Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Western Aphasia Battery Revised, Cortical Quotient (WAB-CQ) |
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Swathi Kiran, PhD, CCC-SLP | The Learning Corp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Learning Corp | Newton | Massachusetts | 02458 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29990345 | Background | 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. | |
| 16943264 | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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). |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 32191122 | 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. |
| 22472032 | 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. |
| 33643204 | Derived | 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |