the request of other investigators for purposes of replicating procedures and results. Anonymized data will be shared by request from any qualified investigator.
Citations:
PubMed Identifier
29990345
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.
Results Reference
background
PubMed Identifier
16943264
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.
Results Reference
background
PubMed Identifier
32191122
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.
Results Reference
background
PubMed Identifier
22472032
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.
Results Reference
background
PubMed Identifier
33643204
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.
Results Reference
derived

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

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