Recovernow: Tablet-Based Speech Therapy For Post-Stroke Aphasia

NCT03755063 | Terminated

• 1 other identifier: 20180252-01H
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

RECOVERNOW is A MULTICENTRE PHASE II RANDOMIZED CONTROLLED TRIAL OF EARLY MOBILE TABLET-BASED SPEECH THERAPY FOR ACUTE STROKE PATIENTS WITH APHASIA. Using a novel futility design, investigators will randomize acute care in-patients with stroke to mobile tablet-based speech therapy applications vs the standard of care. Primary outcome is improvement in the Western Aphasia Battery Aphasia (WAB-R) Overall Study Aim: The primary study aim is to determine the futility and potential efficacy of mobile tablet-based speech therapy for post stroke aphasia. Primary Endpoint: The primary outcome measure is change in the Aphasia quotient (AQ) from the WAB-R at 90 days. The WAB-R is a standardized aphasia battery. The AQ is calculated from four language sub-tests measuring spontaneous speech, word comprehension, repetition, and word finding.) Secondary Endpoints: The results of the cost-effectiveness analysis will be expressed as the incremental cost per one-unit improvement in AQ and the incremental cost per one quality-adjusted life year (QALY) gained. Population: 226 participants will be enrolled over 3 years. Males and females, \>18 years of age, with diagnosis of acute ischemic/hemorrhagic stroke confirmed by routine head computerized tomography (CT) scan with mild to moderate aphasia. Phase: II Number of Sites: It is anticipated that this will be a multi-center study, with the following facilities participating: The Ottawa Hospital, Ottawa, ON, Foothills Medical Centre, Calgary, Alberta and Toronto Western Hospital. Protocol Therapy: Patients will be randomized 1:1 to receive either tablets with speech therapy apps (intervention group) or standard of care. Study Duration: It is estimated that recruitment will take place over 3 years in the three participating centers. Subject Participation Duration: All patients will be assessed clinically at baseline and Day 90 (+/-10).

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (1)

• Change in Western Aphasia Battery (WAB-R) scores

  Is a diagnostic tool used to assess the linguistic skills and main nonlinguistic skills of adults with aphasia. This provides information for the diagnosis of the type of aphasia and identifies the location of the lesion causing aphasia.This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild

  3 years

Secondary Outcomes (1)

• Cost-effectiveness

  3 years

Other Outcomes (7)

• Stroke and Aphasia Quality of Life Scale

  3 years

• Communicative Effectiveness Index (CETI)

  3 years

• Cognitive Linguistic Quick Test-Plus (CLQT+)

  3 years

Study Arms (2)

Treatment arm

EXPERIMENTAL

Tablet with speech therapy apps

Other: Speech therapy apps

Standard of Care

NO INTERVENTION

The standard care provided by speech language therapists.

Interventions

Speech therapy apps OTHER

Speech therapy apps loaded on tablets

Treatment arm

Eligibility Criteria

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

You may qualify if:

• diagnosis of ischemic/hemorrhagic stroke documented with CT and/or MRI and,
• mild to moderate aphasia, and/or -) Scoring ≥ 1 on the Best Language parameters of the National Institute of Health Stroke Score (NIHSS).

You may not qualify if:

• Pre-existing speech, language or cognitive disorders (such as dementia, mild cognitive impairment),
• severe debilitating disease(s) that, in the opinion of the investigator, would preclude them from being able to complete the study to follow-up (ex: end-stage malignancy, ALS),
• Severe comprehension deficits (unable to follow simple one-step commands and/or unable to respond to yes/no questions reliably), and
• English is not the primary language
• subarachnoid, subdural and epidural hemorrhages.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network / University of Toronto

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Dar Dowlatshahi, MD PhD

  Scientific Investigator, OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 27, 2018
• Study Start: November 13, 2019
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)