Status:

COMPLETED

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

Lead Sponsor:

The Learning Corp

Conditions:

Aphasia, Acquired

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 dy...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 18 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 20 2020

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT04488029

    Start Date

    March 18 2019

    End Date

    February 20 2020

    Last Update

    July 27 2020

    Active Locations (1)

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    The Learning Corp

    Newton, Massachusetts, United States, 02458