NCT02615132

Brief Summary

Post-stroke communication deficits (PSCD) are a common symptom of patients having sustained a stroke. These deficits include difficulty to produce or understand language, motor speech disorders and cognitive-communication disorders. It is estimated that approximately 40% of stroke survivors will have communication disorders post stroke. In this randomized controlled study, the investigators' objective is to test the value of providing a mobile platform-based Speech Language Therapy (SLT) program to patients discharged from an acute care hospital with stroke and PSCD and awaiting outpatient rehab services versus standard of care treatment. The investigators will offer iPad-based SLT/standard of treatment to a convenience sample of 20 patients with post-stroke communication deficits. The primary outcome will be feasibility (recruitment rate, adherence rate, retention rate, and protocol deviations), and the secondary outcome will be improvement in PSCD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

November 22, 2015

Results QC Date

November 4, 2023

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recruitment

    The investigators will assess the primary outcome of recruitment by determining: Total number of patients enrolled. This is the numerical total of all patients enrolled in the study

    13 months

Secondary Outcomes (3)

  • Retention Rate

    8 week follow up

  • Adherence Rate

    8 week follow up

  • Percentage of Patients Being Engaged in Study

    8 week follow up

Other Outcomes (1)

  • Exploratory Outcome (Potential Improvement)

    8 week follow up

Study Arms (2)

Treatment Group

EXPERIMENTAL

The study SLP will instruct the patient to use the ipad apps as intervention for at least one-hour per day, until they are admitted to outpatient SLP services or for a maximum of 8 weeks, whichever comes first. Throughout the telemedicine treatment phase, patients' progress will be monitored remotely by a study SLP through Apps/Skype/Facetime/Telephone consultation on a weekly basis.

Behavioral: iPad

Control

NO INTERVENTION

Patients will be sent home with standard of care.

Interventions

iPadBEHAVIORAL

Using iPad speech therapy apps on patients with post-stroke communication deficits

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of stroke being discharged from the Neurology unit and/or the Neurology Acute Care Unit in the Civic Campus of TOH.
  • Patients presenting with overall mild to moderate communication deficits, And/or
  • Patients with score ≥ 1 on the best language and/or dysarthria parameters of the National Institute of Health Stroke Score (NIHSS)
  • Stroke Patients being discharged to their HOME/PRIMARY RESIDENCE awaiting outpatient speech and language therapy services.
  • And/or
  • Patients being discharged to their HOME/PRIMARY RESIDENCE who would benefit from SLP therapy services but are unable to receive these secondary to various accessibility challenges (i.e. remote geographical location, limited service availability, transportation, unable to pay for SLP services).
  • Patients must have access to Wi-Fi connection at their HOME/PRIMARY RESIDENCE.

You may not qualify if:

  • \. Patients with pre-existing speech, language disorders or cognitive disorders (such as dementia).
  • \. Patients with severe debilitating disease(s) that, in the opinion, of the investigator will not be able to perform the required tasks of the study (ex: end-stage malignancy, ALS).
  • \. Patients with severe comprehension deficits 4. Patients not having access to Wi-Fi connection at HOME/PRIMARY RESIDENCE. 5. Patients who will be accessing the services of a private SLP while awaiting outpatient rehab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location

Related Publications (2)

  • Berthier ML. Poststroke aphasia : epidemiology, pathophysiology and treatment. Drugs Aging. 2005;22(2):163-82. doi: 10.2165/00002512-200522020-00006.

    PMID: 15733022BACKGROUND
  • Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.

    PMID: 15947263BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Karen Mallet
Organization
Champlain Regional Stroke Network & Ottawa Hospital Research Institute

Study Officials

  • Karen Mallet, M.H.Sc

    Speech language Pathologist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2015

First Posted

November 26, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

May 6, 2026

Results First Posted

May 6, 2026

Record last verified: 2026-05

Locations